Clinical trial NCT04709081: A Drug Interaction Study of ACH-0145228
Official title: A Two-Part Phase 1 Study to Evaluate the Potential Drug Interaction Between ACH-0145228 and Midazolam, Digoxin, and Itraconazole in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Factor D Inhibitor
Complement
Capsule
Pharmacokinetics
Drug Interaction
Lead sponsor: Alexion Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Achillion, a wholly owned subsidiary of Alexion
name: Celerion
First posted: 2021-01-14
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Part 1 and Part 2 could be conducted concurrently or separately.
Primary purpose: BASIC_SCIENCE

Brief summary: This was a 2-part study (Part 1 and Part 2), with each part being an open-label, fixed sequence, 2-period study in healthy adult participants.


Eligibility criteria: Inclusion Criteria:

1. 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.
2. No clinically significant history or presence of electrocardiogram abnormalities at screening and prior to first dosing in Period 1.
3. Non-sterile male participants must agree to abstinence or use a highly effective method of contraception.
4. Female participants must be of non-childbearing potential and need not employ a method of contraception.

Exclusion Criteria:

1. Clinically significant laboratory abnormalities.
2. History of any medical or psychiatric condition or disease that might limit 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.
3. History or presence of drug or alcohol abuse within previous 2 years, current tobacco/nicotine user, or positive for alcohol and/or drug screen at screening or Day -1 of Period 1.
4. History or presence of clinically significant seizures, head injury, or head trauma.
5. History of procedures that could alter absorption or excretion of orally administered drugs.
6. A history of significant multiple and/or severe allergies or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs.
7. Body temperature ≥ 38.0°Celsius at screening or prior to first dosing in Period 1.
8. Donation of whole blood from 3 months prior to first dosing, or of plasma from 30 days before first dosing, or receipt of blood products within 6 months prior to first dosing.
9. 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 is longer.
10. History or presence of any risk factors for Torsades de Pointes.

Primary outcomes:
measure: Part 1: Area Under The Concentration Versus Time Curve From Time 0 Extrapolated To Infinity (AUC0-inf) Of Single-dose Midazolam Under Multiple Doses Of ACH-0145228
timeFrame: Up to 24 hours postdose
measure: Part 1: Maximum Observed Concentration (Cmax) Of Single-dose Midazolam Under Multiple Doses Of ACH-0145228
timeFrame: Up to 24 hours postdose
measure: Part 1: Time To Maximum Observed Concentration (Tmax) Of Single-dose Midazolam Under Multiple Doses Of ACH-0145228
timeFrame: Up to 24 hours postdose
measure: Part 1: AUC0-inf Of Single-dose Digoxin Under Multiple Doses Of ACH-0145228
timeFrame: Up to 168 hours postdose
measure: Part 1: Cmax Of Single-dose Digoxin Under Multiple Doses Of ACH-0145228
timeFrame: Up to 168 hours postdose
measure: Part 1: Tmax Of Single-dose Digoxin Under Multiple Doses Of ACH-0145228
timeFrame: Up to 168 hours postdose
measure: Part 2: AUC0-inf Of Single-dose ACH-0145228 Under Multiple Doses Of Itraconazole
timeFrame: Up to 96 hours postdose
measure: Part 2: Cmax Of Single-dose ACH-0145228 Under Multiple Doses Of Itraconazole
timeFrame: Up to 96 hours postdose
measure: Part 2: Tmax Of Single-dose ACH-0145228 Under Multiple Doses Of Itraconazole
timeFrame: Up to 96 hours postdose
Secondary outcomes:
measure: Part 1: Number Of Participants With Treatment-emergent Adverse Events (TEAEs) After Multiple Doses Of ACH-0145228 Coadministered With A Single Dose Of Midazolam
timeFrame: Day 1 (postdose) through follow-up (14 [+/- 2] days after last study drug administration)
measure: Part 1: Number Of Participants With TEAEs After Multiple Doses Of ACH-0145228 Coadministered With A Single Dose Of Digoxin
timeFrame: Day 1 (postdose) through follow-up (14 [+/- 2] days after last study drug administration)
measure: Part 2: Number Of Participants With TEAEs After A Single Dose Of ACH-0145228 Coadministered With Multiple Doses Of Itraconazole
timeFrame: Day 1 (postdose) through follow-up (14 [+/- 2] days after last study drug administration)
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Clinical Study Site
state: Arizona
Study officials:
References: