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NCT01495065 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate Single and Repeat Doses of IV GSK2251052 in Healthy Male Japanese and Caucasian Subjects and Repeat Doses of Supratherapeutic Doses of IV GSK2251052 in Healthy Volunteers
A Phase 1 study, sponsored by GlaxoSmithKline.
- Terminated
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
NCT01495065: Clinical Trial Phase 1 study, sponsored by GlaxoSmithKline.
NCT01495065 is a Phase 1 study that was terminated before completion, run by GlaxoSmithKline. The registered enrollment target is 8 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01495065, a Phase 1 study, was terminated before completion, sponsored by GlaxoSmithKline.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
Study Summary
This is a two-part study. Part A is a three-period study in approximately 24 healthy male Japanese and Caucasian subjects. Period 1 and Period 2 will be an open label study to investigate the safety, tolerability, and pharmacokinetics of single ascending intravenous doses of GSK2251052. Period 3 is a single blind, placebo controlled, repeat fixed dose design to evaluate the safety, tolerability and pharmacokinetics of multiple intravenous doses of GSK2251052 for 12 days. The selection of the repeat IV dose will be based on the results from Periods 1 and 2. Japanese subjects will be stratified based on their metabolic genotype, polymorphic or wild-type for ADH and ALDH. Caucasian subjects are not anticipated to have these enzyme polymorphisms and therefore will not be stratified. Part B is a two cohort, single-blind, randomized, placebo-controlled, dose-rising, repeat dose study in approximately 24 healthy male and female subjects to evaluate the safety, tolerability, and pharmacokinetics of supratherapeutic IV doses of GSK2251052 for 10 days. Cohort 1 subjects will be randomized to receive 2250 mg of GSK2251052 or placebo and Cohort 2 subjects will be randomized to receive 3000 mg GSK2251052 or placebo. The decision to conduct Cohort 2 of Part B will be based on the available toxicology cover results from ongoing preclinical toxicity studies.
Primary Outcome
pharmacokinetic endpoints maximum observed concentration fixed nominal time (Cmax), area under the concentration-time curve from time zero extrapolated to infinite time (AUC(0-∞), area under the concentration-time curve from time zero to last time of quantifiable concentration within a subject across all treatments (AUC(0-t), AUC(0-12), time of occurrence of Cmax (tmax), time of last quantifiable concentration (tlast), terminal phase half-life (t1/2), volume of distribution at steady state (Vss)
Interventions
- DRUG GSK2251052 750 mg
- DRUG GSK2251052 1500 mg
- DRUG GSK2251052 1500 mg BID
- DRUG GSK2251052 2250 mg
- DRUG GSK2251052 3000 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2011-12-19 |
| Est. Completion | 2012-02-17 |
| Phase | Phase 1 |
Why NCT01495065 stopped before completion
NCT01495065 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 5 interventions - of which GSK2251052 750 mg is the first listed.
NCT01495065 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01495065 about?
NCT01495065 is a clinical study titled "A Study to Evaluate Single and Repeat Doses of IV GSK2251052 in Healthy Male Japanese and Caucasian Subjects and Repeat Doses of Supratherapeutic Doses of IV GSK2251052 in Healthy Volunteers". This is a two-part study. Part A is a three-period study in approximately 24 healthy male Japanese and Caucasian subjects. Period 1 and Period 2 will be an open label study to investigate the safety, tolerability, and pharmacokinetics of single ascending intravenous doses of GSK2251052. Period 3 is ...
What is the current status of trial NCT01495065?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2011-12-19. Estimated completion is 2012-02-17.
What interventions are being tested in trial NCT01495065?
The interventions under investigation include: GSK2251052 750 mg (DRUG), GSK2251052 1500 mg (DRUG), GSK2251052 1500 mg BID (DRUG), GSK2251052 2250 mg (DRUG), GSK2251052 3000 mg (DRUG).
Who is sponsoring clinical trial NCT01495065?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01495065's enrollment target sits among peer trials
8 1959th of 2000 higher than 29 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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