Who is sponsoring NCT03575962?

NCT03575962 is sponsored by ViiV Healthcare.

What drugs are being tested in NCT03575962?

Interventions in NCT03575962: GSK3640254 bis-hydrochloride salt capsule, GSK3640254 Mesylate Salt Capsule.

What condition does NCT03575962 study?

NCT03575962 studies HIV Infections.

Is NCT03575962 still recruiting?

NCT03575962 is currently completed. Last updated 6 September 2019.

Are results published for NCT03575962?

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

Last reviewed 2019-09-06 · How we verify

NCT03575962

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

A Study to Compare the Relative Bioavailability of Two Different Formulations of GSK3640254

Completed Phase 1 Results posted Last updated 6 September 2019

What this trial tests

Phase 1 trial testing GSK3640254 bis-hydrochloride salt capsule in HIV Infections in 14 participants. Completed in 6 August 2018.

Timeline

18 June 2018

Primary endpoint
6 August 2018

6 August 2018

Quick facts

Lead sponsor	ViiV Healthcare
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	14
Start date	18 June 2018
Primary completion	6 August 2018
Estimated completion	6 August 2018
Sites	1 location across United Kingdom

Drugs / interventions tested

GSK3640254 bis-hydrochloride salt capsule — full drug profile →
GSK3640254 Mesylate Salt Capsule — full drug profile →

Conditions studied

HIV Infections — all drugs for HIV Infections →

Sponsor

ViiV Healthcare — full company profile →

Who can join

Adults 18 to 55, any sex, with HIV Infections. 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.

Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC[0-infinity]) of GSK3640254 Following Single Oral Dose in Healthy Participants Primary · Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 and 72 hours post-dose in each treatment period

Blood samples were collected at designated timepoints. Pharmacokinetic (PK) parameters of GSK3640254 were calculated using non-compartmental methods. Geometric mean and percentage (%) geometric coefficient of variation have been presented.

Group	Value	95% CI
GSK3640254 200 mg Hydrochloride Salt	23.5666	± 27.2
GSK3640254 Capsule 200 mg Mesylate Salt	27.6204	± 46.7

Area Under the Concentration-time Curve From Zero to Time of Last Sample Taken (AUC[0-t]) of GSK3640254 Following Single Oral Dose in Healthy Participants Primary · Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, and 72 hours post-dose in each treatment period

Blood samples were collected at designated timepoints. PK parameters of GSK3640254 were calculated using non-compartmental methods. Geometric mean and % geometric coefficient of variation have been presented. Statistical analysis of PK parameters was done using mixed effect model for evaluation of relative bioavailability (Frel). Point estimate and 90% confidence interval (CI) for the ratio of geometric least square mean of the test mesylate salt capsule to the reference Hydrochloride capsule were calculated for AUC(0-t).

Group	Value	95% CI
GSK3640254 200 mg Hydrochloride Salt	20.2797	± 32.9
GSK3640254 Capsule 200 mg Mesylate Salt	22.6494	± 40.1

Maximum Observed Concentration (Cmax) of GSK3640254 Following Single Oral Dose in Healthy Participants Primary · Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, and 72 hours post-dose in each treatment period

Blood samples were collected at designated timepoints. PK parameters of GSK3640254 were calculated using non-compartmental methods. Geometric mean and % geometric coefficient of variation have been presented. Statistical analysis of PK parameters was done using mixed effect model for evaluation of Frel. Point estimate and 90% CI for the ratio of geometric least square mean of the test mesylate salt capsule to the reference Hydrochloride capsule were calculated for Cmax.

Group	Value	95% CI
GSK3640254 200 mg Hydrochloride Salt	0.7357	± 35.7
GSK3640254 Capsule 200 mg Mesylate Salt	0.8502	± 40.5

Time to Reach Maximum Observed Concentration (Tmax) of GSK3640254 Following Single Oral Dose in Healthy Participants Primary · Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, and 72 hours post-dose in each treatment period

Blood samples were collected at designated timepoints. PK parameters of GSK3640254 were calculated using non-compartmental methods. Median and full range of Tmax have been presented.

Group	Value	95% CI
GSK3640254 200 mg Hydrochloride Salt	5.0	2 – 6
GSK3640254 Capsule 200 mg Mesylate Salt	5.0	2 – 6

Concentration at 24 Hours Post-dose (C24h) of GSK3640254 Following Single Oral Dose in Healthy Participants Primary · Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose in each treatment period

Group	Value	95% CI
GSK3640254 200 mg Hydrochloride Salt	0.3439	± 37.9
GSK3640254 Capsule 200 mg Mesylate Salt	0.3855	± 45.2

Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs) Secondary · Up to 25 days

An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect and other situations according to medical or scientific judgement.

Any non-SAEs

Group	Value	95% CI
GSK3640254 200 mg Hydrochloride Salt	4
GSK3640254 Capsule 200 mg Mesylate Salt	6

Any SAEs

Group	Value	95% CI
GSK3640254 200 mg Hydrochloride Salt	0
GSK3640254 Capsule 200 mg Mesylate Salt	0

Change From Baseline in Clinical Chemistry Parameters; Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) Secondary · Baseline (Day -1) and Day 3

Blood samples were collected to analyze the clinical chemistry parameters; ALT, ALP and AST. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the post-Dose visit value. Mean and standard deviation have been presented.

ALT, Day 3, n=14,14

Group	Value	95% CI
GSK3640254 200 mg Hydrochloride Salt	-1.9	± 4.51
GSK3640254 Capsule 200 mg Mesylate Salt	2.3	± 6.84

ALP, Day 3, n=14,14

Group	Value	95% CI
GSK3640254 200 mg Hydrochloride Salt	-1.2	± 7.27
GSK3640254 Capsule 200 mg Mesylate Salt	3.0	± 5.87

AST, Day 3, n=13,14

Group	Value	95% CI
GSK3640254 200 mg Hydrochloride Salt	-3.5	± 3.82
GSK3640254 Capsule 200 mg Mesylate Salt	-2.9	± 6.55

Change From Baseline in Clinical Chemistry Parameters; Bicarbonate, Calcium, Chloride, Glucose (Fasting), Potassium, Sodium and Urea Secondary · Baseline (Day -1) and Day 3

Blood samples were collected to analyze the clinical chemistry parameters; Bicarbonate, Calcium, Chloride, Glucose (fasting), Potassium, Sodium and Urea. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the post-Dose visit value. Mean and standard deviation have been presented.

Bicarbonate, Day 3, n=14,14

Group	Value	95% CI
GSK3640254 200 mg Hydrochloride Salt	-3.0	± 2.66
GSK3640254 Capsule 200 mg Mesylate Salt	-2.6	± 2.31

Calcium, Day 3, n=14,14

Group	Value	95% CI
GSK3640254 200 mg Hydrochloride Salt	-0.044	± 0.1019
GSK3640254 Capsule 200 mg Mesylate Salt	0.033	± 0.0961

Chloride, Day 3, n=14,14

Group	Value	95% CI
GSK3640254 200 mg Hydrochloride Salt	-0.5	± 1.61
GSK3640254 Capsule 200 mg Mesylate Salt	-1.7	± 1.94

Glucose (fasting), Day 3, n=12,14

Group	Value	95% CI
GSK3640254 200 mg Hydrochloride Salt	-0.17	± 0.444
GSK3640254 Capsule 200 mg Mesylate Salt	0.04	± 0.554

Potassium, Day 3, n=14,14

Group	Value	95% CI
GSK3640254 200 mg Hydrochloride Salt	0.21	± 0.435
GSK3640254 Capsule 200 mg Mesylate Salt	0.06	± 0.445

Sodium, Day 3, n=14,14

Group	Value	95% CI
GSK3640254 200 mg Hydrochloride Salt	-0.9	± 1.10
GSK3640254 Capsule 200 mg Mesylate Salt	-1.1	± 1.56

Urea, Day 3, n=14,14

Group	Value	95% CI
GSK3640254 200 mg Hydrochloride Salt	-0.41	± 1.634
GSK3640254 Capsule 200 mg Mesylate Salt	-0.39	± 0.849

Change From Baseline in Clinical Chemistry Parameters; Bilirubin, Creatinine and Direct Bilirubin Secondary · Baseline (Day -1) and Day 3

Blood samples were collected to analyze the clinical chemistry parameters; Bilirubin, Creatinine and Direct Bilirubin. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the post-Dose visit value. Mean and standard deviation have been presented.

Bilirubin, Day 3, n=14,14

Group	Value	95% CI
GSK3640254 200 mg Hydrochloride Salt	2.1	± 3.94
GSK3640254 Capsule 200 mg Mesylate Salt	-0.3	± 3.81

Creatinine, Day 3, n=14,14

Group	Value	95% CI
GSK3640254 200 mg Hydrochloride Salt	0.1	± 7.29
GSK3640254 Capsule 200 mg Mesylate Salt	-0.1	± 5.74

Direct Bilirubin, Day 3, n=0,1

Group	Value	95% CI
GSK3640254 Capsule 200 mg Mesylate Salt	-1.0	± NA

Change From Baseline in Clinical Chemistry Parameter; Protein Secondary · Baseline (Day -1) and Day 3

Blood samples were collected to analyze the clinical chemistry parameter; Protein. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the post-Dose visit value. Mean and standard deviation have been presented.

Group	Value	95% CI
GSK3640254 200 mg Hydrochloride Salt	-0.5	± 3.72
GSK3640254 Capsule 200 mg Mesylate Salt	1.4	± 4.03

Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Secondary · Up to 22 days

Blood samples were collected to analyze the hematology parameters; Hematocrit (Hct), Hemoglobin (Hb), Leukocytes, Lymphocytes, Neutrophils and Platelets. PCI ranges were Hct (Male and Female \[high: \>0.54 proportion of red blood cells in blood\]), Hb (Male and Female \[high: \>180 grams per liter\]), lymphocytes (low: \<0.8x10\^9 cells per liter), neutrophils (low: \<1.5x10\^9 cells per liter), platelets (low: \<100x10\^9 cells per liter and high: \>550x10\^9 cells per liter) and leukocytes (low: \<3x10\^9 cells per liter and high: \>12x10\^9 cells per liter). Participants were counted in the

Hct, To low

Group	Value	95% CI
GSK3640254 200 mg Hydrochloride Salt	0
GSK3640254 Capsule 200 mg Mesylate Salt	0

Hct, To normal or no change

Group	Value	95% CI
GSK3640254 200 mg Hydrochloride Salt	14
GSK3640254 Capsule 200 mg Mesylate Salt	14

Hct, To high

Group	Value	95% CI
GSK3640254 200 mg Hydrochloride Salt	0
GSK3640254 Capsule 200 mg Mesylate Salt	0

Hb, To low

Group	Value	95% CI
GSK3640254 200 mg Hydrochloride Salt	0
GSK3640254 Capsule 200 mg Mesylate Salt	0

Hb, To normal or no change

Group	Value	95% CI
GSK3640254 200 mg Hydrochloride Salt	13
GSK3640254 Capsule 200 mg Mesylate Salt	14

Hb, To high

Group	Value	95% CI
GSK3640254 200 mg Hydrochloride Salt	1
GSK3640254 Capsule 200 mg Mesylate Salt	0

Leukocytes, To low

Group	Value	95% CI
GSK3640254 200 mg Hydrochloride Salt	0
GSK3640254 Capsule 200 mg Mesylate Salt	0

Leukocytes, To normal or no change

Group	Value	95% CI
GSK3640254 200 mg Hydrochloride Salt	14
GSK3640254 Capsule 200 mg Mesylate Salt	13

Number of Participants With Urinalysis Results by Dipstick Method by Visit Secondary · Day -1 and Day 3

Urine samples were collected to assess urine bilirubin, urine glucose, urine ketones, urine leukocyte esterase (LE), urine nitrite, urine occult blood, urine protein, urobilinogen and monitor urine potential of hydrogen (pH). The dipstick test gave results in a semi-quantitative manner, and results for urinalysis parameters were recorded as negative, trace and positive, indicating proportional concentrations in the urine sample. All the numeric result values \>0 have been considered as "positive".

Bilirubin, Day -1, Negative, n=14,14

Group	Value	95% CI
GSK3640254 200 mg Hydrochloride Salt	14
GSK3640254 Capsule 200 mg Mesylate Salt	14

Bilirubin, Day -1, Trace, n=14,14

Group	Value	95% CI
GSK3640254 200 mg Hydrochloride Salt	0
GSK3640254 Capsule 200 mg Mesylate Salt	0

Bilirubin, Day -1, Positive, n=14,14

Group	Value	95% CI
GSK3640254 200 mg Hydrochloride Salt	0
GSK3640254 Capsule 200 mg Mesylate Salt	0

Bilirubin, Day 3, Negative, n=14,14

Group	Value	95% CI
GSK3640254 200 mg Hydrochloride Salt	14
GSK3640254 Capsule 200 mg Mesylate Salt	14

Bilirubin, Day 3, Trace, n=14,14

Group	Value	95% CI
GSK3640254 200 mg Hydrochloride Salt	0
GSK3640254 Capsule 200 mg Mesylate Salt	0

Bilirubin, Day 3, Positive, n=14,14

Group	Value	95% CI
GSK3640254 200 mg Hydrochloride Salt	0
GSK3640254 Capsule 200 mg Mesylate Salt	0

Glucose, Day -1, Negative, n=14,14

Group	Value	95% CI
GSK3640254 200 mg Hydrochloride Salt	14
GSK3640254 Capsule 200 mg Mesylate Salt	14

Glucose, Day -1, Trace, n=14,14

Group	Value	95% CI
GSK3640254 200 mg Hydrochloride Salt	0
GSK3640254 Capsule 200 mg Mesylate Salt	0

Adverse events — posted to ClinicalTrials.gov

Time frame: SAEs and non-serious AEs were collected from the start of study treatment up to 25 days.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

GSK3640254 200 mg Hydrochloride Salt

Serious: 0/14 (0%)

Deaths: 0/14

GSK3640254 Capsule 200 mg Mesylate Salt

Serious: 0/14 (0%)

Deaths: 0/14

Other adverse events (7 terms — click to expand)

Reaction	System	GSK3640254 200 mg Hydrochl…	GSK3640254 Capsule 200 mg …
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—
Headache	Nervous system disorders	—	—
Abdominal pain	Gastrointestinal disorders	—	—
Flatulence	Gastrointestinal disorders	—	—
Gingival bleeding	Gastrointestinal disorders	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—
Epistaxis	Respiratory, thoracic and mediastinal disorders	—	—

Data from ClinicalTrials.gov NCT03575962 adverse events section.

Sponsor's own description

This is a first time in human (FTIH), 2-period study, to assess the relative bioavailability of a mesylate salt capsule of GSK3640254, compared to a bis- hydrochloride salt capsule of GSK3640254, in healthy subjects, administered following a moderate calorie and fat meal. The subjects will be randomized to 2 sequences, Regimen AB or Regimen BA. For Regimen AB: The Regimen A, which will include oral administration of GSK3640254 bis-hydrochloride Capsule 200 milligram (mg) (reference), which will be administered, in Period 1 and Regimen B will include GSK3640254 Mesylate salt capsule (test), 200 mg, which will be administered in Period 2. For the regimen BA, the regimen B, will be administered, in Period 1 and regimen A, in Period 2. Each of the regimens will be given orally as 2 capsules in the morning, as per randomization sequence. There will be a minimum washout of 7 days between each dose of study treatment. A total, of 14 subjects, are planned to be enrolled in the study. The maximum duration of the study from screening to follow-up is approximately 7 weeks.

Publications & conference data

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

Phase I evaluation of the safety, tolerability, and pharmacokinetics of GSK3640254, a next-generation HIV-1 maturation inhibitor.
Joshi SR, Fernando D, Igwe S, McKenzie L, et al · · 2020 · cited 24× · PMID 33200887 · DOI 10.1002/prp2.671
A Phase I Evaluation of the Pharmacokinetics and Tolerability of the HIV-1 Maturation Inhibitor GSK3640254 and Tenofovir Alafenamide/Emtricitabine in Healthy Participants.
Pene Dumitrescu T, Joshi SR, Xu J, Zhan J, et al · · 2021 · cited 13× · PMID 33753329 · DOI 10.1128/aac.02173-20
Relative Bioavailability and Food Effect of GSK3640254 Tablet and Capsule Formulations in Healthy Participants.
Johnson M, Pene Dumitrescu T, Joshi SR, Mathew A, et al · · 2022 · cited 4× · PMID 34995417 · DOI 10.1002/cpdd.1051

Verify or expand the search:

Other recruiting trials for HIV Infections

Currently open trials in the same condition.

NCT07225530 — Implementation of Screen, Treat, and Triage for Women Living With HIV in La Romana (iSTAR) · NA · recruiting
NCT07202546 — A Phase 2b Study Evaluating Oral VH4524184 Regimens in Treatment Naïve Persons With HIV-1 (INNOVATE Study) · Phase 2 · recruiting
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NCT07235852 — Pilot Testing Into the Feasibility of the Developed Cognitive Behavioral Therapy Intervention · NA · recruiting
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Other ViiV Healthcare trials

Trials by the same sponsor.

NCT07393659 — A Continued Access Study for Participants Transitioning From ViiV Healthcare-sponsored or ViiV Healthcare-collaborative · Phase 3 · not yet recruiting
NCT07525544 — A Study to Investigate the Safety and PK of VH4770359 in Healthy Participants · Phase 1 · not yet recruiting
NCT07275606 — A Study to Investigate Cabotegravir for Neonates Exposed to HIV-1 · Phase 1, PHASE2 · not yet recruiting
NCT07202546 — A Phase 2b Study Evaluating Oral VH4524184 Regimens in Treatment Naïve Persons With HIV-1 (INNOVATE Study) · Phase 2 · recruiting
NCT07053384 — A Study to Investigate the Use of VH3810109 With or Without Fostemsavir (FTR) to Reduce the Size and Activity of the Vir · Phase 1 · active not recruiting

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 NCT03575962 (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 ViiV Healthcare
Last refreshed: 6 September 2019

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/NCT03575962.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing