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NCT00411073 Clinical Trial

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

Atherosclerosis Clinical Trial

Official title:
A Study to Evaluate the Effect of Repeat Oral Doses of Darapladib on Cardiac Conduction as Compared to Placebo and a Single Oral Dose of Moxifloxacin

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00411073
Other study ID # SB 480848/035
Secondary ID
Status Completed
Phase Phase 1
First received December 12, 2006
Last updated October 27, 2016
Start date December 2006

Study information
Verified date October 2016
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 72
Est. completion date
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Darapladib

Locations
Country Name City State
United States GSK Investigational Site Evansville Indiana

Sponsors (1)
Lead Sponsor Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in QTc interval as compared to placebo and moxifloxacin throughout the study
Secondary Change in ECG parameters as compared to placebo and moxifloxacin throughout the study
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