Trials / Completed
CompletedNCT03082937
An Open Label, Single-dose, Single Period ADME Study of A4250 in Healthy Subjects
An Open Label, Single-Dose, Single Period Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-A4250 in Healthy Male Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 6 (actual)
- Sponsor
- Albireo · Industry
- Sex
- Male
- Age
- 30 Years – 65 Years
- Healthy volunteers
- Accepted
Summary
The primary objectives of the study are to assess the mass balance recovery after a single dose of carbon-14 \[14C\]-A4250 as a capsule and to provide plasma, urine and faecal samples for metabolite profiling and structural identification in healthy male subjects.
Conditions
- Orphan Cholestatic Liver Diseases
- Progressive Familial Intrahepatic Cholestasis
- Alagille Syndrome
- Primary Biliary Cirrhosis
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 3 mg [14C]-A4250 capsule | Each subject will receive a single administration of 3 mg \[14C\]-A4250 capsule for oral administration containing not more than 4.3 MBq (116 μCi), in the fasted state. |
Timeline
- Start date
- 2017-01-31
- Primary completion
- 2017-03-08
- Completion
- 2017-03-08
- First posted
- 2017-03-17
- Last updated
- 2024-03-07
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT03082937. Inclusion in this directory is not an endorsement.