Healthy
Conditions
Keywords
Danicopan, ALXN2040, ACH-0144471, Midazolam, Fexofenadine, Mycophenolate Mofetil, Drug Interaction, Pharmacokinetics, Factor D Inhibitor, Safety
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.
Interventions
DRUGDanicopan
Oral tablet.
DRUGMidazolam
Oral syrup.
DRUGFexofenadine
Oral tablet.
DRUGMycophenolate Mofetil
Oral tablet.
Sponsors
Achillion, a wholly owned subsidiary of Alexion
Alexion Pharmaceuticals, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part 3: MPA and MPAG Tmax Following Single-dose MMF Alone Versus In The Presence of Steady-state Danicopan | Up to 72 hours postdose |
| 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 |
| 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 |
| 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 |
| 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 |
| Part 2: Fexofenadine AUC0-t Following Single-dose Fexofenadine Alone Versus In The Presence of Steady-state Danicopan | Up to 72 hours postdose |
| Part 2: Fexofenadine AUC0-inf Following Single-dose Fexofenadine Alone Versus In The Presence of Steady-state Danicopan | Up to 72 hours postdose |
| Part 2: Fexofenadine Cmax Following Single-dose Fexofenadine Alone Versus In The Presence of Steady-state Danicopan | Up to 72 hours postdose |
| Part 2: Fexofenadine Tmax Following Single-dose Fexofenadine Alone Versus In The Presence of Steady-state Danicopan | Up to 72 hours postdose |
| 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 |
| 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 |
| Part 3: MPA and MPAG Cmax Following Single-dose MMF Alone Versus In The Presence of Steady-state Danicopan | Up to 72 hours postdose |
Secondary
| Measure | Time frame |
|---|---|
| Parts 1-3: Participants Experiencing Treatment-emergent Adverse Events | 7 (±1) days following the last dose in Period 2 |
Countries
New Zealand
Outcome results
None listed