An Open-label Single Dose Randomized, Parallel Group Study Followed by Single-blind Repeat Dosing, to Compare the Relative Bioavailability of GSK2212836.
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|ClinicalTrials.gov Identifier: NCT00996268|
Recruitment Status : Completed
First Posted : October 16, 2009
Last Update Posted : June 22, 2017
Sixteen healthy subjects will be randomized to each of the 3 parallel treatment groups. Eligible subjects will check in to the clinical unit on Day -2 and have 24-hr pharmacokinetic collections on Day -1 and on Day 1. Once the pharmacokinetic parameters of the formulations have been analyzed, doses of GSK2212836 will be selected for further study in Part B. Subjects from Part A will participate in Part B.
Part B is a single blind, randomized, placebo controlled study that will consist of a 2-week repeat dose period with 3 dose levels and one dose of the marketed formulation of GSK2212836. Subjects will check in to the clinical unit on Day -3; will participate in a test meal on Day -2 and have 24-hr baseline pharmacokinetic profiles on Day -1 and Day 1. Subjects will be released from the clinic on Day 2, and return for daily dosing on Days 3 through 12. On Day 6, they will also have a brief outpatient visit. Subjects will check into the clinic again on the evening of Day 12, and on Day 13 they will again have 24-hr pharmacokinetic profiles collected. Subjects will be released from the clinical research unit on Day 14, following a test meal, triglyceride sampling and check-out assessments, and will be released from the study 5-10 days later after completing a follow up visit.
|Condition or disease||Intervention/treatment||Phase|
|Cardiovascular Disease||Drug: GSK2212836||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||46 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||An Open-label Single Dose Randomized, Parallel Group Study Followed by Single-blind Repeat Dosing, to Compare the Relative Bioavailability of GSK2212836|
|Actual Study Start Date :||October 15, 2009|
|Actual Primary Completion Date :||January 4, 2010|
|Actual Study Completion Date :||January 4, 2010|
Experimental: Part A
Three groups of sixteen healthy subjects will be randomized to single doses of 3 different formulations of GSK2212836.
Treatment A - GSK2212836 test formulation 1, Treatment B - GSK2212836 test formulation 2, or Treatment C -GSK2212836 marketed formulation.
Experimental: Part B
Four cohorts of at least 10 subjects will participate in a 2-week repeat dose period with 4 dose levels (based on data obtained in Part A) of the GSK2212836 test formulations or placebo.
Treatment D - low dose of GSK2212836 test formulation, Treatment E - medium dose of GSK2212836 test formulation, Treatment F - high dose of GSK2212836 test formulation, Treatment G - GSK2212836 marketed formulation, or Placebo.
- Part A: To determine the total (AUC(0 to infinity)) and peak (Cmax) exposure of GSK2212836 [ Time Frame: 24 hours ]
- Part B: PK parameters AUC(0-24h) and Cmax following 14 days of dosing with GSK2212836 [ Time Frame: 14 days ]
- Part A: To assess the relative bioavailability of GSK2212836 test capsules vs the reference formulation GSK2213836 [ Time Frame: 24 hours ]
- Part B: To estimate the accumulation and dose proportionality of GSK2212836 after repeat dosing of the test formulation [ Time Frame: 14 days ]
- Part A: Safety and tolerability parameters following single doses of GSK2212836 test formulation including adverse events, clinical laboratory, ECGs and vital signs assessments. [ Time Frame: 24 hours ]
- Part A: Secondary PK parameters including: tmax, t1/2 and baseline-corrected AUC(0-24h) [ Time Frame: 24 hours ]
- Part B: Safety and tolerability parameters following repeat doses of GSK2212836 test formulation including adverse events, clinical laboratory, ECGs and vital signs assessments [ Time Frame: 14 days ]
- Part B: Secondary PK parameters including: tmax, t1/2 [ Time Frame: 14 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00996268
|United States, New York|
|GSK Investigational Site|
|Buffalo, New York, United States, 14202|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|