An Open-label Single Dose Randomized, Parallel Group Study Followed by Single-blind Repeat Dosing, to Compare the Relative Bioavailability of GSK2212836.
|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 ]
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|