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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 is a Phase 1 study that was terminated before completion, run by GlaxoSmithKline. The registered enrollment target is 8 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01495065
The ClinicalTrials.gov registry entry for NCT01495065 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which GSK2251052 750 mg is the first listed.
NCT01495065 reports 0 study locations.
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.
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