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NCT01154114

Study to Evaluate Darapladib in Moderately Hepatically Impaired Subjects

Completed Phase 1 Last updated 26 July 2017
What this trial tests

Phase 1 trial testing darapladib in Atherosclerosis in 24 participants. Completed in 15 October 2010.

Timeline
1 July 2010
Primary endpoint
15 October 2010
15 October 2010

Quick facts

Lead sponsorGlaxoSmithKline
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment24
Start date1 July 2010
Primary completion15 October 2010
Estimated completion15 October 2010
Sites2 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 18 to 65, any sex, with Atherosclerosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to determine any differences in pharmacokinetic parameters of darapladib when dosed to people with moderate liver disease as compared to when dosed in normal healthy volunteers.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. An effect of moderate hepatic impairment on the pharmacokinetics and safety of darapladib.
    Magee MH, Shearn S, Shaddinger B, Fang Z, et al · · 2014 · cited 4× · PMID 24938621 · DOI 10.1111/bcp.12436

Verify or expand the search:

Other recruiting trials for Atherosclerosis

Currently open trials in the same condition.

Other GlaxoSmithKline trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01154114.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing