Clinical trial NCT04551599: A Study of the Effects of Food and Age on Danicopan
Official title: A Two-Part, Open-Label Phase 1 Study to Evaluate the Effect of Food and Age on the Pharmacokinetics of Danicopan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Factor D Inhibitor
Complement
Danicopan
Pharmacokinetics
Food-effect
Age-effect
Lead sponsor: Alexion Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2020-09-16
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: BASIC_SCIENCE

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.

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.

Primary outcomes:
measure: 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
timeFrame: Up to 72 hours postdose
measure: 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
timeFrame: Up to 72 hours postdose
measure: Maximum Observed Concentration (Cmax) Of Danicopan Under Both Fed And Fasted Conditions in Healthy Young Adults
timeFrame: Up to 72 hours postdose
measure: Time To Maximum Observed Concentration (Tmax) Of Danicopan Under Both Fed And Fasted Conditions in Healthy Young Adults
timeFrame: Up to 72 hours postdose
measure: AUC0-t Of Danicopan Under Fed Conditions In Healthy Elderly Males
timeFrame: Up to 72 hours postdose
measure: AUC0-inf Of Danicopan Under Fed Conditions In Healthy Elderly Males
timeFrame: Up to 72 hours postdose
measure: Cmax Of Danicopan Under Fed Conditions In Healthy Elderly Males
timeFrame: Up to 72 hours postdose
measure: Tmax Of Danicopan Under Fed Conditions In Healthy Elderly Males
timeFrame: Up to 72 hours postdose
Secondary outcomes:
measure: Number Of Healthy Young Adults And Healthy Elderly Males With Treatment-emergent Adverse Events
timeFrame: Day 1 (postdose) through follow-up (10 [+/- 2] days after last study drug administration)
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Clinical Trial Site
state: Arizona
Study officials:
References: