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CompletedNCT04551599Updated Jan 13, 2023

A Study of the Effects of Food and Age on Danicopan

A Phase 1 interventional study of Danicopan in Healthy, sponsored by Alexion Pharmaceuticals, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-01-13.

Sponsored by Alexion Pharmaceuticals, Inc. · Phase 1, Interventional, and Basic science

From the registry’s dates

  • Primary completion was Feb 2021, 5 years 8 months ago, and no results have been posted to the registry.
  • Registered 6 months after the study started (first participant enrolled Feb 2020, registered Sep 2020).
Phase
Phase 1
Study type
Interventional
Enrollment
27
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Healthy

Keywords

  • Factor D Inhibitor
  • Complement
  • Danicopan
  • Pharmacokinetics
  • Food-effect
  • Age-effect
03

In context

Lead sponsor

Alexion Pharmaceuticals, Inc. is the lead sponsor of 249 studies on the registry; 25 are open to participants now.

Of its 98 completed or terminated interventional studies of FDA-regulated products, 70 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Young adult males or females, between 18 and 55 years of age (Part 1 only).
  2. Elderly male participants aged ≥ 65 years of age at screening (Part 2 only).
  3. 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.
  4. No clinically significant history or presence of electrocardiogram findings at screening.
  5. Non-sterile male participants must agree to abstinence or use a highly effective method of contraception.
  6. 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

Exclusion Criteria:

  1. Clinically significant laboratory abnormalities.
  2. Pregnant or lactating (Part 1 only).
  3. 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.
  4. 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.
  5. History of meningococcal infection, or a first-degree relative with a history of meningococcal infection.
  6. 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.
  7. History of procedures that could alter absorption or excretion of orally administered drugs.
  8. A history of significant multiple and/or severe allergies or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs.
  9. Major surgery within previous 4 weeks.
  10. 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.
  11. 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.
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
27 participants (actual)

Study arms

  • Experimental
    Part 1: Sequence 1

    Healthy, young, adult participants will receive danicopan once each Period as follows: Period 1: Danicopan administered under fed conditions. Period 2: Danicopan administered under fasted conditions. There will be a washout period of at least 7 days between the dose of danicopan in Period 1 and the dose of danicopan in Period 2.

    Drug: Danicopan

  • Experimental
    Part 1: Sequence 2

    Healthy, young, adult participants will receive danicopan once each Period as follows: Period 1: Danicopan administered under fasted conditions. Period 2: Danicopan administered under fed conditions. There will be a washout period of at least 7 days between the dose of danicopan in Period 1 and the dose of danicopan in Period 2.

    Drug: Danicopan

  • Experimental
    Part 2

    Healthy, elderly, male participants will receive a single dose of danicopan under fed conditions.

    Drug: Danicopan

Interventions

  • DrugDanicopan

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

    Also known as: ACH-0144471, ALXN2040

06

What researchers measure

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)

07

Study locations

1 site
  • Clinical Trial Site
    Tempe, Arizona 85283, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04551599
Lead sponsor
Alexion Pharmaceuticals, Inc.
Responsible party
Sponsor
First posted
Sep 16, 2020
Start date
Feb 21, 2020
Primary completion
Feb 3, 2021
Completion
Feb 3, 2021
Last update
Jan 13, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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