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Completed

NCT Number: NCT04709081

A Drug Interaction Study of ACH-0145228

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.

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Study Site

Tempe, Arizona, 85283, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ACH-0145228

Drug

ACH-0145228 was dosed as 2 x 60 milligram (mg) (Part 1) or 1 x 40 mg (Part 2) powder in capsules.

Other names: ALXN2050

midazolam

Drug

Midazolam was dosed at 2 mg (1 milliliter [mL] of a 2 mg/mL syrup).

Other names: Midazolam HCl

Digoxin

Drug

Digoxin was dosed as Lanoxin (or generic equivalent) at 1 x 0.25 mg tablet.

Other names: Lanoxin

Itraconazole

Drug

Itraconazole was dosed as Sporanox (or generic equivalent) at 200 mg (20 mL of a 10 mg/mL oral solution).

Other names: Sporanox

Primary outcomes

  1. 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

    Time frame: Up to 24 hours postdose

  2. Part 1: Maximum Observed Concentration (Cmax) Of Single-dose Midazolam Under Multiple Doses Of ACH-0145228

    Time frame: Up to 24 hours postdose

  3. Part 1: Time To Maximum Observed Concentration (Tmax) Of Single-dose Midazolam Under Multiple Doses Of ACH-0145228

    Time frame: Up to 24 hours postdose

  4. Part 1: AUC0-inf Of Single-dose Digoxin Under Multiple Doses Of ACH-0145228

    Time frame: Up to 168 hours postdose

  5. Part 1: Cmax Of Single-dose Digoxin Under Multiple Doses Of ACH-0145228

    Time frame: Up to 168 hours postdose

  6. Part 1: Tmax Of Single-dose Digoxin Under Multiple Doses Of ACH-0145228

    Time frame: Up to 168 hours postdose

  7. Part 2: AUC0-inf Of Single-dose ACH-0145228 Under Multiple Doses Of Itraconazole

    Time frame: Up to 96 hours postdose

  8. Part 2: Cmax Of Single-dose ACH-0145228 Under Multiple Doses Of Itraconazole

    Time frame: Up to 96 hours postdose

  9. Part 2: Tmax Of Single-dose ACH-0145228 Under Multiple Doses Of Itraconazole

    Time frame: Up to 96 hours postdose

Secondary outcomes

  1. Part 1: Number Of Participants With Treatment-emergent Adverse Events (TEAEs) After Multiple Doses Of ACH-0145228 Coadministered With A Single Dose Of Midazolam

    Time frame: Day 1 (postdose) through follow-up (14 [+/- 2] days after last study drug administration)

  2. Part 1: Number Of Participants With TEAEs After Multiple Doses Of ACH-0145228 Coadministered With A Single Dose Of Digoxin

    Time frame: Day 1 (postdose) through follow-up (14 [+/- 2] days after last study drug administration)

  3. Part 2: Number Of Participants With TEAEs After A Single Dose Of ACH-0145228 Coadministered With Multiple Doses Of Itraconazole

    Time frame: Day 1 (postdose) through follow-up (14 [+/- 2] days after last study drug administration)

Sponsors and collaborators

Lead sponsor

Alexion Pharmaceuticals, Inc.

Industry

Collaborators

  • Achillion, a wholly owned subsidiary of Alexion
  • Celerion

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 14, 2021
Registry last updated
Jan 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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