A Drug Interaction Study of ACH-0145228

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04709081
• Other study ID #: ACH228-003
• Secondary ID: CA28776
• Status: Completed
• Phase: Phase 1
• Start date: December 22, 2019
• Est. completion date: April 16, 2020

Study information

• Verified date: January 2021
• Source: Alexion Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: April 16, 2020
• Est. primary completion date: April 16, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• ACH-0145228
ACH-0145228 was dosed as 2 x 60 milligram (mg) (Part 1) or 1 x 40 mg (Part 2) powder in capsules.
• Midazolam
Midazolam was dosed at 2 mg (1 milliliter [mL] of a 2 mg/mL syrup).
• Digoxin
Digoxin was dosed as Lanoxin (or generic equivalent) at 1 x 0.25 mg tablet.
• Itraconazole
Itraconazole was dosed as Sporanox (or generic equivalent) at 200 mg (20 mL of a 10 mg/mL oral solution).

Locations

Country	Name	City	State
United States	Clinical Study Site	Tempe	Arizona

Sponsors (3)

Lead Sponsor	Collaborator
Alexion Pharmaceuticals	Achillion, a wholly owned subsidiary of Alexion, Celerion

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Part 1: Maximum Observed Concentration (Cmax) Of Single-dose Midazolam Under Multiple Doses Of ACH-0145228		Up to 24 hours postdose
Primary	Part 1: Time To Maximum Observed Concentration (Tmax) Of Single-dose Midazolam Under Multiple Doses Of ACH-0145228		Up to 24 hours postdose
Primary	Part 1: AUC0-inf Of Single-dose Digoxin Under Multiple Doses Of ACH-0145228		Up to 168 hours postdose
Primary	Part 1: Cmax Of Single-dose Digoxin Under Multiple Doses Of ACH-0145228		Up to 168 hours postdose
Primary	Part 1: Tmax Of Single-dose Digoxin Under Multiple Doses Of ACH-0145228		Up to 168 hours postdose
Primary	Part 2: AUC0-inf Of Single-dose ACH-0145228 Under Multiple Doses Of Itraconazole		Up to 96 hours postdose
Primary	Part 2: Cmax Of Single-dose ACH-0145228 Under Multiple Doses Of Itraconazole		Up to 96 hours postdose
Primary	Part 2: Tmax Of Single-dose ACH-0145228 Under Multiple Doses Of Itraconazole		Up to 96 hours postdose
Secondary	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)
Secondary	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)
Secondary	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)