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Study of A4250 in Healthy Volunteers Under Fasting, Fed and Sprinkled Conditions

NCT03608319 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2024-03-07

No results posted yet for this study

Summary

The primary objective of this study is to determine the single-dose pharmacokinetics (PK) of A4250 when administered after a high-fat meal and when sprinkled on applesauce in healthy adult subjects.

Conditions

  • Healthy Volunteers

Interventions

DRUG

A4250

9.6 mg

Sponsors & Collaborators

  • Celerion

    collaborator INDUSTRY

  • Albireo

    lead INDUSTRY

Principal Investigators

  • Ipsen Medical Director · Ipsen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-07-05
Primary Completion
2018-08-05
Completion
2018-08-18
FDA Drug
Yes

Countries

  • United States

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 NCT03608319 on ClinicalTrials.gov