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NCT02795754 · ClinicalTrials.gov registry record · Phase 1

Single and Repeated Dose Escalation Study of GSK2838232

A Phase 1 study of Infection, Human Immunodeficiency Virus, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 1
Development phase
62
Enrollment target
1
Study location

NCT02795754 is a Phase 1 study of Infection, Human Immunodeficiency Virus that has completed, run by GlaxoSmithKline. The registered enrollment target is 62 participants, below the 144-participant average among 19 other Infection, Human Immunodeficiency Virus trials with a reported enrollment target (57% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT02795754, a Phase 1 study of Infection, Human Immunodeficiency Virus, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 1
Development phase
62 participants
Enrollment target
1
Study location

Study Summary

GSK2838232 is a Human Immunodeficiency Virus (HIV) maturation inhibitor being developed for the treatment of HIV in combination with other antiretroviral therapy (ART). The primary objectives of this study are to investigate the safety, tolerability, and pharmacokinetics (PK) of single and repeat doses of GSK2838232. This study will be a double-blind, placebo-controlled, single and repeat dose escalation study. This study will be conducted in two Parts: single escalating doses (Part 1A and 1B), and repeated escalating once daily (QD) doses for 11 days (Part 2) of GSK2838232 co-dosed with RTV. During Part 1A, single doses of GSK2838232 (as of active pharmaceutical ingredient-powder in bottle \[API PiB\]) 50 milligrams (mg), 100mg and 200mg will be administered with RTV. Part 1B will evaluate the relative bioavailability of single doses of crystalline active pharmaceutical ingredient (API) Immediate Release Tablet (IR) tablets versus API PiB as reference, administered with RTV. In Part 2, multiple doses of GSK2838232 will be co-administered with RTV 100mg QD for 11 days as sequential dose cohorts. Maximum duration of study participation will be approximately 10 weeks.

Conditions Studied

Infection, Human Immunodeficiency Virus

Interventions

  • DRUG Ritonavir
  • DRUG GSK2838232 PIB
  • DRUG GSK2838232 IR1
  • DRUG GSK2838232 IR2
  • DRUG Placebo PIB

Study Locations (1)

Maryland

  • GSK Investigational Site - Baltimore

Trial Details

FieldValue
Enrollment Target 62 participants
Start Date 2016-03
Est. Completion 2016-12
Phase Phase 1

Sponsor

GlaxoSmithKline

1,345 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02795754

The ClinicalTrials.gov registry entry for NCT02795754 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 62 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 144-participant average among 19 other Infection, Human Immunodeficiency Virus trials with a reported enrollment target (57% lower). The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Infection, Human Immunodeficiency Virus appearing as the primary indexed condition, and to 5 interventions - of which Ritonavir is the first listed.

NCT02795754 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.

Frequently Asked Questions

What is clinical trial NCT02795754 about?

NCT02795754 is a clinical study titled "Single and Repeated Dose Escalation Study of GSK2838232". GSK2838232 is a Human Immunodeficiency Virus (HIV) maturation inhibitor being developed for the treatment of HIV in combination with other antiretroviral therapy (ART). The primary objectives of this study are to investigate the safety, tolerability, and pharmacokinetics (PK) of single and repeat do...

What is the current status of trial NCT02795754?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 62 participants. The study started on 2016-03. Estimated completion is 2016-12.

What conditions does trial NCT02795754 study?

This clinical trial studies the following conditions: Infection, Human Immunodeficiency Virus.

What interventions are being tested in trial NCT02795754?

The interventions under investigation include: Ritonavir (DRUG), GSK2838232 PIB (DRUG), GSK2838232 IR1 (DRUG), GSK2838232 IR2 (DRUG), Placebo PIB (DRUG).

Who is sponsoring clinical trial NCT02795754?

This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02795754 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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.