Healthy
Conditions
Keywords
Danicopan, ALXN2040, ACH-0144471, Drug Interaction, Cyclosporine, Tacrolimus, Antacids, Omeprazole
Brief summary
This was a 3-part study with each part being an open-label, fixed-sequence, 2-period study in healthy adult participants.
Interventions
DRUGDanicopan
Oral tablet.
DRUGCyclosporine
Oral capsule.
DRUGTacrolimus
Oral capsule.
DRUGCalcium Carbonate
Chewable tablet.
DRUGAluminum/Magnesium Hydroxide/Simethicone
Chewable tablet.
DRUGOmeprazole
Oral, delayed-release capsule.
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
This was a 3-part study, each part is a fixed-sequence with 2 periods.
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Key Inclusion Criteria: * Body mass index in the range of 18.0 to 32.0 kilograms (kg)/meter squared, inclusive, with a minimum body weight of 50.0 kg at Screening. * Female participants must have been of non-childbearing potential and not needing to employ a method of contraception. * Non-sterile male participants must have agreed to abstinence or used a highly effective method of contraception. * No clinically significant history or presence of electrocardiogram findings at Screening and Day -1 of Period 1. Key
Exclusion criteria
* Evidence of any clinically significant deviation from normal in clinical laboratory evaluations. * History of any medical or psychiatric condition or disease that might have limited the participant's ability to complete or participate in this clinical study, confound the results of the study, or pose an additional risk to the participant by their participation in the study. * History or presence of drug or alcohol abuse within 2 years prior to first dosing; current tobacco/nicotine users and smokers; positive drugs-of-abuse and/or alcohol screen at Screening or Day -1 of Period 1. * Any previous procedure that could have altered absorption or excretion of orally administered drugs. * A history of significant multiple and/or severe allergies or had had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs. * Body temperature ≥ 38°Celsius at Screening, on Day -1, or Day 1 prior to first dosing; history of febrile illness, or other evidence of infection, within 14 days prior to first dosing. * Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 5 half-lives (if known) or 30 days before first dosing, whichever was longer. * Donation of whole blood from 3 months prior to first dosing, or of plasma from 30 days before first dosing; receipt of blood products within 6 months prior to first dosing. * Part 3 Only: Genotyped as poor metabolizer of cytochrome P450 2C19.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part 3: Steady-state Danicopan AUC0-8 Alone Versus In The Presence Of Single-dose Calcium Carbonate Or Aluminum/Magnesium Hydroxide/Simethicone | Up to 8 hours postdose |
| Part 1: Cyclosporine Maximum Observed Concentration (Cmax) Following Single-dose Cyclosporine Alone Versus In The Presence Of Steady-state Danicopan | Up to 72 hours postdose |
| Part 1: Cyclosporine Time To Reach The Maximum Observed Concentration (Tmax) Following Single-dose Cyclosporine Alone Versus In The Presence Of Steady-state Danicopan | Up to 72 hours postdose |
| Part 1: Cyclosporine Area Under The Concentration-time Curve From Time 0 Extrapolated To Infinity (AUC0-inf) Following Single-dose Cyclosporine Alone Versus In The Presence Of Steady-state Danicopan | Up to 72 hours postdose |
| Part 2: Tacrolimus Cmax Following Single-dose Tacrolimus Alone Versus In The Presence Of Steady-state Danicopan | Up to 144 hours postdose |
| Part 2: Tacrolimus Tmax Following Single-dose Tacrolimus Alone Versus In The Presence Of Steady-state Danicopan | Up to 144 hours postdose |
| Part 2: Tacrolimus AUC0-inf Following Single-dose Tacrolimus Alone Versus In The Presence Of Steady-state Danicopan | Up to 144 hours postdose |
| Part 3: Steady-state Omeprazole Cmax Following Multiple-dose Omeprazole Alone Versus In The Presence Of Steady-state Danicopan | Up to 24 hours postdose |
| Part 3: Steady-state Omeprazole Tmax Following Multiple-dose Omeprazole Alone Versus In The Presence Of Steady-state Danicopan | Up to 24 hours postdose |
| Part 3: Steady-state Omeprazole Area Under The Concentration-time Curve From Time 0 To The 24-hour Time Point (AUC0-24) Following Multiple-dose Omeprazole Alone Versus In The Presence Of Steady-state Danicopan | Up to 24 hours postdose |
| Part 3: Steady-state Danicopan Cmax Alone Versus In The Presence Of Multiple-dose Omeprazole | Up to 8 hours postdose |
| Part 3: Steady-state Danicopan Tmax Alone Versus In The Presence Of Multiple-dose Omeprazole | Up to 8 hours postdose |
| Part 3: Steady-state Danicopan Area Under The Concentration-time Curve From Time 0 To The 8-hour Time Point (AUC0-8) Alone Versus In The Presence Of Multiple-dose Omeprazole | Up to 8 hours postdose |
| Part 3: Steady-state Danicopan Cmax Alone Versus In The Presence Of Single-dose Calcium Carbonate Or Aluminum/Magnesium Hydroxide/Simethicone | Up to 8 hours postdose |
| Part 3: Steady-state Danicopan Tmax Alone Versus In The Presence Of Single-dose Calcium Carbonate Or Aluminum/Magnesium Hydroxide/Simethicone | Up to 8 hours postdose |
Secondary
| Measure | Time frame |
|---|---|
| Number Of Participants Experiencing Treatment-emergent Adverse Events | Day 1 through up to Day 31 |
Countries
United States
Outcome results
None listed