Who is sponsoring NCT03203564?

NCT03203564 is sponsored by Isofol Medical AB.

What drugs are being tested in NCT03203564?

Interventions in NCT03203564: Modufolin (arfolitixorin).

What condition does NCT03203564 study?

NCT03203564 studies Phase I Study in Healthy Volunteers to Evaluate ECG Effect.

Is NCT03203564 still recruiting?

NCT03203564 is currently completed. Last updated 25 September 2020.

Are results published for NCT03203564?

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

Last reviewed 2020-09-25 · How we verify

NCT03203564

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

Study Evaluating ECG Effects, Safety, Tolerability and Pharmacokinetics of Single Doses of Modufolin (Arfolitixorin) in Healthy Volunteers Tetrahydrofolate in Healthy Male Volunteers

Completed Phase 1 Results posted Last updated 25 September 2020

What this trial tests

Phase 1 trial testing Modufolin (arfolitixorin) in Phase I Study in Healthy Volunteers to Evaluate ECG Effect in 33 participants. Completed in 25 August 2017.

Timeline

4 July 2017

Primary endpoint
25 August 2017

25 August 2017

Quick facts

Lead sponsor	Isofol Medical AB
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	triple
Primary purpose	other
Enrollment	33
Start date	4 July 2017
Primary completion	25 August 2017
Estimated completion	25 August 2017
Sites	1 location across Sweden

Drugs / interventions tested

Modufolin (arfolitixorin) — full drug profile →

Conditions studied

Phase I Study in Healthy Volunteers to Evaluate ECG Effect — all drugs for Phase I Study in Healthy Volunteers to Evaluate ECG Effect →

Sponsor

Isofol Medical AB — full company profile →

Who can join

Adults 18 to 60, male only, with Phase I Study in Healthy Volunteers to Evaluate ECG Effect. 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.

Change-from-baseline QTcF (ΔQTcF) Primary · Pre-dose at following timepoints -2 h, -45 min, -30 min, -15 min. Then at following timepoints; 0, 5 min, 15 min, 30 min, 1 h, 2h, 3h, 4h, 5h, 6h, 8h, 12h and 24h post-dose.

At each nominal time point specified in the CSP, up to 10 ECG replicates were extracted with TQT Plus methods. TQT Plus ECG extraction technique: Twelve-lead ECGs were extracted from continuous recordings (Holter recordings) prior to and serially after IMP administration at time points as shown in the Schedule of events. Subjects were supinely resting for at least 10 min prior to time points for ECG recordings. The 12-lead Holter and ECG equipment were supplied and supported by iCardiac Technologies, Inc. For all ECG parameters, baseline is defined as the average of the measured ECG interval

End of infusion

Group	Value	95% CI
200 mg/m2 of Modufolin®	2.8	± 2.85
350 mg/m2 of Modufolin®	9.2	± 2.84
500 mg/m2 of Modufolin®	8.5	± 2.87
Placebo	1.1	± 2.69

5 min post-dose

Group	Value	95% CI
200 mg/m2 of Modufolin®	11.2	± 2.28
350 mg/m2 of Modufolin®	9.1	± 2.28
500 mg/m2 of Modufolin®	22.4	± 2.31
Placebo	0.0	± 2.16

15 min post-dose

Group	Value	95% CI
200 mg/m2 of Modufolin®	3.1	± 1.48
350 mg/m2 of Modufolin®	7.5	± 1.47
500 mg/m2 of Modufolin®	12.4	± 1.51
Placebo	0.2	± 1.40

30 min post-dose

Group	Value	95% CI
200 mg/m2 of Modufolin®	1.2	± 1.43
350 mg/m2 of Modufolin®	2.5	± 1.42
500 mg/m2 of Modufolin®	4.2	± 1.47
Placebo	0.8	± 1.36

1 h post-dose

Group	Value	95% CI
200 mg/m2 of Modufolin®	-1.2	± 1.38
350 mg/m2 of Modufolin®	-0.7	± 1.38
500 mg/m2 of Modufolin®	-0.9	± 1.42
Placebo	1.4	± 1.32

2 h post-dose

Group	Value	95% CI
200 mg/m2 of Modufolin®	-3.5	± 1.97
350 mg/m2 of Modufolin®	-1.7	± 1.96
500 mg/m2 of Modufolin®	1.0	± 1.99
Placebo	0.7	± 1.86

3 h post-dose

Group	Value	95% CI
200 mg/m2 of Modufolin®	-2.8	± 2.58
350 mg/m2 of Modufolin®	-0.8	± 2.58
500 mg/m2 of Modufolin®	0.9	± 2.60
Placebo	3.8	± 2.44

4 h post-dose

Group	Value	95% CI
200 mg/m2 of Modufolin®	-3.3	± 2.70
350 mg/m2 of Modufolin®	0.7	± 2.70
500 mg/m2 of Modufolin®	0.0	± 2.72
Placebo	2.6	± 2.55

Relationship Between ΔΔQTc and Modufolin® (and Metabolites) Plasma Concentrations Secondary · 5 minute post-dose time point

Predicted ΔΔQTcF interval at geometric mean Cmax for 5,10-MTHF, THF, and 5-Formyl-THF and geometric mean concentration of 5-Methyl-THF observed at 5 minutes post-dose The relationship between plasma concentrations of 5,10-MTHF, THF, 5-Methyl-THF, and 5-Formyl-THF, and change-from-baseline QTcF (ΔQTcF) was quantified using a linear mixed-effects modeling approach with separate analyses for each of the analytes (5,10-MTHF, THF 5-Methyl-THF, and 5-Formyl-THF) initially, with ΔQTcF as the dependent variable, plasma concentration of 5,10-MTHF (or THF, 5-Methyl-THF, or 5-Formyl-THF) as a continuous

5,10-MTHF

Group	Value	95% CI
200 mg/m2 of Modufolin®	24111.78	19194.04 – 30289.52
350 mg/m2 of Modufolin®	51566.94	46351.78 – 57368.87
500 mg/m2 of Modufolin®	69012.28	60609.82 – 78579.59

THF

Group	Value	95% CI
200 mg/m2 of Modufolin®	15995.29	13750.28 – 18606.83
350 mg/m2 of Modufolin®	29386.77	26812.58 – 32208.09
500 mg/m2 of Modufolin®	44018.37	40400.31 – 47960.44

5-Methyl-THF

Group	Value	95% CI
200 mg/m2 of Modufolin®	218.18	176.04 – 270.40
350 mg/m2 of Modufolin®	544.01	435.70 – 679.25
500 mg/m2 of Modufolin®	333.09	279.56 – 396.86

5-Formyl-THF

Group	Value	95% CI
200 mg/m2 of Modufolin®	296.43	114.76 – 765.71
350 mg/m2 of Modufolin®	567.17	414.42 – 776.22
500 mg/m2 of Modufolin®	379.33	333.23 – 431.81

ΔΔQTcF

Group	Value	95% CI
200 mg/m2 of Modufolin®	4.15	0.97 – 7.33
350 mg/m2 of Modufolin®	13.25	9.36 – 17.14
500 mg/m2 of Modufolin®	19.88	15.40 – 24.35

Change-from-baseline Heart Rate (ΔHR) Secondary · Pre-dose at following timepoints -2 h, -45 min, -30 min, -15 min. Then at following timepoints; 0, 5 min, 15 min, 30 min, 1 h, 2h, 3h, 4h, 5h, 6h, 8h, 12h and 24h post-dose.

The analysis was based on the change-from-baseline post-dosing values. The same (by-time point analysis) model was used as described for QTcF. For all ECG parameters, baseline is defined as the average of the measured ECG intervals from the three pre-dose time points (45, 30, and 15 min predose) on Day 1.

End of infusion

Group	Value	95% CI
200 mg/m2 of Modufolin®	2.6	± 1.91
350 mg/m2 of Modufolin®	2.7	± 1.91
500 mg/m2 of Modufolin®	2.0	± 1.92
Placebo	-2.1	± 1.80

5 min post-dose

Group	Value	95% CI
200 mg/m2 of Modufolin®	8.2	± 2.56
350 mg/m2 of Modufolin®	7.4	± 2.55
500 mg/m2 of Modufolin®	13.3	± 2.56
Placebo	0.0	± 2.41

15 min post-dose

Group	Value	95% CI
200 mg/m2 of Modufolin®	3.9	± 1.63
350 mg/m2 of Modufolin®	3.6	± 1.63
500 mg/m2 of Modufolin®	2.6	± 1.64
Placebo	-1.6	± 1.53

