Study Of The Effects Of SB 480848 (Darapladib) On The Electrical Conduction Of The Heart

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Atherosclerosis

Treatments: Drug: Darapladib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00411073

SB 480848/035

Details and patient eligibility

About

This is a study to assess the effects of darapladib on the cardiac conduction of the heart as compared to placebo and moxifloxacin. This a four period crossover design with each period lasting about 10 days. There will be a 7 to 10 day wash out in between each period.

Enrollment: 72 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy
• Body weight greater than 50 kg (110 lbs) and a body mass index between 19 and 30
• Signed and dated written informed consent prior to admission to the study
• Subject is able to understand and comply with protocol requirements, instructions and protocol-stated restrictions

Exclusion criteria

• cardiac abnormalities
• history of asthma or severe allergic reactions
• history of alcohol or drug abuse
• use of prescription or non-prescription drugs or vitamins or herbal supplements
• history of cholecystectomy or biliary tract disease
• pregnant or nursing women
• history of allergy to the study drugs

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind