A Study of the Effects of Food and Age on Danicopan

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04551599
• Other study ID #: ACH471-016
• Status: Completed
• Phase: Phase 1
• Start date: February 21, 2020
• Est. completion date: February 3, 2021

Study information

• Verified date: January 2023
• Source: Alexion Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: February 3, 2021
• Est. primary completion date: February 3, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

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

Locations

Country	Name	City	State
United States	Clinical Trial Site	Tempe	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Alexion Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Maximum Observed Concentration (Cmax) Of Danicopan Under Both Fed And Fasted Conditions in Healthy Young Adults		Up to 72 hours postdose
Primary	Time To Maximum Observed Concentration (Tmax) Of Danicopan Under Both Fed And Fasted Conditions in Healthy Young Adults		Up to 72 hours postdose
Primary	AUC0-t Of Danicopan Under Fed Conditions In Healthy Elderly Males		Up to 72 hours postdose
Primary	AUC0-inf Of Danicopan Under Fed Conditions In Healthy Elderly Males		Up to 72 hours postdose
Primary	Cmax Of Danicopan Under Fed Conditions In Healthy Elderly Males		Up to 72 hours postdose
Primary	Tmax Of Danicopan Under Fed Conditions In Healthy Elderly Males		Up to 72 hours postdose
Secondary	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)