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An Open Label, Single-dose, Single Period ADME Study of A4250 in Healthy Subjects

NCT03082937 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2024-03-07

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Albireo

    lead INDUSTRY

Principal Investigators

  • Ipsen Medical Director · Ipsen

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2017-03-08
Completion
2017-03-08

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03082937 on ClinicalTrials.gov