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This study aims to investigate the effect of linerixibat on plasma concentrations of obeticholic acid (OCA) and its conjugates in healthy adult participants to inform the potential for drug interaction with coadministration of linerixibat and OCA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm 1 | Experimental | Participants will receive OCA at dose level 1, 4 hours after the linerixibat administration |
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| Treatment Arm 2 | Experimental | Participants will receive OCA at dose level 2 along with linerixibat |
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| Treatment Arm 3 | Experimental | Participants will receive OCA at dose level 1 along with linerixibat |
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| Treatment Arm 4 | Experimental | Participants will receive OCA at dose level 2, 4 hours after the linerixibat administration |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Obeticholic acid | Drug | OCA will be administered |
|
| Measure | Description | Time Frame |
|---|---|---|
| Average trough concentration (Ctrough) in plasma for total-OCA at steady state | Days 35 to 38 |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration curve from time 0 to t (AUC0-t) for OCA, tauro-OCA, glyco-OCA and total-OCA at steady state | At Day 18 and Day 37 | |
| AUC from time 0 to 24 hour (AUC0-24) for OCA, tauro-OCA, glyco-OCA and total-OCA at steady state | Up to 24 hours on Day 18 and Day 37 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Baltimore | Maryland | 21225 | United States |
IPD for this study will be made available via the Clinical Study Data Request site.
IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study.
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
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| ID | Term |
|---|---|
| D011537 | Pruritus |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| C464660 | obeticholic acid |
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Two arms will be evaluated in parallel in Part A. After Part A, if Part B is conducted, one of the two remaining arms will be evaluated.
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| Linerixibat | Drug | Linerixibat will be administered |
|
| Maximum observed plasma concentration (Cmax) for OCA, tauro-OCA, glyco-OCA and total-OCA at steady state | At Day 18 and Day 37 |
| Average trough concentration (Ctrough) in plasma for OCA, tauro-OCA, glyco-OCA and total-OCA at steady state | Days 17 to 19 and Days 35 to 38 |
| Time to maximum concentration (Tmax) for OCA, tauro-OCA, glyco-OCA and total-OCA | At Day 18 and Day 37 |
| Ctrough of total OCA over Days 17 to 19 and Days 35 to 38 | Days 17 to 19 and Days 35 to 38 |
| Number of participants with adverse events | Up to Day 52 |
| D013568 | Pathological Conditions, Signs and Symptoms |