30 min post-dose

Group	Value	95% CI
200 mg/m2 of Modufolin®	3.3	± 2.00
350 mg/m2 of Modufolin®	1.3	± 2.00
500 mg/m2 of Modufolin®	3.0	± 2.00
Placebo	-0.7	± 1.88

1 h post-dose

Group	Value	95% CI
200 mg/m2 of Modufolin®	5.0	± 1.90
350 mg/m2 of Modufolin®	0.0	± 1.90
500 mg/m2 of Modufolin®	-0.9	± 1.91
Placebo	-1.3	± 1.79

2 h post-dose

Group	Value	95% CI
200 mg/m2 of Modufolin®	3.2	± 1.52
350 mg/m2 of Modufolin®	-0.1	± 1.52
500 mg/m2 of Modufolin®	-2.6	± 1.53
Placebo	-1.8	± 1.43

3 h post-dose

Group	Value	95% CI
200 mg/m2 of Modufolin®	2.2	± 1.47
350 mg/m2 of Modufolin®	0.3	± 1.46
500 mg/m2 of Modufolin®	0.3	± 1.47
Placebo	-2.3	± 1.38

4 h post-dose

Group	Value	95% CI
200 mg/m2 of Modufolin®	1.7	± 1.82
350 mg/m2 of Modufolin®	2.0	± 1.82
500 mg/m2 of Modufolin®	0.2	± 1.83
Placebo	-3.3	± 1.72

Change-from-baseline PR (ΔPR) Secondary · Pre-dose at following timepoints -2 h, -45 min, -30 min, -15 min. Then at following timepoints; 0, 5 min, 15 min, 30 min, 1 h, 2h, 3h, 4h, 5h, 6h, 8h, 12h and 24h post-dose.

End of infusion

Group	Value	95% CI
200 mg/m2 of Modufolin®	-1.6	± 2.08
350 mg/m2 of Modufolin®	-4.4	± 2.08
500 mg/m2 of Modufolin®	-2.1	± 2.08
Placebo	-1.6	± 1.96

5 min post-dose

Group	Value	95% CI
200 mg/m2 of Modufolin®	-1.5	± 2.07
350 mg/m2 of Modufolin®	-4.5	± 2.07
500 mg/m2 of Modufolin®	-3.1	± 2.07
Placebo	-0.1	± 1.96

15 min post-dose

Group	Value	95% CI
200 mg/m2 of Modufolin®	-2.3	± 2.61
350 mg/m2 of Modufolin®	-1.2	± 2.61
500 mg/m2 of Modufolin®	0.2	± 2.61
Placebo	3.8	± 2.46

30 min post-dose

Group	Value	95% CI
200 mg/m2 of Modufolin®	-1.7	± 2.11
350 mg/m2 of Modufolin®	-3.7	± 2.11
500 mg/m2 of Modufolin®	1.3	± 2.11
Placebo	2.9	± 1.99

1 h post-dose

Group	Value	95% CI
200 mg/m2 of Modufolin®	-5.2	± 1.89
350 mg/m2 of Modufolin®	-3.6	± 1.89
500 mg/m2 of Modufolin®	-0.3	± 1.89
Placebo	0.4	± 1.79

2 h post-dose

Group	Value	95% CI
200 mg/m2 of Modufolin®	-4.1	± 2.13
350 mg/m2 of Modufolin®	-4.1	± 2.13
500 mg/m2 of Modufolin®	1.1	± 2.13
Placebo	3.1	± 2.01

3 h post-dose

Group	Value	95% CI
200 mg/m2 of Modufolin®	-5.3	± 2.14
350 mg/m2 of Modufolin®	-4.2	± 2.14
500 mg/m2 of Modufolin®	-1.6	± 2.14
Placebo	1.2	± 2.02

4 h post-dose

Group	Value	95% CI
200 mg/m2 of Modufolin®	-5.2	± 1.84
350 mg/m2 of Modufolin®	-4.6	± 1.84
500 mg/m2 of Modufolin®	-2.1	± 1.84
Placebo	1.4	± 1.74

Change-from-baseline QRS (ΔQRS) Secondary · Pre-dose at following timepoints -2 h, -45 min, -30 min, -15 min. Then at following timepoints; 0, 5 min, 15 min, 30 min, 1 h, 2h, 3h, 4h, 5h, 6h, 8h, 12h and 24h post-dose.

