A Study of the Effects of Food and Age on Danicopan

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2021

Interventions

  • Drug: Danicopan
    • A single dose of danicopan (200 milligrams) will be administered orally.

Arms, Groups and Cohorts

  • 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.
  • 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.
  • Experimental: Part 2
    • Healthy, elderly, male participants will receive a single dose of danicopan under fed conditions.

Clinical Trial Outcome Measures

Primary Measures

  • 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
  • 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
  • Maximum Observed Concentration (Cmax) Of Danicopan Under Both Fed And Fasted Conditions in Healthy Young Adults
    • Time Frame: Up to 72 hours postdose
  • 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
  • AUC0-t Of Danicopan Under Fed Conditions In Healthy Elderly Males
    • Time Frame: Up to 72 hours postdose
  • AUC0-inf Of Danicopan Under Fed Conditions In Healthy Elderly Males
    • Time Frame: Up to 72 hours postdose
  • Cmax Of Danicopan Under Fed Conditions In Healthy Elderly Males
    • Time Frame: Up to 72 hours postdose
  • Tmax Of Danicopan Under Fed Conditions In Healthy Elderly Males
    • Time Frame: Up to 72 hours postdose

Secondary Measures

  • 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)

Participating in This Clinical Trial

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

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Alexion Pharmaceuticals
  • Collaborator
    • Celerion
  • Provider of Information About this Clinical Study
    • Sponsor

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.