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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03108274
• Other study ID #: ACH471-010
• Secondary ID: U1111-1193-2774
• Status: Completed
• Phase: Phase 1
• Start date: April 18, 2017
• Est. completion date: June 16, 2017

Study information

• Verified date: June 2021
• Source: Alexion Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: June 16, 2017
• Est. primary completion date: June 2, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Key Inclusion Criteria:

• Healthy was defined as having no clinically relevant abnormalities identified by a detailed medical history, physical examination, blood pressure and heart rate measurements, 12-lead electrocardiogram, and clinical laboratory tests.

• Body mass index of 18.5 to 32 kilograms (kg)/square meter with a minimum body weight of 50 kg.

Key Exclusion Criteria:

• Mentally or legally incapacitated or significant emotional problems.

• Any condition that might interfere with drug absorption.

• History of sensitivity to study medication or other drug allergies.

• Body temperature greater than or equal to 38°Celsius on Day -1 or Day 1 predose; history of febrile illness within 14 days of the first dose.

• Positive urine drug test; current tobacco/nicotine users and smokers; consumption of alcohol within 72 hours of study drug administration.

• Participated in another clinical study within 28 days prior to the first dose.

• Significant laboratory abnormalities.

• Blood donation of more than 500 milliliters within 3 months of the first dose; received a blood transfusion or blood products within 6 months to the first dose.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Danicopan
Oral tablet.
• Midazolam
Oral syrup.
• Fexofenadine
Oral tablet.
• Mycophenolate Mofetil
Oral tablet.

Locations

Country	Name	City	State
New Zealand	Clinical Trial Site	Auckland

Sponsors (2)

Lead Sponsor	Collaborator
Alexion Pharmaceuticals	Achillion, a wholly owned subsidiary of Alexion

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part 1: Midazolam Area Under The Plasma Concentration-time Curve From Time 0 To The Time Of The Last Observed Non-zero Concentration (AUC0-t) Following Single-dose Midazolam Alone Versus In The Presence of Steady-state Danicopan		Up to 24 hours postdose
Primary	Part 1: Midazolam Area Under The Plasma Concentration-time Curve From Time 0 Extrapolated To Infinity (AUC0-inf) Following Single-dose Midazolam Alone Versus In The Presence of Steady-state Danicopan		Up to 24 hours postdose
Primary	Part 1: Midazolam Maximum Observed Plasma Concentration (Cmax) Following Single-dose Midazolam Alone Versus In The Presence of Steady-state Danicopan		Up to 24 hours postdose
Primary	Part 1: Midazolam Time To Reach Maximum Observed Plasma Concentration (Tmax) Following Single-dose Midazolam Alone Versus In The Presence of Steady-state Danicopan		Up to 24 hours postdose
Primary	Part 2: Fexofenadine AUC0-t Following Single-dose Fexofenadine Alone Versus In The Presence of Steady-state Danicopan		Up to 72 hours postdose
Primary	Part 2: Fexofenadine AUC0-inf Following Single-dose Fexofenadine Alone Versus In The Presence of Steady-state Danicopan		Up to 72 hours postdose
Primary	Part 2: Fexofenadine Cmax Following Single-dose Fexofenadine Alone Versus In The Presence of Steady-state Danicopan		Up to 72 hours postdose
Primary	Part 2: Fexofenadine Tmax Following Single-dose Fexofenadine Alone Versus In The Presence of Steady-state Danicopan		Up to 72 hours postdose
Primary	Part 3: Mycophenolic Acid (MPA) and Mycophenolic Acid Glucuronide (MPAG) AUC0-t Following Single-dose Mycophenolate Mofetil (MMF) Alone Versus In The Presence of Steady-state Danicopan		Up to 72 hours postdose
Primary	Part 3: MPA and MPAG AUC0-inf Following Single-dose MMF Alone Versus In The Presence of Steady-state Danicopan		Up to 72 hours postdose
Primary	Part 3: MPA and MPAG Cmax Following Single-dose MMF Alone Versus In The Presence of Steady-state Danicopan		Up to 72 hours postdose
Primary	Part 3: MPA and MPAG Tmax Following Single-dose MMF Alone Versus In The Presence of Steady-state Danicopan		Up to 72 hours postdose
Secondary	Parts 1-3: Participants Experiencing Treatment-emergent Adverse Events		7 (±1) days following the last dose in Period 2