A Study of the Effects of Food and Age on Danicopan

NCT ID: NCT04551599

Last Updated: 2023-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-21
• Study Completion Date: 2021-02-03

Brief 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.

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Danicopan

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

Danicopan

Intervention Type: DRUG

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

Part 2

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

Group Type: EXPERIMENTAL

Danicopan

Intervention Type: DRUG

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

Interventions

Danicopan

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

Intervention Type: DRUG

Other Intervention Names

ACH-0144471; ALXN2040

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Alexion Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinical Trial Site

Tempe, Arizona, United States

Countries

United States

Other Identifiers

ACH471-016

Identifier Type: -

Identifier Source: org_study_id