End of infusion

Group	Value	95% CI
200 mg/m2 of Modufolin®	-0.1	± 0.27
350 mg/m2 of Modufolin®	-0.2	± 0.27
500 mg/m2 of Modufolin®	-0.1	± 0.27
Placebo	0.5	± 0.25

5 min post-dose

Group	Value	95% CI
200 mg/m2 of Modufolin®	-0.7	± 0.28
350 mg/m2 of Modufolin®	-0.8	± 0.28
500 mg/m2 of Modufolin®	-1.2	± 0.28
Placebo	0.0	± 0.26

15 min post-dose

Group	Value	95% CI
200 mg/m2 of Modufolin®	-0.2	± 0.25
350 mg/m2 of Modufolin®	-0.3	± 0.25
500 mg/m2 of Modufolin®	-0.1	± 0.25
Placebo	0.0	± 0.24

30 min post-dose

Group	Value	95% CI
200 mg/m2 of Modufolin®	-0.7	± 0.27
350 mg/m2 of Modufolin®	0.0	± 0.27
500 mg/m2 of Modufolin®	-0.5	± 0.27
Placebo	0.0	± 0.26

1 h post-dose

Group	Value	95% CI
200 mg/m2 of Modufolin®	-0.2	± 0.26
350 mg/m2 of Modufolin®	0.1	± 0.26
500 mg/m2 of Modufolin®	0.2	± 0.26
Placebo	0.0	± 0.24

2 h post-dose

Group	Value	95% CI
200 mg/m2 of Modufolin®	-0.2	± 0.22
350 mg/m2 of Modufolin®	0.0	± 0.22
500 mg/m2 of Modufolin®	-0.1	± 0.22
Placebo	-0.1	± 0.21

3 h post-dose

Group	Value	95% CI
200 mg/m2 of Modufolin®	0.0	± 0.30
350 mg/m2 of Modufolin®	-0.1	± 0.31
500 mg/m2 of Modufolin®	-0.4	± 0.30
Placebo	0.2	± 0.29

4 h post-dose

Group	Value	95% CI
200 mg/m2 of Modufolin®	0.1	± 0.39
350 mg/m2 of Modufolin®	-0.5	± 0.39
500 mg/m2 of Modufolin®	0.2	± 0.38
Placebo	0.9	± 0.36

Number of Participants With Categorical QTcF Outliers Secondary · Pre-dose at following timepoints -2 h, -45 min, -30 min, -15 min. Then at following timepoints; 0, 5 min, 15 min, 30 min, 1 h, 2h, 3h, 4h, 5h, 6h, 8h, 12h and 24h post-dose.

QTcF outliers per absolute category across treatment groups and QTcF outliers per change-from-baseline category (ΔQTcF)

No. participants with QTcF > 450 and ≤ 480 msec

Group	Value	95% CI
200 mg/m2 of Modufolin®	0
350 mg/m2 of Modufolin®	0
500 mg/m2 of Modufolin®	1
Placebo	0

No. participants with QTcF > 480 and ≤ 500 msec

Group	Value	95% CI
200 mg/m2 of Modufolin®	0
350 mg/m2 of Modufolin®	0
500 mg/m2 of Modufolin®	0
Placebo	0

No. participants with QTcF > 500 msec

Group	Value	95% CI
200 mg/m2 of Modufolin®	0
350 mg/m2 of Modufolin®	0
500 mg/m2 of Modufolin®	0
Placebo	0

No. participants with ΔQTcF of > 30 and ≤ 60 msec

Group	Value	95% CI
200 mg/m2 of Modufolin®	0
350 mg/m2 of Modufolin®	0
500 mg/m2 of Modufolin®	2
Placebo	0

No. participants with ΔQTcF > 60 msec

Group	Value	95% CI
200 mg/m2 of Modufolin®	0
350 mg/m2 of Modufolin®	0
500 mg/m2 of Modufolin®	0
Placebo	0

Categorical Outliers for HR, PR Interval, QRS Interval Secondary · Pre-dose at following timepoints -2 h, -45 min, -30 min, -15 min. Then at following timepoints; 0, 5 min, 15 min, 30 min, 1 h, 2h, 3h, 4h, 5h, 6h, 8h, 12h and 24h post-dose.

Categorical Analysis of outliers for HR, PR, and QRS intervals

HR changes >25% decrease from baseline to <50 bpm

Group	Value	95% CI
200 mg/m2 of Modufolin®	0
350 mg/m2 of Modufolin®	0
500 mg/m2 of Modufolin®	0
Placebo	0

HR changes >25% increase from baseline to >100bpm

Group	Value	95% CI
200 mg/m2 of Modufolin®	0
350 mg/m2 of Modufolin®	0
500 mg/m2 of Modufolin®	0
Placebo	0

PR changes > 25% increase from baseline to >200ms

Group	Value	95% CI
200 mg/m2 of Modufolin®	0
350 mg/m2 of Modufolin®	0
500 mg/m2 of Modufolin®	0
Placebo	0

QRS changes > 25% increase from baseline to >120ms

Group	Value	95% CI
200 mg/m2 of Modufolin®	0
350 mg/m2 of Modufolin®	0
500 mg/m2 of Modufolin®	0
Placebo	0

Categorical Analysis for T Wave Morphology Secondary · Pre-dose at following timepoints -2 h, -45 min, -30 min, -15 min. Then at following timepoints; 0, 5 min, 15 min, 30 min, 1 h, 2h, 3h, 4h, 5h, 6h, 8h, 12h and 24h post-dose.

Categorical T-wave morphology analysis and measurement of PR and QRS intervals were fully performed manually in three of the 10 ECG replicates at each time point. Final quality control and diagnostic interpretations were performed by the study cardiologist. When the results for each time point were compiled in the final data set, the comparison was made between ECG parameters from the three manually reviewed ECGs versus the 10 ECG replicates for quality control purposes. No treatment emergent T wave morphology changes were observed. In addition to the T-wave categorical analysis, the presence

Flat

Group	Value	95% CI
200 mg/m2 of Modufolin®	0
350 mg/m2 of Modufolin®	0
500 mg/m2 of Modufolin®	0
Placebo	0

Notched (+)

Group	Value	95% CI
200 mg/m2 of Modufolin®	0
350 mg/m2 of Modufolin®	0
500 mg/m2 of Modufolin®	0
Placebo	0

Biphasic

Group	Value	95% CI
200 mg/m2 of Modufolin®	0
350 mg/m2 of Modufolin®	0
500 mg/m2 of Modufolin®	0
Placebo	0

Normal (-)

Group	Value	95% CI
200 mg/m2 of Modufolin®	0
350 mg/m2 of Modufolin®	0
500 mg/m2 of Modufolin®	0
Placebo	0

Notched (-)

Group	Value	95% CI
200 mg/m2 of Modufolin®	0
350 mg/m2 of Modufolin®	0
500 mg/m2 of Modufolin®	0
Placebo	0

U wave presence

Group	Value	95% CI
200 mg/m2 of Modufolin®	0
350 mg/m2 of Modufolin®	0
500 mg/m2 of Modufolin®	0
Placebo	0

Physical Examination Secondary · At visit 1 (screening) and follow-up

A complete physical examination included assessments of the head, eyes, ears, nose, throat, skin, thyroid, neurological, lungs, cardiovascular, abdomen (liver and spleen), lymph nodes and extremities. Physical examination findings were categorized as Normal, Abnormal non-clinical significant (NCS), and Abnormal clinical significant (CS).

Abnormal NCS - Visit 1

Group	Value	95% CI
200 mg/m2 of Modufolin®	0
350 mg/m2 of Modufolin®	0
500 mg/m2 of Modufolin®	1
Placebo	0

Abnormal CS - Visit 1

Group	Value	95% CI
200 mg/m2 of Modufolin®	0
350 mg/m2 of Modufolin®	0
500 mg/m2 of Modufolin®	0
Placebo	0

Abnormal NCS - Follow-up

Group	Value	95% CI
200 mg/m2 of Modufolin®	0
350 mg/m2 of Modufolin®	0
500 mg/m2 of Modufolin®	0
Placebo	0

Abnormal CS - Follow-up

Group	Value	95% CI
200 mg/m2 of Modufolin®	0
350 mg/m2 of Modufolin®	0
500 mg/m2 of Modufolin®	0
Placebo	0

Systolic Blood Pressure Secondary · Predose at following timepoints: At screening (visit 1) and at -15 min (visit 2). Postdose at following timepoints: 3h, 5h, 8 h and 24h (visit 2) and at visit 3 (follow-up visit).

Systolic and diastolic BP and pulse were measured in supine position after 10 min of rest.

Screening

Group	Value	95% CI
200 mg/m2 of Modufolin®	115.50	± 7.60
350 mg/m2 of Modufolin®	121.25	± 7.07
500 mg/m2 of Modufolin®	116.63	± 9.56
Placebo	125.56	± 14.82

Visit 2 Day 1 (-00:15)

Group	Value	95% CI
200 mg/m2 of Modufolin®	111.38	± 10.94
350 mg/m2 of Modufolin®	109.38	± 9.36
500 mg/m2 of Modufolin®	117.38	± 8.11
Placebo	123.67	± 24.63

Visit 2 Day 1 (03:00)

Group	Value	95% CI
200 mg/m2 of Modufolin®	108.88	± 7.12
350 mg/m2 of Modufolin®	105.00	± 6.89
500 mg/m2 of Modufolin®	112.50	± 9.29
Placebo	111.22	± 7.87

Visit 2 Day 1 (05:00)

Group	Value	95% CI
200 mg/m2 of Modufolin®	115.50	± 5.61
350 mg/m2 of Modufolin®	115.00	± 8.50
500 mg/m2 of Modufolin®	120.88	± 7.94
Placebo	113.00	± 13.32

Visit 2 Day 1 (08:00)

Group	Value	95% CI
200 mg/m2 of Modufolin®	118.50	± 9.06
350 mg/m2 of Modufolin®	113.88	± 6.75
500 mg/m2 of Modufolin®	115.63	± 5.83
Placebo	114.89	± 10.61

Visit 2 Day 2

Group	Value	95% CI
200 mg/m2 of Modufolin®	117.75	± 9.29
350 mg/m2 of Modufolin®	114.13	± 5.77
500 mg/m2 of Modufolin®	120.88	± 8.46
Placebo	119.00	± 10.02

Follow-up

Group	Value	95% CI
200 mg/m2 of Modufolin®	121.38	± 8.93
350 mg/m2 of Modufolin®	115.63	± 11.03
500 mg/m2 of Modufolin®	119.38	± 10.21
Placebo	122.11	± 12.24

Diastolic Blood Pressure Secondary · Predose at following timepoints: At screening (visit 1) and at -15 min (visit 2). Postdose at following timepoints: 3h, 5h, 8 h and 24h (visit 2) and at visit 3 (follow-up visit).

Systolic and diastolic BP and pulse were measured in supine position after 10 min of rest. There were no clinically relevant mean changes over time or any individual changes assessed as clinically significant with regards to any of the vital signs parameters.

Screening

Group	Value	95% CI
200 mg/m2 of Modufolin®	68.63	± 5.21
350 mg/m2 of Modufolin®	69.75	± 8.51
500 mg/m2 of Modufolin®	72.25	± 8.01
Placebo	73.56	± 11.75

Visit 2 Day 1 (-00:15)

Group	Value	95% CI
200 mg/m2 of Modufolin®	69.63	± 3.74
350 mg/m2 of Modufolin®	65.88	± 6.42
500 mg/m2 of Modufolin®	75.38	± 2.77
Placebo	69.56	± 9.06

Visit 2 Day 1 (03:00)

Group	Value	95% CI
200 mg/m2 of Modufolin®	69.00	± 6.89
350 mg/m2 of Modufolin®	64.38	± 7.37
500 mg/m2 of Modufolin®	72.63	± 5.71
Placebo	65.56	± 11.20

Visit 2 Day 1 (05:00)

Group	Value	95% CI
200 mg/m2 of Modufolin®	65.63	± 5.88
350 mg/m2 of Modufolin®	62.38	± 5.04
500 mg/m2 of Modufolin®	72.25	± 7.15
Placebo	67.00	± 11.16

Visit 2 Day 1 (08:00)

Group	Value	95% CI
200 mg/m2 of Modufolin®	69.00	± 7.29
350 mg/m2 of Modufolin®	64.50	± 3.89
500 mg/m2 of Modufolin®	70.25	± 6.36
Placebo	66.22	± 9.59

Visit 2 Day 2

Group	Value	95% CI
200 mg/m2 of Modufolin®	71.50	± 10.23
350 mg/m2 of Modufolin®	69.38	± 4.50
500 mg/m2 of Modufolin®	74.25	± 5.47
Placebo	71.11	± 8.15

Follow-up

Group	Value	95% CI
200 mg/m2 of Modufolin®	68.25	± 4.53
350 mg/m2 of Modufolin®	70.25	± 7.81
500 mg/m2 of Modufolin®	71.00	± 8.07
Placebo	70.11	± 7.99

Vital Signs: Pulse Secondary · Predose at following timepoints: At screening (visit 1) and at -15 min (visit 2). Postdose at following timepoints: 3h, 5h, 8 h and 24h (visit 2) and at visit 3 (follow-up visit).

