A Study To See If GSK256073A Can Block Niacin-Induced Flushing In Healthy Volunteers

Sponsor

GlaxoSmithKline (Industry)

Overall Status

Completed

CT.gov ID

NCT00608699

Collaborator

(none)

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To test the ability of GSK256073 to block niacin-induced flushing when GSK256073 and niacin are co-administered as single doses to HVTs.

Condition or Disease	Intervention/Treatment	Phase
Healthy Subjects Dyslipidaemias	Drug: GSK256073A tablets + IR niacin tablets	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Single (Participant)

Primary Purpose:

Diagnostic

Official Title:

A Study to Evaluate the Ability of the HM74A Agonist GSK256073A to Block Niacin-induced Flushing in Healthy Adult Subjects

Study Start Date :

Dec 1, 2007

Actual Primary Completion Date :

Apr 1, 2008

Actual Study Completion Date :

Apr 1, 2008

Outcome Measures

Primary Outcome Measures

Intensity of reported flushing - visual analogue scale; self reported assessment of flushing [up to 8 hours post dose]
Safety and tolerability of GSK256073A and immediate release niacin [up to 36 hours post dose]

Secondary Outcome Measures

Standard and Secondary pharmacokinetic endpoints of interest [up to 36 hours post dose]
Pharmacodynamic response [up to 36 hours post dose]
Pharmacodynamic response [up to 24 hours post dose]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Adult males between 18 and 55 years of age, inclusive.
Healthy subjects
Body weight > 50 kg (110 pounds) and body mass index (BMI) between 19 and 31 where:
Subjects with QTc < 450 msec at screening