Skip to main content
OpenTrials
Completed

NCT Number: NCT05109390

A Study of the Drug Interactions Between Danicopan and Cyclosporine, Tacrolimus, Antacids, and Omeprazole in Healthy Adults

This was a 3-part study with each part being an open-label, fixed-sequence, 2-period study in healthy adult participants.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Trial Site

Tempe, Arizona, 85283, United States

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Danicopan

Drug

Oral tablet.

Other names: ALXN2040, ACH-0144471 (formerly), ACH-4471, ACH4471, 4471

cyclosporine

Drug

Oral capsule.

Other names: Neoral

Tacrolimus

Drug

Oral capsule.

Other names: Prograf

Calcium Carbonate

Drug

Chewable tablet.

Other names: Antacid

Aluminum/Magnesium Hydroxide/Simethicone

Drug

Chewable tablet.

Other names: Antacid, Gelusil

Omeprazole

Drug

Oral, delayed-release capsule.

Other names: Prilosec

Primary outcomes

  1. Part 1: Cyclosporine Maximum Observed Concentration (Cmax) Following Single-dose Cyclosporine Alone Versus In The Presence Of Steady-state Danicopan

    Time frame: Up to 72 hours postdose

  2. Part 1: Cyclosporine Time To Reach The Maximum Observed Concentration (Tmax) Following Single-dose Cyclosporine Alone Versus In The Presence Of Steady-state Danicopan

    Time frame: Up to 72 hours postdose

  3. 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

    Time frame: Up to 72 hours postdose

  4. Part 2: Tacrolimus Cmax Following Single-dose Tacrolimus Alone Versus In The Presence Of Steady-state Danicopan

    Time frame: Up to 144 hours postdose

  5. Part 2: Tacrolimus Tmax Following Single-dose Tacrolimus Alone Versus In The Presence Of Steady-state Danicopan

    Time frame: Up to 144 hours postdose

  6. Part 2: Tacrolimus AUC0-inf Following Single-dose Tacrolimus Alone Versus In The Presence Of Steady-state Danicopan

    Time frame: Up to 144 hours postdose

  7. Part 3: Steady-state Omeprazole Cmax Following Multiple-dose Omeprazole Alone Versus In The Presence Of Steady-state Danicopan

    Time frame: Up to 24 hours postdose

  8. Part 3: Steady-state Omeprazole Tmax Following Multiple-dose Omeprazole Alone Versus In The Presence Of Steady-state Danicopan

    Time frame: Up to 24 hours postdose

  9. 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

    Time frame: Up to 24 hours postdose

  10. Part 3: Steady-state Danicopan Cmax Alone Versus In The Presence Of Multiple-dose Omeprazole

    Time frame: Up to 8 hours postdose

  11. Part 3: Steady-state Danicopan Tmax Alone Versus In The Presence Of Multiple-dose Omeprazole

    Time frame: Up to 8 hours postdose

  12. 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

    Time frame: Up to 8 hours postdose

  13. Part 3: Steady-state Danicopan Cmax Alone Versus In The Presence Of Single-dose Calcium Carbonate Or Aluminum/Magnesium Hydroxide/Simethicone

    Time frame: Up to 8 hours postdose

  14. Part 3: Steady-state Danicopan Tmax Alone Versus In The Presence Of Single-dose Calcium Carbonate Or Aluminum/Magnesium Hydroxide/Simethicone

    Time frame: Up to 8 hours postdose

  15. Part 3: Steady-state Danicopan AUC0-8 Alone Versus In The Presence Of Single-dose Calcium Carbonate Or Aluminum/Magnesium Hydroxide/Simethicone

    Time frame: Up to 8 hours postdose

Secondary outcomes

  1. Number Of Participants Experiencing Treatment-emergent Adverse Events

    Time frame: Day 1 through up to Day 31

Sponsors and collaborators

Lead sponsor

Alexion Pharmaceuticals, Inc.

Industry

Collaborators

  • Achillion, a wholly owned subsidiary of Alexion

Registry information

Official study title

A Three-Part Phase 1 Study to Evaluate the Potential Drug Interaction Between ACH-0144471 and Cyclosporine, Tacrolimus, Antacids, and Omeprazole in Healthy Adult Subjects

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Nov 5, 2021
Registry last updated
Nov 5, 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.

Published trials that share one or more normalized conditions with this study.