Clinical trial NCT04609696: Study of the Metabolism of Danicopan in Healthy Adults
Official title: A 2-Part, Open-Label, Randomized, Single-Dose, 3-Period Crossover, Phase 1, Relative Bioavailability, and Food Effect Study, Comparing Different Formulations of Danicopan in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Tablet
Capsule
Danicopan
Bioavailability
Factor D Inhibitor
Food Effect
Lead sponsor: Alexion Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Celerion
First posted: 2020-10-30
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This is a 2-part open-label, randomized, single-dose, 3-sequence, 3-period crossover, relative bioavailability, and food-effect study comparing different formulations of danicopan in healthy adult participants.

Detailed description: For both parts of this study, on Day 1 of each period, participants will receive a single oral dose of danicopan as either the prototype powder-in-capsule (PIC) formulation (1 or 2) under fed conditions, the prototype PIC formulation (1 or 2) under fasting conditions, or the tablet formulation under fed conditions.

Eligibility criteria: Inclusion Criteria:

1. No clinically significant findings at screening (medical history, clinical laboratory profiles, and electrocardiograms).
2. 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.
3. Female participants of childbearing potential must either agree to abstinence or to use, with their male partner, a highly effective method of contraception .
4. Non-sterile male participants must agree to abstinence or use a highly effective method of contraception.

Exclusion Criteria:

1. 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.
2. History or presence of drug or alcohol abuse within previous 2 years, current tobacco user, or positive drugs-of-abuse screen or alcohol screen at screening or Day -1 of Period 1.
3. History of meningococcal infection, or a first-degree relative with a history of meningococcal infection.
4. History of procedures that could alter absorption or excretion of orally administered drugs.
5. History of significant multiple and/or severe allergies or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs.
6. Body temperature ≥ 38.0°Celcius at screening or prior to first dosing or history of febrile illness, or other evidence of infection, within 14 days prior to (first) dosing.
7. 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.
8. 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.
9. Is a female with a positive pregnancy test or who is lactating.

Primary outcomes:
measure: Relative Bioavailability Of Danicopan Prototype PIC 1 Formulation And Tablet Formulation
timeFrame: Up to 72 hours postdose
measure: AUC0-inf Of Danicopan Prototype PIC 1 Formulation Under Both Fed And Fasted Conditions
timeFrame: Up to 72 hours postdose
measure: AUC0-t Of Danicopan Prototype PIC 1 Formulation Under Both Fed And Fasted Conditions
timeFrame: Up to 72 hours postdose
measure: Cmax Of Danicopan Prototype PIC 1 Formulation Under Both Fed And Fasted Conditions
timeFrame: Up to 72 hours postdose
measure: Time to maximum observed plasma concentration (Tmax) Of Danicopan Prototype PIC 1 Formulation Under Both Fed And Fasted Conditions
timeFrame: Up to 72 hours postdose
measure: Relative Bioavailability Of Danicopan Prototype PIC 2 Formulation And Tablet Formulation
timeFrame: Up to 72 hours postdose
measure: AUC0-inf Of Danicopan Prototype PIC 2 Formulation Under Both Fed And Fasted Conditions
timeFrame: Up to 72 hours postdose
measure: AUC0-t Of Danicopan Prototype PIC 2 Formulation Under Both Fed And Fasted Conditions
timeFrame: Up to 72 hours postdose
measure: Cmax Of Danicopan Prototype PIC 2 Formulation Under Both Fed And Fasted Conditions
timeFrame: Up to 72 hours postdose
measure: Tmax Of Danicopan Prototype PIC 2 Formulation Under Both Fed And Fasted Conditions
timeFrame: Up to 72 hours postdose
Secondary outcomes:
measure: Number Of Participants Receiving Prototype PIC 1 And Tablet With Treatment-emergent Adverse Events Under Fed Conditions
timeFrame: Day 1 (postdose) through follow-up (10 [+/- 2] days dosing on Day 1)
measure: Number Of Participants Receiving Prototype PIC 1 With Treatment-emergent Adverse Events Under Fasted Conditions
timeFrame: Day 1 (postdose) through follow-up (10 [+/- 2] days dosing on Day 1)
measure: Number Of Participants Receiving Prototype PIC 2 And Tablet With Treatment-emergent Adverse Events Under Fed Conditions
timeFrame: Day 1 (postdose) through follow-up (10 [+/- 2] days dosing on Day 1)
measure: Number Of Participants Receiving Prototype PIC 2 With Treatment-emergent Adverse Events Under Fasted Conditions
timeFrame: Day 1 (postdose) through follow-up (10 [+/- 2] days dosing on Day 1)
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Clinical Trial Site
state: Arizona
Study officials:
References: