A Drug Interaction Study of ACH-0145228
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT04709081
- Lead Sponsor
- Alexion Pharmaceuticals, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 38
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.
- No clinically significant history or presence of electrocardiogram abnormalities at screening and prior to first dosing in Period 1.
- Non-sterile male participants must agree to abstinence or use a highly effective method of contraception.
- Female participants must be of non-childbearing potential and need not employ a method of contraception.
Exclusion Criteria
- Clinically significant laboratory abnormalities.
- 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.
- 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.
- History or presence of clinically significant seizures, head injury, or head trauma.
- History of procedures that could alter absorption or excretion of orally administered drugs.
- A history of significant multiple and/or severe allergies or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs.
- Body temperature ≥ 38.0°Celsius at screening or prior to first dosing in Period 1.
- 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.
- 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.
- History or presence of any risk factors for Torsades de Pointes.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part 2: ACH-0145228 and Itraconazole ACH-0145228 Period 1: Participants received a single dose of ACH-0145228. Period 2: Participants received itraconazole once daily, in addition to coadministration with a single dose of ACH-0145228. Scheduled PK blood samples were collected, with a washout period of at least 2 days between collection of the last PK blood sample in Period 1 and the first dose of itraconazole in Period 2. Part 1: ACH-0145228, Midazolam, and Digoxin ACH-0145228 Period 1: Participants received single doses of midazolam and digoxin. Period 2: Participants received ACH-0145228 twice daily, in addition to coadministration with single doses of midazolam and digoxin. Scheduled pharmacokinetics (PK) blood and urine samples were collected, with a washout period of at least 7 days between collection of the last PK blood sample in Period 1 and the first dose of ACH-0145228 in Period 2. Part 1: ACH-0145228, Midazolam, and Digoxin Digoxin Period 1: Participants received single doses of midazolam and digoxin. Period 2: Participants received ACH-0145228 twice daily, in addition to coadministration with single doses of midazolam and digoxin. Scheduled pharmacokinetics (PK) blood and urine samples were collected, with a washout period of at least 7 days between collection of the last PK blood sample in Period 1 and the first dose of ACH-0145228 in Period 2. Part 1: ACH-0145228, Midazolam, and Digoxin Midazolam Period 1: Participants received single doses of midazolam and digoxin. Period 2: Participants received ACH-0145228 twice daily, in addition to coadministration with single doses of midazolam and digoxin. Scheduled pharmacokinetics (PK) blood and urine samples were collected, with a washout period of at least 7 days between collection of the last PK blood sample in Period 1 and the first dose of ACH-0145228 in Period 2. Part 2: ACH-0145228 and Itraconazole Itraconazole Period 1: Participants received a single dose of ACH-0145228. Period 2: Participants received itraconazole once daily, in addition to coadministration with a single dose of ACH-0145228. Scheduled PK blood samples were collected, with a washout period of at least 2 days between collection of the last PK blood sample in Period 1 and the first dose of itraconazole in Period 2.
- Primary Outcome Measures
Name Time Method 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 Up to 24 hours postdose Part 1: Time To Maximum Observed Concentration (Tmax) Of Single-dose Midazolam Under Multiple Doses Of ACH-0145228 Up to 24 hours postdose Part 2: Cmax Of Single-dose ACH-0145228 Under Multiple Doses Of Itraconazole Up to 96 hours postdose Part 1: Cmax Of Single-dose Digoxin Under Multiple Doses Of ACH-0145228 Up to 168 hours postdose Part 2: AUC0-inf Of Single-dose ACH-0145228 Under Multiple Doses Of Itraconazole Up to 96 hours postdose Part 1: Maximum Observed Concentration (Cmax) Of Single-dose Midazolam Under Multiple Doses Of ACH-0145228 Up to 24 hours postdose Part 1: AUC0-inf Of Single-dose Digoxin Under Multiple Doses Of ACH-0145228 Up to 168 hours postdose Part 1: Tmax Of Single-dose Digoxin Under Multiple Doses Of ACH-0145228 Up to 168 hours postdose Part 2: Tmax Of Single-dose ACH-0145228 Under Multiple Doses Of Itraconazole Up to 96 hours postdose
- Secondary Outcome Measures
Name Time Method Part 2: Number Of Participants With TEAEs After A Single Dose Of ACH-0145228 Coadministered With Multiple Doses Of Itraconazole Day 1 (postdose) through follow-up (14 [+/- 2] days after last study drug administration) Part 1: Number Of Participants With TEAEs After Multiple Doses Of ACH-0145228 Coadministered With A Single Dose Of Digoxin Day 1 (postdose) through follow-up (14 [+/- 2] days after last study drug administration) Part 1: Number Of Participants With Treatment-emergent Adverse Events (TEAEs) After Multiple Doses Of ACH-0145228 Coadministered With A Single Dose Of Midazolam Day 1 (postdose) through follow-up (14 [+/- 2] days after last study drug administration)
Trial Locations
- Locations (1)
Clinical Study Site
🇺🇸Tempe, Arizona, United States