Screening

Group	Value	95% CI
200 mg/m2 of Modufolin®	59.50	± 5.21
350 mg/m2 of Modufolin®	66.50	± 9.38
500 mg/m2 of Modufolin®	62.00	± 11.24
Placebo	63.22	± 12.88

Visit 2 Day 1 (-00:15)

Group	Value	95% CI
200 mg/m2 of Modufolin®	55.25	± 5.44
350 mg/m2 of Modufolin®	52.00	± 8.60
500 mg/m2 of Modufolin®	56.38	± 5.58
Placebo	54.44	± 11.34

Visit 2 Day 1 03:00)

Group	Value	95% CI
200 mg/m2 of Modufolin®	56.25	± 5.50
350 mg/m2 of Modufolin®	53.13	± 11.01
500 mg/m2 of Modufolin®	53.75	± 4.95
Placebo	50.33	± 6.60

Visit 2 Day 1 (05:00)

Group	Value	95% CI
200 mg/m2 of Modufolin®	65.38	± 4.00
350 mg/m2 of Modufolin®	65.25	± 9.66
500 mg/m2 of Modufolin®	66.00	± 11.60
Placebo	61.44	± 8.92

Visit 2 Day 1 (08:00)

Group	Value	95% CI
200 mg/m2 of Modufolin®	60.25	± 6.82
350 mg/m2 of Modufolin®	59.00	± 5.83
500 mg/m2 of Modufolin®	56.75	± 7.21
Placebo	55.67	± 7.23

Visit 2 Day 2

Group	Value	95% CI
200 mg/m2 of Modufolin®	59.38	± 9.53
350 mg/m2 of Modufolin®	57.63	± 8.91
500 mg/m2 of Modufolin®	61.75	± 13.48
Placebo	61.22	± 11.31

Follow-up

Group	Value	95% CI
200 mg/m2 of Modufolin®	66.25	± 9.04
350 mg/m2 of Modufolin®	67.88	± 12.91
500 mg/m2 of Modufolin®	69.25	± 16.26
Placebo	67.44	± 14.47

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event data was collected from start of IMP administration to last subject last visit, thus during a period of little less than 2 months.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

200 mg/m2 of Modufolin®

Serious: 0/8 (0%)

Deaths: 0/8

350 mg/m2 of Modufolin®

Serious: 0/8 (0%)

Deaths: 0/8

500 mg/m2 of Modufolin®

Serious: 0/8 (0%)

Deaths: 0/8

Placebo

Serious: 0/9 (0%)

Deaths: 0/9

Other adverse events (16 terms — click to expand)

Reaction	System	200 mg/m2 of Modufolin®	350 mg/m2 of Modufolin®	500 mg/m2 of Modufolin®	Placebo
Nausea	Gastrointestinal disorders	—	—	—	—
Nasal congestion	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Dysgeusia	Nervous system disorders	—	—	—	—
Paraesthesia	Nervous system disorders	—	—	—	—
Paraesthesia oral	Nervous system disorders	—	—	—	—
Sneezing	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Headache	Nervous system disorders	—	—	—	—
Hypoaesthesia	Nervous system disorders	—	—	—	—
Hypoaesthesia oral	Nervous system disorders	—	—	—	—
Chills	General disorders	—	—	—	—
Fatigue	General disorders	—	—	—	—
Flushing	General disorders	—	—	—	—
Injection site pain	General disorders	—	—	—	—
Pain	General disorders	—	—	—	—
Dysgeusia	Gastrointestinal disorders	—	—	—	—
Paraesthesia oral	Gastrointestinal disorders	—	—	—	—

Data from ClinicalTrials.gov NCT03203564 adverse events section.

Sponsor's own description

The purpose of this study is to evaluating ECG effects, safety, tolerability and pharmacokinetics of single ascending dose of Modufolin® in healthy male volunteers

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03203564 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Isofol Medical AB
Last refreshed: 25 September 2020

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/NCT03203564.

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NCT03203564

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other Isofol Medical AB trials

Verify against primary sources