Study Of Pharmacokinetics and Pharmacodynamics Effects Of GSK256073A On Healthy Volunteers

Phase 1

Completed

• Conditions: Dyslipidaemias; Healthy Subjects

• Registration Number: NCT00488449
• Lead Sponsor: GlaxoSmithKline

Brief Summary

The purpose of this study is to compare the effects of single and repeat doses of GSK256073 with placebo in HVT subjects.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2007-06-18
• Study First Submitted QC: 2007-06-19
• Study First Posted: 2007-06-20
• Primary Completion: 2007-11
• Study Completion: 2007-11
• Status Verified: 2011-02
• Last Update Submitted: 2012-05-31
• Last Update Posted: 2012-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
AEs, 12-Lead ECG, vital signs, nursing/physician observation, safety lab tests, flushing	throughout the study (Parts A &B)
Measures of accumulation ratios	throughout the study (Ro, Rp, and Rs)[Part B]
AUC and Cmax	throughout the study (Part A & B)

Secondary Outcome Measures

Name	Time	Method
LDL, HDL, ApoA1, ApoA2, Apo B and Lp(a)	on Days 1, 14, and 15.
Tmax, t½, Ae, and CLr (Parts A & B) Cmax, ss, Ct, t½, Ae, CLr, and accumulation ratios (Part B)	throughout the study
PD response: NEFA and TG (6 and 24 hours post- dose)	(6 and 24 hours post- dose)
Levels of GSK256073 to derive pharmacokinetic parameters following repeat dose administration.
Lipid levels	on Days 1, 14, and 15

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇸 Baltimore, Maryland, United States