Who is sponsoring NCT03234036?

NCT03234036 is sponsored by GlaxoSmithKline.

What drugs are being tested in NCT03234036?

Interventions in NCT03234036: GSK2838232 100 mg tablet, GSK2838232 50 mg capsule, Ritonavir 100 mg tablets, Placebo for GSK2838232 tablets.

What condition does NCT03234036 study?

NCT03234036 studies Infection, Human Immunodeficiency Virus, HIV Infections.

Is NCT03234036 still recruiting?

NCT03234036 is currently completed. Last updated 28 October 2020.

Are results published for NCT03234036?

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

Last reviewed 2020-10-28 · How we verify

NCT03234036

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

A Two-part Study to Compare a Tablet and Capsule Formulation of GSK2838232 With and Without Food, and to Assess the Safety and Drug Levels of Repeated Once-daily Doses of GSK2838232 Without Ritonavir

Completed Phase 1 Results posted Last updated 28 October 2020

What this trial tests

Phase 1 trial testing GSK2838232 100 mg tablet in Infection, Human Immunodeficiency Virus in 26 participants. Completed in 10 November 2017.

Timeline

2 August 2017

Primary endpoint
10 November 2017

10 November 2017

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	treatment
Enrollment	26
Start date	2 August 2017
Primary completion	10 November 2017
Estimated completion	10 November 2017
Sites	1 location across United States

Drugs / interventions tested

GSK2838232 100 mg tablet — full drug profile →
GSK2838232 50 mg capsule — full drug profile →
Ritonavir 100 mg tablets — full drug profile →
Placebo for GSK2838232 tablets — full drug profile →

Conditions studied

Infection, Human Immunodeficiency Virus — all drugs for Infection, Human Immunodeficiency Virus →
HIV Infections — all drugs for HIV Infections →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 18 to 55, any sex, with Infection, Human Immunodeficiency Virus or 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.

Part 1: Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC [0-infinity]) Following Administration of GSK2838232 Tablet and Capsule Formulation in Fed State Primary · Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post-dose in treatment periods 1 and 2 of Part 1

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232 given as tablet and capsule formulation in fed state. Pharmacokinetic parameters were determined using standard non-compartmental methods. Pharmacokinetic Population comprised of all participants in the Safety Population who had at least 1 non-missing pharmacokinetic assessment (Non-quantifiable \[NQ\] values were considered as non-missing values).

Group	Value	95% CI
Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed	4672.28	± 40.68
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed	4437.98	± 30.83

Part 1: Maximum Observed Concentration (Cmax) Following Administration of GSK2838232 Tablet and Capsule Formulation in Fed State Primary · Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post-dose in treatment periods 1 and 2 of Part 1

Group	Value	95% CI
Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed	109.054	± 48.01
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed	118.118	± 27.59

Part 1: AUC (0-infinity) Following Administration of GSK2838232 Tablet in Fasted and Fed State Primary · Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post-dose in treatment periods 1, 2 and 3 of Part 1

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232 given as tablet formulation in fed and fasted state. Pharmacokinetic parameters were determined using standard non-compartmental methods.

Group	Value	95% CI
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed	4437.98	± 30.83
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted	1816.27	± 36.42

Part 1: Cmax Following Administration of GSK2838232 Tablet in Fasted and Fed State Primary · Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post-dose in treatment periods 1, 2 and 3 of Part 1

Group	Value	95% CI
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed	118.118	± 27.59
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted	50.437	± 35.61

Part 1: Time of Occurrence of Cmax (Tmax) Following Administration of GSK2838232 Tablet in Fasted and Fed State Primary · Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post-dose in treatment periods 1, 2 and 3 of Part 1

Group	Value	95% CI
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed	5.983	2.00 – 24.03
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted	3.508	2.00 – 11.97

Part 2: Number of Participants With Serious Adverse Events (SAEs) and Non-SAEs Primary · 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 study treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/ birth defect, is associated with liver injury or impaired liver function or any other situations as per medical or scientific judgment. Safety Popul

Any SAE

Group	Value	95% CI
Part 2: Placebo	0
Part 2: GSK2838232 500 mg Tablet Fed	0

Any non-SAE

Group	Value	95% CI
Part 2: Placebo	1
Part 2: GSK2838232 500 mg Tablet Fed	0

Part 2: Number of Participants With Worst Case Hematology Results to Potential Clinical Importance (PCI) Criteria Primary · Up to 25 days

Blood samples were collected from participants for analysis of following hematology parameters; hematocrit, hemoglobin, leukocytes, lymphocytes, neutrophils and platelets. PCI ranges were \< 0.075 or \>0.54 proportion of red blood cells in blood for hematocrit, \<25 or \>180 grams per liter (g/L) for hemoglobin, \< 3 or \>20 cells per liter (cells/L) for leukocytes, 0.8 x10\^9 cells/L for lymphocytes, 1.5 x10\^9 cells/L for neutrophils, and \<100 or \>550 cells/L for platelets. Participants were counted in the worst case category that their value changes to (low, within range or no change, or

Hematocrit; To Low

Group	Value	95% CI
Part 2: Placebo	0
Part 2: GSK2838232 500 mg Tablet Fed	0

Hematocrit; To within Range or No Change

Group	Value	95% CI
Part 2: Placebo	3
Part 2: GSK2838232 500 mg Tablet Fed	7

Hematocrit; To High

Group	Value	95% CI
Part 2: Placebo	0
Part 2: GSK2838232 500 mg Tablet Fed	0

Hemoglobin; To Low

Group	Value	95% CI
Part 2: Placebo	0
Part 2: GSK2838232 500 mg Tablet Fed	0

Hemoglobin; To within Range or No Change

Group	Value	95% CI
Part 2: Placebo	3
Part 2: GSK2838232 500 mg Tablet Fed	7

Hemoglobin; To High

Group	Value	95% CI
Part 2: Placebo	0
Part 2: GSK2838232 500 mg Tablet Fed	0

Leukocytes; To Low

Group	Value	95% CI
Part 2: Placebo	0
Part 2: GSK2838232 500 mg Tablet Fed	0

Leukocytes; To within Range or No Change

Group	Value	95% CI
Part 2: Placebo	3
Part 2: GSK2838232 500 mg Tablet Fed	7

Part 2: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria Primary · Up to 25 days

Blood samples were collected from participants for analysis of following clinical chemistry parameters; glucose, alanine aminotransferase (ALT), albumin, alkaline phosphatase, aspartate aminotransferase (AST), bilirubin, calcium, potassium and sodium. PCI ranges were \<30 g/L for albumin, \<2 or \>2.75 millimoles per liter (mmol/L) for calcium, \<3 or \>9 mmol/L for glucose, \>=2 times Upper limit of Normal (ULN) units per liter (U/L) for ALT, \>=2 times ULN U/L for alkaline phosphatase, \>=2 times ULN U/L for AST, \>=1.5 times ULN micromoles per liter (µmol/L) for bilirubin, \<3 or \>5.5 mmol

Glucose; To Low

Group	Value	95% CI
Part 2: Placebo	0
Part 2: GSK2838232 500 mg Tablet Fed	0

Glucose; To within Range or No Change

Group	Value	95% CI
Part 2: Placebo	3
Part 2: GSK2838232 500 mg Tablet Fed	7

Glucose; To High

Group	Value	95% CI
Part 2: Placebo	0
Part 2: GSK2838232 500 mg Tablet Fed	0

ALT; To Low

Group	Value	95% CI
Part 2: Placebo	0
Part 2: GSK2838232 500 mg Tablet Fed	0

ALT; To within Range or No Change

Group	Value	95% CI
Part 2: Placebo	3
Part 2: GSK2838232 500 mg Tablet Fed	7

ALT; To High

Group	Value	95% CI
Part 2: Placebo	0
Part 2: GSK2838232 500 mg Tablet Fed	0

Albumin; To Low

Group	Value	95% CI
Part 2: Placebo	0
Part 2: GSK2838232 500 mg Tablet Fed	0

Albumin; To within Range or No Change

Group	Value	95% CI
Part 2: Placebo	3
Part 2: GSK2838232 500 mg Tablet Fed	7

Part 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria Primary · Up to 25 days

Urine samples were collected from participants for analysis of following urinalysis parameters; specific gravity, potential of hydrogen (pH), presence of glucose, protein, occult blood, ketones in urine analyzed by dipstick method. The dipstick test gives results in a semi-quantitative manner. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The reference range is 1.002-1.030. Urine pH is an acid-base measurement. Normal urine has a slightly acid pH (5.0 - 6.0). Participants were counted in t

Glucose; To Low

Group	Value	95% CI
Part 2: Placebo	0
Part 2: GSK2838232 500 mg Tablet Fed	0

Glucose; To Normal or No Change

Group	Value	95% CI
Part 2: Placebo	3
Part 2: GSK2838232 500 mg Tablet Fed	7

Glucose; To High

Group	Value	95% CI
Part 2: Placebo	0
Part 2: GSK2838232 500 mg Tablet Fed	0

Glucose; To Abnormal

Group	Value	95% CI
Part 2: Placebo	0
Part 2: GSK2838232 500 mg Tablet Fed	0

Ketones; To Low

Group	Value	95% CI
Part 2: Placebo	0
Part 2: GSK2838232 500 mg Tablet Fed	0

Ketones; To Normal or No Change

Group	Value	95% CI
Part 2: Placebo	3
Part 2: GSK2838232 500 mg Tablet Fed	7

Ketones; To High

Group	Value	95% CI
Part 2: Placebo	0
Part 2: GSK2838232 500 mg Tablet Fed	0

Ketones; To Abnormal

Group	Value	95% CI
Part 2: Placebo	0
Part 2: GSK2838232 500 mg Tablet Fed	0

Part 2: Blood Pressure at Indicated Time Points Primary · Day -1; Pre-dose, 1, 4 hours on Day 1; 24 hours (Day 2); 48 hours (Day 3); 72 hours (Day 4), Days 5, 6, 7, 8, 9, 10; Pre-dose, 1, 4 , 24, 48, 72 hours on Day 11; Follow-up (Day 25)

Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured in supine position after 10 minutes rest for the participants at indicated time points.

DBP; DAY -1

Group	Value	95% CI
Part 2: Placebo	73.667	± 7.5056
Part 2: GSK2838232 500 mg Tablet Fed	73.143	± 4.7759

DBP; DAY 1, PREDOSE

Group	Value	95% CI
Part 2: Placebo	65.443	± 2.6925
Part 2: GSK2838232 500 mg Tablet Fed	72.333	± 8.1636

DBP; DAY 1, 1 Hour

Group	Value	95% CI
Part 2: Placebo	54.667	± 3.7859
Part 2: GSK2838232 500 mg Tablet Fed	64.714	± 5.8228

DBP; DAY 1, 4 Hours

Group	Value	95% CI
Part 2: Placebo	62.000	± 1.0000
Part 2: GSK2838232 500 mg Tablet Fed	63.714	± 6.7507

DBP; DAY 2, 24 Hours

Group	Value	95% CI
Part 2: Placebo	73.667	± 4.0415
Part 2: GSK2838232 500 mg Tablet Fed	73.714	± 6.0474

DBP; DAY 3, 48 Hours

Group	Value	95% CI
Part 2: Placebo	66.000	± 1.7321
Part 2: GSK2838232 500 mg Tablet Fed	68.000	± 7.3485

DBP; DAY 4, 72 Hours

Group	Value	95% CI
Part 2: Placebo	69.000	± 2.6458
Part 2: GSK2838232 500 mg Tablet Fed	65.143	± 8.3552

DBP; DAY 5

Group	Value	95% CI
Part 2: Placebo	62.333	± 4.9329
Part 2: GSK2838232 500 mg Tablet Fed	65.000	± 7.3258

Part 2: Change From Baseline in Blood Pressure Primary · Baseline (Day -1) and 1, 4 hours on Day 1; 24 hours (Day 2); 48 hours (Day 3); 72 hours (Day 4), Days 5, 6, 7, 8, 9, 10; Pre-dose, 1, 4 , 24, 48, 72 hours on Day 11; Follow-up (Day 25)

SBP and DBP were measured in supine position after 10 minutes rest for participants at indicated time points. Baseline was defined as the latest pre-dose assessment, including those from unscheduled visits. Change from Baseline was defined as any visit value minus Baseline value.

DBP; DAY 1, 1 Hour

Group	Value	95% CI
Part 2: Placebo	-10.777	± 4.6690
Part 2: GSK2838232 500 mg Tablet Fed	-7.619	± 4.9086

DBP; DAY 1, 4 Hours

Group	Value	95% CI
Part 2: Placebo	-3.443	± 3.6851
Part 2: GSK2838232 500 mg Tablet Fed	-8.619	± 9.3099

DBP; DAY 2, 24 Hours

Group	Value	95% CI
Part 2: Placebo	8.223	± 2.5455
Part 2: GSK2838232 500 mg Tablet Fed	1.381	± 5.6866

DBP; DAY 3, 48 Hours

Group	Value	95% CI
Part 2: Placebo	0.557	± 4.3485
Part 2: GSK2838232 500 mg Tablet Fed	-4.333	± 8.5244

DBP; DAY 4, 72 Hours

Group	Value	95% CI
Part 2: Placebo	3.557	± 2.2180
Part 2: GSK2838232 500 mg Tablet Fed	-7.190	± 8.9524

DBP; DAY 5

Group	Value	95% CI
Part 2: Placebo	-3.110	± 2.8366
Part 2: GSK2838232 500 mg Tablet Fed	-7.333	± 10.9039

DBP; DAY 6

Group	Value	95% CI
Part 2: Placebo	-2.777	± 3.7175
Part 2: GSK2838232 500 mg Tablet Fed	-6.190	± 7.8255

DBP; DAY 7

Group	Value	95% CI
Part 2: Placebo	-1.110	± 4.4381
Part 2: GSK2838232 500 mg Tablet Fed	-5.047	± 8.9388

Part 2: Pulse Rate at Indicated Time Points Primary · Day -1; Pre-dose, 1, 4 hours on Day 1; 24 hours (Day 2); 48 hours (Day 3); 72 hours (Day 4), Days 5, 6, 7, 8, 9, 10; Pre-dose, 1, 4 , 24, 48, 72 hours on Day 11; Follow-up (Day 25)

Pulse rate of participants was measured in supine position after 10 minutes rest at indicated time points.

