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NCT03234036 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study of HIV Infections and Infection, Human Immunodeficiency Virus, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
- 1
- Study location
NCT03234036 is a Phase 1 study of HIV Infections and Infection, Human Immunodeficiency Virus that has completed, run by GlaxoSmithKline. The registered enrollment target is 26 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03234036, a Phase 1 study of HIV Infections and Infection, Human Immunodeficiency Virus, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 26 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Conditions Studied
Interventions
- DRUG GSK2838232 100 mg tablet
- DRUG GSK2838232 50 mg capsule
- DRUG Ritonavir 100 mg tablets
- DRUG Placebo for GSK2838232 tablets
Study Locations (1)
Maryland
- GSK Investigational Site - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2017-08-02 |
| Est. Completion | 2017-11-10 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03234036
The ClinicalTrials.gov registry entry for NCT03234036 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (94% lower). The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with HIV Infections appearing as the primary indexed condition, and to 4 interventions - of which GSK2838232 100 mg tablet is the first listed.
NCT03234036 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT03234036 about?
NCT03234036 is a clinical study titled "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". 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) ...
What is the current status of trial NCT03234036?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2017-08-02. Estimated completion is 2017-11-10.
What conditions does trial NCT03234036 study?
This clinical trial studies the following conditions: HIV Infections, Infection, Human Immunodeficiency Virus.
What interventions are being tested in trial NCT03234036?
The interventions under investigation include: GSK2838232 100 mg tablet (DRUG), GSK2838232 50 mg capsule (DRUG), Ritonavir 100 mg tablets (DRUG), Placebo for GSK2838232 tablets (DRUG).
Who is sponsoring clinical trial NCT03234036?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03234036 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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