Trials / Withdrawn
WithdrawnNCT02130661
Study to Determine the Effect of Itraconazole on the Pharmacokinetics of Rilapladib (SB659032) in Healthy Volunteers
A Phase I, Two-part, Open-label Study to Evaluate the Pharmacokinetics of Rilapladib (SB-659032) and Its Metabolites, and to Determine the Effect of Repeat Dose Itraconazole on the Pharmacokinetics of Rilapladib in Healthy Volunteers
- Status
- Withdrawn
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Accepted
Summary
Rilapladib is a potent and selective inhibitor of lipoprotein associated phospholipase A2 (Lp-PLA2), which was previously under development for the treatment of atherosclerosis and is currently being developed for the treatment of Alzheimer's disease. This study is a single-center, open-label, two-part study. The two study parts will run independently. Subjects dosed in one part of this study will not be permitted to participate in the other part. Part A will investigate the pharmacokinetic profile of rilapladib and its metabolites, SB-664601 and GSK1174379, after single dose and steady state dosing of rilapladib 250 milligram (mg) along with the biliary and urinary elimination pathways of rilapladib 250 mg. Part B will determine the effect of repeat administration of itraconazole on the PK of a single oral dose of rilapladib 25 mg. Healthy male and female subjects, aged 18-65 years, will be recruited for this study. Ten subjects will be recruited for Part A and 20 subjects will be recruited for Part B.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Rilapladib 25 mg | White, round, biconvex, film coated tablet of 25 mg. Taken orally along with food. |
| DRUG | Rilapladib 250 mg | White, round, biconvex, film coated tablet of 250 mg. Taken orally along with food. |
| DRUG | Itraconazole | 100 mg capsule with a blue opaque cap and pink transparent body. Taken orally along with food. |
Timeline
- Start date
- 2017-10-01
- Primary completion
- 2018-01-01
- Completion
- 2018-01-01
- First posted
- 2014-05-05
- Last updated
- 2016-12-13
Source: ClinicalTrials.gov record NCT02130661. Inclusion in this directory is not an endorsement.