Clinical trial NCT03108274: A Drug Interaction Study Between Danicopan and Midazolam, Fexofenadine, and Mycophenolate Mofetil in Healthy Participants
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Danicopan
ALXN2040
ACH-0144471
Midazolam
Fexofenadine
Mycophenolate Mofetil
Drug Interaction
Pharmacokinetics
Factor D Inhibitor
Safety
Lead sponsor: Alexion Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Achillion, a wholly owned subsidiary of Alexion
First posted: 2017-04-11
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Part 1, Part 2, and Part 3 could be conducted concurrently or separately, and the order of the parts could be determined according to the needs of the program.
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: Up to 24 hours postdose
measure: 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
timeFrame: Up to 24 hours postdose
measure: Part 1: Midazolam Maximum Observed Plasma Concentration (Cmax) Following Single-dose Midazolam Alone Versus In The Presence of Steady-state Danicopan
timeFrame: Up to 24 hours postdose
measure: Part 1: Midazolam Time To Reach Maximum Observed Plasma Concentration (Tmax) Following Single-dose Midazolam Alone Versus In The Presence of Steady-state Danicopan
timeFrame: Up to 24 hours postdose
measure: Part 2: Fexofenadine AUC0-t Following Single-dose Fexofenadine Alone Versus In The Presence of Steady-state Danicopan
timeFrame: Up to 72 hours postdose
measure: Part 2: Fexofenadine AUC0-inf Following Single-dose Fexofenadine Alone Versus In The Presence of Steady-state Danicopan
timeFrame: Up to 72 hours postdose
measure: Part 2: Fexofenadine Cmax Following Single-dose Fexofenadine Alone Versus In The Presence of Steady-state Danicopan
timeFrame: Up to 72 hours postdose
measure: Part 2: Fexofenadine Tmax Following Single-dose Fexofenadine Alone Versus In The Presence of Steady-state Danicopan
timeFrame: Up to 72 hours postdose
measure: 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
timeFrame: Up to 72 hours postdose
measure: Part 3: MPA and MPAG AUC0-inf Following Single-dose MMF Alone Versus In The Presence of Steady-state Danicopan
timeFrame: Up to 72 hours postdose
measure: Part 3: MPA and MPAG Cmax Following Single-dose MMF Alone Versus In The Presence of Steady-state Danicopan
timeFrame: Up to 72 hours postdose
measure: Part 3: MPA and MPAG Tmax Following Single-dose MMF Alone Versus In The Presence of Steady-state Danicopan
timeFrame: Up to 72 hours postdose
Secondary outcomes:
measure: Parts 1-3: Participants Experiencing Treatment-emergent Adverse Events
timeFrame: 7 (±1) days following the last dose in Period 2
Other outcomes:
Locations:
city: Auckland
country: New Zealand
facility: Clinical Trial Site
Study officials:
References: