NCT03108274

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

A Three-Part Phase 1 Study to Determine the Potential Drug Interaction Between ACH-0144471 and Midazolam, Fexofenadine and Mycophenolate Mofetil in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Alexion Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
DRUG	Danicopan	Oral tablet.
DRUG	Midazolam	Oral syrup.
DRUG	Fexofenadine	Oral tablet.
DRUG	Mycophenolate Mofetil	Oral tablet.

Timeline

• Start date: 2017-04-18
• Primary completion: 2017-06-02
• Completion: 2017-06-16
• First posted: 2017-04-11
• Last updated: 2021-06-24

Locations

1 site across 1 country: New Zealand

Regulatory

• FDA-regulated drug study