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Completed

NCT Number: NCT04551599

A Study of the Effects of Food and Age on Danicopan

This will be an open-label, 2-part study. Part 1 will be a randomized, 2-sequence, 2-period crossover, food-effect study in healthy young adult participants. Part 2 will be a 1-period age-effect study in healthy elderly male participants.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Trial Site

Tempe, Arizona, 85283, United States

About this study

This will be an open-label, 2-part study. Part 1 will be a randomized, 2-sequence, 2-period crossover, food-effect study in healthy young adult participants. Part 2 will be a 1-period age-effect study in healthy elderly male participants.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Young adult males or females, between 18 and 55 years of age (Part 1 only).
  • Elderly male participants aged ≥ 65 years of age at screening (Part 2 only).
  • 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 findings at screening.
  • Non-sterile male participants must agree to abstinence or use a highly effective method of contraception.
  • Female participants of childbearing potential must either agree to abstinence or to use, with their male partner, a highly effective method of contraception (Part 1 only).

Exclusion criteria

  • Clinically significant laboratory abnormalities.
  • Pregnant or lactating (Part 1 only).
  • 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 user, and positive drugs-of-abuse or alcohol screen at screening or Day -1 of Period 1.
  • History of meningococcal infection, or a first-degree relative with a history of meningococcal infection.
  • Body temperature ≥ 38.0°Celsius at screening or prior to (first) dosing in Period 1 or history of febrile illness, or other evidence of infection, within 14 days prior to (first) dosing.
  • 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.
  • Major surgery within previous 4 weeks.
  • 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.
  • 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, or receipt of a vaccine within 30 days prior to (first) dosing.

Treatment and study plan

Danicopan

Drug

A single dose of danicopan (200 milligrams) will be administered orally.

Other names: ACH-0144471, ALXN2040

Primary outcomes

  1. Area Under The Concentration Versus Time Curve From Time 0 To The Last Measurable Concentration (AUC0-t) Of Danicopan Under Both Fed And Fasted Conditions In Healthy Young Adults

    Time frame: Up to 72 hours postdose

  2. Area Under The Concentration Versus Time Curve From Time 0 Extrapolated To Infinity (AUC0-inf) Of Danicopan Under Both Fed And Fasted Conditions In Healthy Young Adults

    Time frame: Up to 72 hours postdose

  3. Maximum Observed Concentration (Cmax) Of Danicopan Under Both Fed And Fasted Conditions in Healthy Young Adults

    Time frame: Up to 72 hours postdose

  4. Time To Maximum Observed Concentration (Tmax) Of Danicopan Under Both Fed And Fasted Conditions in Healthy Young Adults

    Time frame: Up to 72 hours postdose

  5. AUC0-t Of Danicopan Under Fed Conditions In Healthy Elderly Males

    Time frame: Up to 72 hours postdose

  6. AUC0-inf Of Danicopan Under Fed Conditions In Healthy Elderly Males

    Time frame: Up to 72 hours postdose

  7. Cmax Of Danicopan Under Fed Conditions In Healthy Elderly Males

    Time frame: Up to 72 hours postdose

  8. Tmax Of Danicopan Under Fed Conditions In Healthy Elderly Males

    Time frame: Up to 72 hours postdose

Secondary outcomes

  1. Number Of Healthy Young Adults And Healthy Elderly Males With Treatment-emergent Adverse Events

    Time frame: Day 1 (postdose) through follow-up (10 [+/- 2] days after last study drug administration)

Sponsors and collaborators

Lead sponsor

Alexion Pharmaceuticals, Inc.

Industry

Registry information

Official study title

A Two-Part, Open-Label Phase 1 Study to Evaluate the Effect of Food and Age on the Pharmacokinetics of Danicopan

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 16, 2020
Registry last updated
Jan 13, 2023

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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