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A Study With Darapladib to Collect Tolerability Information
This study is currently recruiting participants.
Verified by GlaxoSmithKline, June 2008
First Received: June 20, 2008   No Changes Posted
Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00704431
  Purpose

Subjects will receive their first dose of darapladib in the clinical research unit (CRU), and the remaining 9 days of dosing will occur at home.

Subjects will record any adverse events throughout the dosing period in a paper diary. Subjects will return to the CRU 10-14 days after the last dose of darapladib for a follow-up visit. The total study duration for each subject including the screening, treatment and follow-up periods will be approximately 4 weeks.


Condition Intervention Phase
Atherosclerosis
Drug: SB-480848 (darapladib)
Phase I

Drug Information available for: Darapladib
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title: An Open Label, Single Session Study to Collect Tolerability Information Following Repeat Dosing of Darapladib in Healthy Adult Subjects

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Adverse events as reported by subjects.

Estimated Enrollment: 12
Study Start Date: May 2008
Estimated Study Completion Date: June 2008
Estimated Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy as determined by a responsible physician, based on a medical evaluation including medical history, physical examination, laboratory tests and ECG.
  • Male or female between 18 and 65 years of age inclusive, at the time of signing the informed consent.
  • A female subject is eligible to participate if she is of:

    • Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea
    • Child-bearing potential and agrees to use one of the contraception methods listed in the protocol for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until the follow-up visit.
  • Body weight >= 50 kg and BMI within the range 19 - 30 kg/m2 (inclusive).
  • Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
  • QTcB or QTcF < 450 msec; or QTc < 480 msec in subjects with Bundle Branch Block.

Exclusion Criteria:

  • A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
  • The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
  • Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
  • History of drug abuse.
  • History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
  • History of anaphylaxis, anaphylactoid reactions and severe allergic responses.
  • History of adult asthma manifested by bronchospasms in the past 6 months or currently taking regular anti-asthmatic medication.
  • Currently receiving oral or injectable strong CYP3A4 inhibitor(s).
  • Consumption of grapefruit or grapefruit juice within 7 days prior to first dose of study medication.
  • Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
  • Pregnant females as determined by positive serum hCG test at screening.
  • Lactating females.
  • Unwillingness or inability to follow the procedures outlined in the protocol.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00704431

Locations
United States, Pennsylvania
GSK Clinical Trials Call Center Recruiting
King of Prussia, Pennsylvania, United States, 19406
Contact: Yvonne Surh     877-379-3718        
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, M.D. GlaxoSmithKline
  More Information

No publications provided

Study ID Numbers: LPL111814
Study First Received: June 20, 2008
Last Updated: June 20, 2008
ClinicalTrials.gov Identifier: NCT00704431     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
SB-480848,
darapladib,
tolerability

Study placed in the following topic categories:
Arterial Occlusive Diseases
Atherosclerosis
Vascular Diseases
Healthy
Arteriosclerosis

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Atherosclerosis
Vascular Diseases
Cardiovascular Diseases
Arteriosclerosis

ClinicalTrials.gov processed this record on May 06, 2009