Relative Bioavailability Study on a Single Dose of GW842166X in Healthy Male and Female Subjects.

NCT ID: NCT00536497

Last Updated: 2015-02-16

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30

Brief Summary

GW842166X is a selective non-cannabinoid CB2 receptor agonist, which is undergoing clinical development as a novel oral treatment for inflammatory pain. The purpose of the study is to compare the effects of formulation, food and particle size on the pharmacokinetic profiles of a single 175mg dose of GW842166X in healthy male and female volunteers.

Conditions

Healthy Subjects

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

GW842166X

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Body weight >50 Kg and BMI within the range 18.5-29.9 Kg/m2 inclusive.
• Healthy as judged by a responsible physician.

Exclusion Criteria

• Positive pre-study urine screen for drugs of abuse or alcohol breath test.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Other Identifiers

CBA109358

Identifier Type: -

Identifier Source: org_study_id