A Study of the Effects of Food and Age on Danicopan

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Danicopan

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.

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tempe, Arizona, United States, 85283
      • Clinical Trial Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; A single dose of danicopan (200 milligrams) will be administered orally.; Other Names: ALXN2040; ACH-0144471
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; A single dose of danicopan (200 milligrams) will be administered orally.; Other Names: ALXN2040; ACH-0144471
Experimental: Part 2; Healthy, elderly, male participants will receive a single dose of danicopan under fed conditions.	Drug: Danicopan; A single dose of danicopan (200 milligrams) will be administered orally.; Other Names: ALXN2040; ACH-0144471

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Number Of Healthy Young Adults And Healthy Elderly Males With Treatment-emergent Adverse Events	Day 1 (postdose) through follow-up (10 [+/- 2] days after last study drug administration)

Collaborators and Investigators

• Sponsor: Alexion Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2020
• Primary Completion (Actual): February 3, 2021
• Study Completion (Actual): February 3, 2021

Study Registration Dates

• First Submitted: September 10, 2020
• First Submitted That Met QC Criteria: September 10, 2020
• First Posted (Actual): September 16, 2020

Study Record Updates

• Last Update Posted (Actual): January 13, 2023
• Last Update Submitted That Met QC Criteria: January 12, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Complement; Danicopan; Factor D Inhibitor; Food-effect; Age-effect
• Other Study ID Numbers: ACH471-016

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No