NCT04208321 is a Phase 1 clinical trial of VT-1598 in Coccidioidomycosis, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Who is sponsoring NCT04208321?

NCT04208321 is sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

What drugs are being tested in NCT04208321?

Interventions in NCT04208321: Placebo, VT-1598.

What condition does NCT04208321 study?

NCT04208321 studies Coccidioidomycosis.

Is NCT04208321 still recruiting?

NCT04208321 is currently completed. Last updated 26 July 2024.

Are results published for NCT04208321?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-07-26 · How we verify

NCT04208321

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Safety and Pharmacokinetics of VT-1598

Completed Phase 1 Results posted Last updated 26 July 2024

What this trial tests

Phase 1 trial testing Placebo in Coccidioidomycosis in 48 participants. Completed in 27 December 2021.

Timeline

29 September 2020

Primary endpoint
27 December 2021

27 December 2021

Quick facts

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	double
Primary purpose	treatment
Enrollment	48
Start date	29 September 2020
Primary completion	27 December 2021
Estimated completion	27 December 2021
Sites	1 location across United States

Drugs / interventions tested

Placebo
VT-1598 — full drug profile →

Conditions studied

Coccidioidomycosis — all drugs for Coccidioidomycosis →

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Who can join

Adults 18 to 45, any sex, with Coccidioidomycosis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Unsolicited Adverse Events Primary · Day 1 through Day 21

Adverse events (AEs) are defined as any untoward medical occurrence regardless of its causal relationship to study treatment. Number of participants with an AE are summarized by MedDRA System Organ Class (SOC). Each subject was counted once per SOC. If a condition was present at screening, it was not considered an AE unless the severity worsened.

General disorders and administration site conditions

Group	Value	95% CI
40 mg Fasted	0
80 mg Fasted	0
160 mg Fasted	0
160 mg Fed	0
320 mg Fasted	0
640 mg Fasted	0
Placebo	1

Infections and infestations

Group	Value	95% CI
40 mg Fasted	0
80 mg Fasted	1
160 mg Fasted	0
160 mg Fed	0
320 mg Fasted	0
640 mg Fasted	0
Placebo	0

Injury, poisoning and procedural complications

Group	Value	95% CI
40 mg Fasted	0
80 mg Fasted	0
160 mg Fasted	0
160 mg Fed	0
320 mg Fasted	0
640 mg Fasted	0
Placebo	1

Investigations

Group	Value	95% CI
40 mg Fasted	6
80 mg Fasted	6
160 mg Fasted	6
160 mg Fed	5
320 mg Fasted	3
640 mg Fasted	5
Placebo	11

Musculoskeletal and connective tissue disorders

Group	Value	95% CI
40 mg Fasted	0
80 mg Fasted	0
160 mg Fasted	0
160 mg Fed	0
320 mg Fasted	1
640 mg Fasted	0
Placebo	0

Nervous system disorders

Group	Value	95% CI
40 mg Fasted	0
80 mg Fasted	0
160 mg Fasted	1
160 mg Fed	0
320 mg Fasted	0
640 mg Fasted	0
Placebo	0

Number of Participants With Abnormal Chemistry Laboratory Toxicity Results Primary · Baseline (Day -1) through Day 21

Laboratory parameters and associated thresholds include albumin \<=3.4 g/dL, glucose \<= 69 mg/dL or \>=106 mg/dL, blood urea nitrogen (BUN) \>= 21 mg/dL, potassium \>=5.2 mEq/L or \<=3.4 mEq/L, calcium \< 8.7 mg/dL or \>=10.3 mg/dL, sodium \<=132 mEq/L or \>=144 mEq/L, total protein \<=5.9 g/dL, creatinine \>=1.3 mg/dL (male) or \>= 1.0 mg/dL (female), creatine phosphokinase \>= 308 U/L (male) or \>=192 U/L (female), phosphorus \<=2.4 mg/dL, alkaline phosphatase \>= 130 IU/L (males) or \>= 105 IU/L (female), aspartate aminotransferase \>= 39.9 U/L (male) or \>= 31.9 U/L (female), alanine amin

Albumin, Decrease

Group	Value	95% CI
40 mg Fasted	0
80 mg Fasted	0
160 mg Fasted	0
160 mg Fed	0
320 mg Fasted	0
640 mg Fasted	0
Placebo	0

Glucose, Decrease

Group	Value	95% CI
40 mg Fasted	0
80 mg Fasted	0
160 mg Fasted	0
160 mg Fed	0
320 mg Fasted	0
640 mg Fasted	0
Placebo	0

Glucose, Increase

Group	Value	95% CI
40 mg Fasted	4
80 mg Fasted	2
160 mg Fasted	3
160 mg Fed	3
320 mg Fasted	1
640 mg Fasted	3
Placebo	4

Blood Urea Nitrogen, Increase

Group	Value	95% CI
40 mg Fasted	1
80 mg Fasted	0
160 mg Fasted	1
160 mg Fed	0
320 mg Fasted	0
640 mg Fasted	1
Placebo	1

Potassium, Decrease

Group	Value	95% CI
40 mg Fasted	0
80 mg Fasted	0
160 mg Fasted	0
160 mg Fed	1
320 mg Fasted	0
640 mg Fasted	0
Placebo	0

Potassium, Increase

Group	Value	95% CI
40 mg Fasted	0
80 mg Fasted	0
160 mg Fasted	0
160 mg Fed	0
320 mg Fasted	0
640 mg Fasted	0
Placebo	2

Calcium, Decrease

Group	Value	95% CI
40 mg Fasted	0
80 mg Fasted	1
160 mg Fasted	0
160 mg Fed	1
320 mg Fasted	2
640 mg Fasted	0
Placebo	3

Calcium, Increase

Group	Value	95% CI
40 mg Fasted	0
80 mg Fasted	0
160 mg Fasted	1
160 mg Fed	0
320 mg Fasted	0
640 mg Fasted	0
Placebo	2

Number of Participants With Abnormal Hematology Laboratory Toxicity Results Primary · Baseline (Day -1) through Day 21

Laboratory parameters and associated thresholds for adverse events include hemoglobin \<= 12.2 g/dL (male) or \<= 10.8 g/dL (female), hematocrit \<= 36.1 % (male) or \<= 32.6 % (female), lymphocyte count \<= 799 cell/mm3, neutrophil count \<= 1,299 cell/mm3 (African Americans) or \<= 1,699 cell/mm3 (all others), monocyte count \>= 1001 cell/mm3, eosinophil count \>= 871 cell/mm3, basophil count \>= 101 cell/mm3, platelet count \<= 150 x 10\^3/mm3, red blood cell (RBC) count \<= 4.1 x 10\^6/uL (male) or \<= 3.7 x 10\^6/uL (female), and white blood cell (WBC) count \>= 9,001 cell/mm3 or \<= 2,49

Hemoglobin, Decrease

Group	Value	95% CI
40 mg Fasted	1
80 mg Fasted	1
160 mg Fasted	0
160 mg Fed	0
320 mg Fasted	0
640 mg Fasted	0
Placebo	1

Hematocrit, Decrease

Group	Value	95% CI
40 mg Fasted	0
80 mg Fasted	0
160 mg Fasted	0
160 mg Fed	0
320 mg Fasted	0
640 mg Fasted	0
Placebo	0

Lymphocytes, Decrease

Group	Value	95% CI
40 mg Fasted	0
80 mg Fasted	1
160 mg Fasted	0
160 mg Fed	0
320 mg Fasted	0
640 mg Fasted	0
Placebo	0

Neutrophils, Decrease

Group	Value	95% CI
40 mg Fasted	0
80 mg Fasted	0
160 mg Fasted	0
160 mg Fed	0
320 mg Fasted	0
640 mg Fasted	1
Placebo	1

Monocytes, Increase

Group	Value	95% CI
40 mg Fasted	0
80 mg Fasted	0
160 mg Fasted	0
160 mg Fed	0
320 mg Fasted	0
640 mg Fasted	0
Placebo	0

Eosinophils, Increase

Group	Value	95% CI
40 mg Fasted	0
80 mg Fasted	0
160 mg Fasted	0
160 mg Fed	1
320 mg Fasted	0
640 mg Fasted	0
Placebo	0

Basophils, Increase

Group	Value	95% CI
40 mg Fasted	0
80 mg Fasted	0
160 mg Fasted	0
160 mg Fed	1
320 mg Fasted	0
640 mg Fasted	0
Placebo	0

Platelets, Decrease

Group	Value	95% CI
40 mg Fasted	0
80 mg Fasted	0
160 mg Fasted	0
160 mg Fed	0
320 mg Fasted	0
640 mg Fasted	0
Placebo	0

Number of Participants With Abnormal Coagulation Laboratory Toxicity Results Primary · Baseline (Day -1) through Day 21

Laboratory parameters include prothrombin time (PT), activated partial prothrombin time (PTT), and prothrombin international normalized ratio (INR). Thresholds for adverse events were considered as PT \>= 11.6 s, PTT \>= 30.1 s, INR \>= 1.2. If a coagulation laboratory value met the threshold for an AE at baseline, subsequent safety laboratory results were only considered to be an AE if the grading worsened in severity.

Activated Partial Thromboplastin Time, Increase

Group	Value	95% CI
40 mg Fasted	0
80 mg Fasted	0
160 mg Fasted	1
160 mg Fed	2
320 mg Fasted	0
640 mg Fasted	1
Placebo	2

Prothrombin Time, Increase

Group	Value	95% CI
40 mg Fasted	0
80 mg Fasted	0
160 mg Fasted	1
160 mg Fed	0
320 mg Fasted	0
640 mg Fasted	1
Placebo	2

Prothrombin International Normalized Ratio, Increase

Group	Value	95% CI
40 mg Fasted	0
80 mg Fasted	0
160 mg Fasted	0
160 mg Fed	0
320 mg Fasted	0
640 mg Fasted	0
Placebo	0

Number of Participants With Abnormal Urinalysis Laboratory Toxicity Results Primary · Baseline (Day -1) through Day 21

The only graded urinalysis laboratory parameter was red blood cells (RBC) by complete urinalysis. The threshold for adverse events was considered as \>=3. If a urinalysis laboratory value met the threshold for an AE at baseline, subsequent safety laboratory results were only considered to be an AE if the grading worsened in severity.

Group	Value	95% CI
40 mg Fasted	1
80 mg Fasted	0
160 mg Fasted	0
160 mg Fed	0
320 mg Fasted	0
640 mg Fasted	0
Placebo	2

Number of Participants With Abnormal Electrocardiogram (ECG) Toxicity Results Primary · Day 1 through Day 21

Each participant is only counted once per toxicity grade for the worst severity recorded. The only ECG parameter graded was QTcF interval with a threshold of \>= 30 msec. If an ECG value met the threshold for an AE at baseline, subsequent safety ECG results were only considered to be an AE if the grading worsened in severity.

Group	Value	95% CI
40 mg Fasted	0
80 mg Fasted	0
160 mg Fasted	0
160 mg Fed	0
320 mg Fasted	0
640 mg Fasted	0
Placebo	0

Number of Participants With Abnormal Vital Signs Primary · Baseline (Day -1) through Day 21

Each participant is only counted once per toxicity grade for the worst severity recorded. Vital sign parameters include systolic blood pressure (BP), diastolic BP, pulse, respiratory rate, and temperature. Thresholds for abnormal vital signs were considered as systolic BP \>= 141 mmHg or \<= 89 mmHg, diastolic BP \>= 91 mmHg, pulse \<= 54 bpm (baseline \> 60 bpm) or \<=50 (baseline \<= 60 bpm) or \>= 101 bpm, respiratory rate \>= 17 breaths per minute, and temperature \>= 38.0 degrees Celsius. If a vital sign result met the threshold for an AE at baseline, subsequent vital sign results were on

Systolic Blood Pressure, Decrease

Group	Value	95% CI
40 mg Fasted	2
80 mg Fasted	1
160 mg Fasted	0
160 mg Fed	0
320 mg Fasted	0
640 mg Fasted	0
Placebo	1

Systolic Blood Pressure, Increase

Group	Value	95% CI
40 mg Fasted	0
80 mg Fasted	0
160 mg Fasted	0
160 mg Fed	1
320 mg Fasted	0
640 mg Fasted	0
Placebo	0

Diastolic Blood Pressure, Increase

Group	Value	95% CI
40 mg Fasted	1
80 mg Fasted	0
160 mg Fasted	0
160 mg Fed	0
320 mg Fasted	0
640 mg Fasted	0
Placebo	0

Pulse, Decrease

Group	Value	95% CI
40 mg Fasted	1
80 mg Fasted	2
160 mg Fasted	2
160 mg Fed	1
320 mg Fasted	0
640 mg Fasted	1
Placebo	2

Pulse, Increase

Group	Value	95% CI
40 mg Fasted	1
80 mg Fasted	0
160 mg Fasted	0
160 mg Fed	0
320 mg Fasted	0
640 mg Fasted	0
Placebo	0

Respiratory Rate, Increase

Group	Value	95% CI
40 mg Fasted	4
80 mg Fasted	5
160 mg Fasted	5
160 mg Fed	2
320 mg Fasted	4
640 mg Fasted	2
Placebo	6

Temperature, Increase

Group	Value	95% CI
40 mg Fasted	0
80 mg Fasted	1
160 mg Fasted	0
160 mg Fed	0
320 mg Fasted	0
640 mg Fasted	0
Placebo	0

VT-1598 Concentrations in Plasma Secondary · 0 hours (h), 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 24 h, 36 h, 48 h, 60 h, 72 h, 144 h, 312 h, and 480 h post dose

Mean and standard deviation of VT-1598 concentrations in plasma by nominal time point.

0 h

Group	Value	95% CI
40 mg Fasted	0.000	± 0.000
80 mg Fasted	0.000	± 0.000
160 mg Fasted	0.000	± 0.000
160 mg Fed	0.000	± 0.000
320 mg Fasted	0.000	± 0.000
640 mg Fasted	0.000	± 0.000

0.5 h

Group	Value	95% CI
40 mg Fasted	0.000	± 0.000
80 mg Fasted	0.000	± 0.000
160 mg Fasted	0.000	± 0.000
160 mg Fed	0.000	± 0.000
320 mg Fasted	0.000	± 0.000
640 mg Fasted	0.000	± 0.000

1 h

Group	Value	95% CI
40 mg Fasted	0.000	± 0.000
80 mg Fasted	0.000	± 0.000
160 mg Fasted	6.417	± 9.941
160 mg Fed	4.333	± 6.780
320 mg Fasted	8.117	± 12.574
640 mg Fasted	18.983	± 24.670

1.5 h

Group	Value	95% CI
40 mg Fasted	4.733	± 7.642
80 mg Fasted	7.067	± 11.546
160 mg Fasted	19.317	± 30.014
160 mg Fed	21.100	± 29.765
320 mg Fasted	26.183	± 21.945
640 mg Fasted	43.617	± 41.759

2 h

Group	Value	95% CI
40 mg Fasted	9.850	± 12.188
80 mg Fasted	14.633	± 25.117
160 mg Fasted	35.400	± 51.819
160 mg Fed	49.083	± 47.324
320 mg Fasted	56.550	± 36.542
640 mg Fasted	75.967	± 58.528

3 h

Group	Value	95% CI
40 mg Fasted	20.667	± 20.704
80 mg Fasted	41.400	± 46.900
160 mg Fasted	69.833	± 104.167
160 mg Fed	92.717	± 56.432
320 mg Fasted	136.850	± 76.482
640 mg Fasted	171.700	± 151.630

4 h

Group	Value	95% CI
40 mg Fasted	27.180	± 21.812
80 mg Fasted	57.517	± 56.493
160 mg Fasted	75.600	± 105.466
160 mg Fed	119.183	± 24.982
320 mg Fasted	192.900	± 141.040
640 mg Fasted	253.817	± 193.963

6 h

Group	Value	95% CI
40 mg Fasted	26.060	± 12.777
80 mg Fasted	55.283	± 39.530
160 mg Fasted	94.133	± 80.855
160 mg Fed	269.000	± 108.030
320 mg Fasted	193.167	± 96.837
640 mg Fasted	289.000	± 161.294

VT-11134 Concentrations in Plasma Secondary · 0 h, 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 24 h, 36 h, 48 h, 60 h, 72 h, 144 h, 312 h, and 480 h post dose

Mean and standard deviation of VT-11134 concentrations in plasma by nominal time point.

0 h

Group	Value	95% CI
40 mg Fasted	0.000	± 0.000
80 mg Fasted	0.000	± 0.000
160 mg Fasted	0.000	± 0.000
160 mg Fed	0.000	± 0.000
320 mg Fasted	0.000	± 0.000
640 mg Fasted	0.000	± 0.000

0.5 h

Group	Value	95% CI
40 mg Fasted	0.000	± 0.000
80 mg Fasted	0.000	± 0.000
160 mg Fasted	0.000	± 0.000
160 mg Fed	0.173	± 0.425
320 mg Fasted	0.000	± 0.000
640 mg Fasted	0.000	± 0.000

1 h

Group	Value	95% CI
40 mg Fasted	0.185	± 0.453
80 mg Fasted	0.000	± 0.000
160 mg Fasted	1.360	± 2.692
160 mg Fed	2.320	± 3.618
320 mg Fasted	2.462	± 3.858
640 mg Fasted	5.213	± 4.512

1.5 h

Group	Value	95% CI
40 mg Fasted	2.363	± 1.972
80 mg Fasted	0.417	± 0.662
160 mg Fasted	7.052	± 13.110
160 mg Fed	12.870	± 19.273
320 mg Fasted	10.290	± 9.801
640 mg Fasted	18.927	± 12.740

2 h

Group	Value	95% CI
40 mg Fasted	8.763	± 6.556
80 mg Fasted	1.575	± 1.908
160 mg Fasted	13.660	± 23.209
160 mg Fed	25.947	± 33.194
320 mg Fasted	24.652	± 18.888
640 mg Fasted	31.732	± 17.109

3 h

Group	Value	95% CI
40 mg Fasted	21.508	± 14.538
80 mg Fasted	9.078	± 8.322
160 mg Fasted	25.530	± 31.367
160 mg Fed	53.317	± 52.224
320 mg Fasted	54.845	± 35.132
640 mg Fasted	65.550	± 31.354

4 h

Group	Value	95% CI
40 mg Fasted	25.748	± 16.413
80 mg Fasted	17.412	± 10.501
160 mg Fasted	29.200	± 21.290
160 mg Fed	65.700	± 49.461
320 mg Fasted	67.117	± 40.162
640 mg Fasted	86.100	± 27.404

6 h

Group	Value	95% CI
40 mg Fasted	25.550	± 11.905
80 mg Fasted	28.478	± 13.949
160 mg Fasted	46.750	± 19.144
160 mg Fed	88.200	± 36.162
320 mg Fasted	71.200	± 35.140
640 mg Fasted	114.817	± 60.895

Maximum Observed Concentration (Cmax) of VT-1598 and VT-11134 Secondary · 0 h through 480 h post dose

Mean and standard deviation (SD) of the Cmax (ng/mL) PK parameter was estimated from the VT-1598 and VT-11134 plasma concentration-time data.

VT-1598

Group	Value	95% CI
40 mg Fasted	35.43	± 17.97
80 mg Fasted	63.93	± 50.38
160 mg Fasted	108.1	± 95.57
160 mg Fed	351.0	± 148.9
320 mg Fasted	222.2	± 121.4
640 mg Fasted	322.3	± 188.4

VT-11134

Group	Value	95% CI
40 mg Fasted	30.05	± 13.47
80 mg Fasted	28.51	± 13.89
160 mg Fasted	51.02	± 25.09
160 mg Fed	108.3	± 44.81
320 mg Fasted	73.63	± 37.55
640 mg Fasted	118.6	± 57.53

Dose-normalized Maximum Observed Concentration (Cmax/Dose) of VT-1598 and VT-11134 Secondary · 0 h through 480 h post dose

Mean and standard deviation (SD) of the dose-normalized Cmax (ng/mL) PK parameter was estimated from the VT-1598 and VT-11134 plasma concentration-time data.

VT-1598

Group	Value	95% CI
40 mg Fasted	0.8858	± 0.4492
80 mg Fasted	0.7992	± 0.6298
160 mg Fasted	0.6756	± 0.5973
160 mg Fed	2.194	± 0.9307
320 mg Fasted	0.6943	± 0.3793
640 mg Fasted	0.5036	± 0.2945

VT-11134

Group	Value	95% CI
40 mg Fasted	0.7513	± 0.3368
80 mg Fasted	0.3564	± 0.1737
160 mg Fasted	0.3189	± 0.1568
160 mg Fed	0.6769	± 0.2800
320 mg Fasted	0.2301	± 0.1173
640 mg Fasted	0.1853	± 0.08989

Time of Maximum Observed Concentration (Tmax) of VT-1598 and VT-11134 Secondary · 0 h through 480 h post dose

Mean and standard deviation (SD) of the Tmax (h) PK parameter was estimated from the VT-1598 and VT-11134 plasma concentration-time data.

VT-1598

Group	Value	95% CI
40 mg Fasted	5.00	± 2.68
80 mg Fasted	5.00	± 1.10
160 mg Fasted	4.83	± 1.33
160 mg Fed	8.17	± 3.49
320 mg Fasted	5.05	± 1.05
640 mg Fasted	4.83	± 1.33

VT-11134

Group	Value	95% CI
40 mg Fasted	5.50	± 2.51
80 mg Fasted	5.67	± 0.818
160 mg Fasted	5.17	± 1.33
160 mg Fed	7.67	± 2.94
320 mg Fasted	5.05	± 1.05
640 mg Fasted	6.33	± 1.97

Adverse events — posted to ClinicalTrials.gov

Time frame: Day 1 (ingestion of study product) through Day 21. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

40 mg Fasted

Serious: 0/6 (0%)

Deaths: 0/6

80 mg Fasted

Serious: 0/6 (0%)

Deaths: 0/6

160 mg Fasted

Serious: 0/6 (0%)

Deaths: 0/6

160 mg Fed

Serious: 0/6 (0%)

Deaths: 0/6

320 mg Fasted

Serious: 0/6 (0%)

Deaths: 0/6

640 mg Fasted

Serious: 0/6 (0%)

Deaths: 0/6

Placebo

Serious: 0/12 (0%)

Deaths: 0/12

Other adverse events (34 terms — click to expand)

Reaction	System	40 mg Fasted	80 mg Fasted	160 mg Fasted	160 mg Fed	320 mg Fasted	640 mg Fasted	Placebo
Respiratory rate increased	Investigations	—	—	—	—	—	—	—
Blood glucose increased	Investigations	—	—	—	—	—	—	—
Blood creatine phosphokinase increased	Investigations	—	—	—	—	—	—	—
Protein total decreased	Investigations	—	—	—	—	—	—	—
Blood calcium decreased	Investigations	—	—	—	—	—	—	—
Blood pressure systolic decreased	Investigations	—	—	—	—	—	—	—
Heart rate decreased	Investigations	—	—	—	—	—	—	—
Cortisol decreased	Investigations	—	—	—	—	—	—	—
Activated partial thromboplastin time prolonged	Investigations	—	—	—	—	—	—	—
Prothrombin time prolonged	Investigations	—	—	—	—	—	—	—
Blood calcium increased	Investigations	—	—	—	—	—	—	—
Infusion site thrombosis	General disorders	—	—	—	—	—	—	—
Respiratory tract infection viral	Infections and infestations	—	—	—	—	—	—	—
Wound	Injury, poisoning and procedural complications	—	—	—	—	—	—	—
Blood pressure diastolic increased	Investigations	—	—	—	—	—	—	—
Heart rate increased	Investigations	—	—	—	—	—	—	—
Blood alkaline phosphatase increased	Investigations	—	—	—	—	—	—	—
Basophil count increased	Investigations	—	—	—	—	—	—	—
Haemoglobin decreased	Investigations	—	—	—	—	—	—	—
Neutrophil count decreased	Investigations	—	—	—	—	—	—	—
Red blood cell count decreased	Investigations	—	—	—	—	—	—	—
White blood cell count decreased	Investigations	—	—	—	—	—	—	—
White blood cell count increased	Investigations	—	—	—	—	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—	—	—	—	—
Aspartate aminotransferase increased	Investigations	—	—	—	—	—	—	—
Bilirubin conjugated increased	Investigations	—	—	—	—	—	—	—
Blood urea increased	Investigations	—	—	—	—	—	—	—
Red blood cells urine positive	Investigations	—	—	—	—	—	—	—
Blood potassium decreased	Investigations	—	—	—	—	—	—	—
Blood potassium increased	Investigations	—	—	—	—	—	—	—
Blood sodium decreased	Investigations	—	—	—	—	—	—	—
Blood sodium increased	Investigations	—	—	—	—	—	—	—
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—	—

Data from ClinicalTrials.gov NCT04208321 adverse events section.

Sponsor's own description

This is a Phase 1, randomized, double-blind, placebo-controlled, single ascending dose study in healthy adult subjects ages 18 - 45 years inclusive. It is designed to evaluate the safety and PK of single oral doses of VT-1598. Forty-eight subjects will be enrolled in the study at 1 site in the US and randomized to receive either VT-1598 or placebo in 6 dosage cohorts (five fasted cohorts and one fed cohort). Each cohort will have 8 subjects; 6 subjects will receive a single oral dose of VT-1598 and 2 subjects will receive matching placebo. Cohorts 1 - 5 will include 2 sentinel subjects randomized to different treatments. Cohort 6 (receiving treatment after being fed a high-calorie, high-fat meal) will not include sentinel subjects. Subjects will be admitted to the study site before dosing and remain at the study site for safety monitoring and PK assessments for at least 72 hours post-dose. Subjects will return to the study site on study Days 7, 14, and 21 for outpatient safety monitoring and PK assessments. There are no formal hypotheses being tested in this Phase 1 trial study. The primary objectives of this study are 1) to determine the safety of single-ascending oral doses of VT-1598 in healthy adult subjects in a fasted state, and 2) to determine the safety of single oral dose of VT-1598 in healthy adult subjects in a fed state.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

The potential role and mechanism of circRNA/miRNA axis in cholesterol synthesis.
Chen W, Xu J, Wu Y, Liang B, et al · · 2023 · cited 66× · PMID 37324939 · DOI 10.7150/ijbs.84994
Advancements and challenges in antifungal therapeutic development.
Puumala E, Fallah S, Robbins N, Cowen LE. · · 2024 · cited 62× · PMID 38294218 · DOI 10.1128/cmr.00142-23
Advances in Antifungal Drug Development: An Up-To-Date Mini Review.
Bouz G, Doležal M. · · 2021 · cited 59× · PMID 34959712 · DOI 10.3390/ph14121312
New Approaches for Cryptococcosis Treatment.
Spadari CC, Wirth F, Lopes LB, Ishida K. · · 2020 · cited 45× · PMID 32340403 · DOI 10.3390/microorganisms8040613
New Antifungal Agents with Azole Moieties.
Teixeira MM, Carvalho DT, Sousa E, Pinto E. · · 2022 · cited 44× · PMID 36422557 · DOI 10.3390/ph15111427
Promising Drug Candidates and New Strategies for Fighting against the Emerging Superbug <i>Candida auris</i>.
Billamboz M, Fatima Z, Hameed S, Jawhara S. · · 2021 · cited 39× · PMID 33803604 · DOI 10.3390/microorganisms9030634
Novel antifungal agents in clinical trials.
Jacobs SE, Zagaliotis P, Walsh TJ. · · 2021 · cited 34× · PMID 35136573 · DOI 10.12688/f1000research.28327.2
Investigational Agents for the Treatment of Resistant Yeasts and Molds.
Seiler GT, Ostrosky-Zeichner L. · · 2021 · cited 23× · PMID 34075318 · DOI 10.1007/s12281-021-00419-5

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Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04208321 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Institute of Allergy and Infectious Diseases (NIAID)
Last refreshed: 26 July 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04208321.

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NCT04208321

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