A Drug Interaction Study Between Danicopan and Midazolam, Fexofenadine, and Mycophenolate Mofetil in Healthy Participants

NCT03108274 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2021-06-24

No results posted yet for this study

Summary

The purpose of this study was to determine the potential drug interaction between danicopan (ACH-0144471) and midazolam, fexofenadine, and mycophenolate mofetil. This was a 3-part study, with each part being an open-label, fixed-sequence, 2-treatment study in healthy adult participants.

Conditions

  • Healthy

Interventions

DRUG

Danicopan

Oral tablet.

DRUG

Midazolam

Oral syrup.

DRUG

Fexofenadine

Oral tablet.

DRUG

Mycophenolate Mofetil

Oral tablet.

Sponsors & Collaborators

  • Achillion, a wholly owned subsidiary of Alexion

    collaborator INDUSTRY
  • Alexion Pharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-04-18
Primary Completion
2017-06-02
Completion
2017-06-16
FDA Drug
Yes

Countries

  • New Zealand

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 NCT03108274 on ClinicalTrials.gov