Trials / Completed
CompletedNCT04053023
Linerixibat and Obeticholic Acid Drug Interaction Study in Healthy Subjects
An Open-label, Single Sequence Crossover, Drug Interaction Study to Investigate the Effect of Linerixibat (GSK2330672) on Plasma Concentrations of Obeticholic Acid and Conjugates in Healthy Participants
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 19 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Accepted
Summary
In participants with inadequate response/intolerance to ursodeoxycholic acid (UDCA) taking obeticholic acid (OCA) who experience pruritus (due to primary biliary cholangitis \[PBC\], OCA, or both) the addition of linerixibat to OCA therapy may be considered following marketing approval. It is therefore important to characterize any potential effect of linerixibat on the pharmacokinetics of OCA in humans at clinically relevant dosages. Accordingly, a drug-drug interaction (DDI) study with linerixibat (potential perpetrator) and OCA (potential victim) will be conducted to inform both future clinical trials with linerixibat and the potential concomitant administration of these drugs in a clinical setting. This is a single-center, one part (with optional second part) open-label, single sequence crossover, drug interaction study to investigate the effect of linerixibat on plasma concentrations of OCA and OCA conjugates in healthy participants. Approximately 19 participants will be enrolled in part A and further 19 participants in part B (if performed) in the study and will have a phone call follow-up till 7-14 days post-last linerixibat dose.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | GSK2330672 (linerixibat) | GSK2330672 is available as a tablet with unit dose strength of 45 mg. |
| DRUG | Obeticholic acid | Obeticholic acid is available as a tablet with a unit dose strength of 10 mg (or 5 mg dependent on evaluation of Part A). |
Timeline
- Start date
- 2019-08-27
- Primary completion
- 2019-11-25
- Completion
- 2019-11-25
- First posted
- 2019-08-12
- Last updated
- 2020-07-24
- Results posted
- 2020-07-24
Locations
1 site across 1 country: United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04053023. Inclusion in this directory is not an endorsement.