Trials / Completed
CompletedNCT02963077
A Safety and Pharmakokinetic Study of A4250 Alone or in Combination With A3384
A Phase I, Double-Blind Single and Multiple Ascending Dose Study to Assess Safety and Pharmacokinetics of A4250 as Monotherapy, and in Combination With Colonic Release Cholestyramine (A3384) or Commercially Available Cholestyramine (Questran™) in Healthy Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 94 (actual)
- Sponsor
- Albireo · Industry
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Accepted
Summary
The primary objectives of the study are to evaluate the safety, tolerability and pharmacokinetics of A4250 after single or multiple oral doses in healthy subjects. In addition, will evaluate A4250 in combination with cholestyramine.
Conditions
- Orphan Cholestatic Liver Diseases
- Primary Biliary Cirrhosis
- Progressive Familial Intrahepatic Cholestasis
- Alagille Syndrome
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | A4250 | |
| DRUG | CRC (A3384) | |
| DRUG | Questran | |
| DRUG | Placebo |
Timeline
- Start date
- 2013-07-01
- Primary completion
- 2014-05-01
- Completion
- 2014-05-01
- First posted
- 2016-11-15
- Last updated
- 2024-03-07
Source: ClinicalTrials.gov record NCT02963077. Inclusion in this directory is not an endorsement.