Last updated: 11/04/2018 08:57:36

A Study with Darapladib to Collect Tolerability Information

GSK study ID
LPL111814
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: An Open Label, Single Session Study to Collect Tolerability Information Following Repeat Dosing of Darapladib in Healthy Adult Subjects
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

Adverse events as reported by subjects.

Timeframe: From dosing through to follow-up visit.

Secondary outcomes:
Not applicable
Interventions:
Drug: SB-480848 (darapladib)
Enrollment:
2
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Atherosclerosis
Product
darapladib
Collaborators
Not applicable
Study date(s)
May 2008 to October 2008
Type
Interventional
Phase
1

Participation criteria

Sex
Female & Male
Age
18 - 65 years
Accepts healthy volunteers
Yes
  • 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 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).

Trial location(s)

Location
Status
Contact us
Contact us
Location
GSK Investigational Site
King of Prussia, Pennsylvania, United States, 19406
Status
Study Complete

Study documents

Clinical study report
Available language(s): English

If you wish to request for full study report, please contact - [email protected]

Results overview

Refer to study documents

Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2008-02-10

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

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Additional information
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