DAY -1

Group	Value	95% CI
Part 2: Placebo	63.667	± 12.4231
Part 2: GSK2838232 500 mg Tablet Fed	64.143	± 11.7817

DAY 1, PREDOSE

Group	Value	95% CI
Part 2: Placebo	63.663	± 4.0415
Part 2: GSK2838232 500 mg Tablet Fed	63.714	± 11.3991

DAY 1, 1 Hour

Group	Value	95% CI
Part 2: Placebo	68.000	± 8.5440
Part 2: GSK2838232 500 mg Tablet Fed	72.286	± 7.5214

DAY 1, 4 Hours

Group	Value	95% CI
Part 2: Placebo	64.667	± 3.0551
Part 2: GSK2838232 500 mg Tablet Fed	66.000	± 10.1160

DAY 2, 24 Hours

Group	Value	95% CI
Part 2: Placebo	57.667	± 2.8868
Part 2: GSK2838232 500 mg Tablet Fed	58.286	± 8.7123

DAY 3, 48 Hours

Group	Value	95% CI
Part 2: Placebo	58.000	± 2.6458
Part 2: GSK2838232 500 mg Tablet Fed	59.429	± 7.9762

DAY 4, 72 Hours

Group	Value	95% CI
Part 2: Placebo	58.667	± 1.1547
Part 2: GSK2838232 500 mg Tablet Fed	58.286	± 7.7613

DAY 5

Group	Value	95% CI
Part 2: Placebo	60.667	± 2.5166
Part 2: GSK2838232 500 mg Tablet Fed	66.429	± 10.3900

Adverse events — posted to ClinicalTrials.gov

Time frame: Serious adverse events (SAEs) and Non-SAEs were collected up to 60 days in Part 1 of the study and up to 25 days in Part 2 of the study.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed

Serious: 0/15 (0%)

Deaths: 0/15

Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed

Serious: 0/15 (0%)

Deaths: 0/15

Part 1: GSK 200 mg/Ritonavir Tablet Fasted

Serious: 0/14 (0%)

Deaths: 0/14

Part 2: Placebo

Serious: 0/3 (0%)

Deaths: 0/3

Part 2: GSK2838232 500 mg Tablet Fed

Serious: 0/7 (0%)

Deaths: 0/7

Other adverse events (15 terms — click to expand)

Reaction	System	Part 1: GSK2838232 200 mg/…	Part 1: GSK2838232 200 mg/…	Part 1: GSK 200 mg/Ritonav…	Part 2: Placebo	Part 2: GSK2838232 500 mg …
Headache	Nervous system disorders	—	—	—	—	—
Abdominal discomfort	Gastrointestinal disorders	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—
Abdominal pain lower	Gastrointestinal disorders	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—
Flatulence	Gastrointestinal disorders	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—
Chest discomfort	General disorders	—	—	—	—	—
Chills	General disorders	—	—	—	—	—
Infusion site pain	General disorders	—	—	—	—	—
Skin abrasion	Injury, poisoning and procedural complications	—	—	—	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Syncope	Nervous system disorders	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—

Data from ClinicalTrials.gov NCT03234036 adverse events section.

Sponsor's own description

This study will be conducted in two Parts to confirm the acceptability/selection of a tablet formulation for future clinical development of GSK2838232. Part 1 of the study will assess single ritonavir (RTV)-boosted doses of a new tablet formulation given with food (containing approximately 30% fat) against the reference capsule formulation also given with food and then will assess the impact of fasted conditions on the tablet performance. In Part 2, non-boosted GSK2838232 will be given as once-daily tablet doses for 11 days in a separate group of subjects, assuming the tablet performance is considered acceptable from Part 1. Approximately 16 healthy subjects will be enrolled to provide at least 12 evaluable subjects through the three study periods in Part 1. 10 healthy subjects will be enrolled to provide at least 8 evaluable subjects through the single study period in Part 2. The maximum duration of study participation will be approximately 9 to 10 weeks for Part 1; and 8 to 9 weeks for Part 2.

Publications & conference data

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

Verify or expand the search:

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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 NCT03234036 (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 GlaxoSmithKline
Last refreshed: 28 October 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/NCT03234036.

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