A Study of the Effects of Food and Age on Danicopan

NCT04551599 | Completed Phase 1 FDA Drug

• 1 other identifier: ACH471-016
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Factor D Inhibitor; Complement; Danicopan; Pharmacokinetics; Food-effect; Age-effect

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (1)

• 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)

Study Arms (3)

Part 1: Sequence 1

EXPERIMENTAL

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

Part 1: Sequence 2

EXPERIMENTAL

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

Part 2

EXPERIMENTAL

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

Drug: Danicopan

Interventions

Danicopan DRUG

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

Also known as: ACH-0144471, ALXN2040

Part 1: Sequence 1; Part 1: Sequence 2; Part 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexion Pharmaceuticals, Inc.: lead

Study Sites (1)

Clinical Trial Site

Tempe, Arizona, 85283, United States

Location

MeSH Terms

Interventions

danicopan

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This will be 2-part study. Part 1 will be a randomized, 2-sequence, 2-period crossover study, and Part 2 will be a 1-period study.

Study Record Dates

• First Submitted: September 10, 2020
• First Posted: September 16, 2020
• Study Start: February 21, 2020
• Primary Completion: February 3, 2021
• Study Completion: February 3, 2021
• Last Updated: January 13, 2023

Record last verified: 2023-01

Locations

US (1)