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A Safety and Pharmakokinetic Study of A4250 Alone or in Combination With A3384

NCT02963077 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2024-03-07

No results posted yet for this study

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

DRUG

A4250

DRUG

CRC (A3384)

DRUG

Questran

DRUG

Placebo

Sponsors & Collaborators

  • Albireo

    lead INDUSTRY

Principal Investigators

  • Ipsen Medical Director · Ipsen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2014-05-31
Completion
2014-05-31

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Drugs

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 NCT02963077 on ClinicalTrials.gov