- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04609696
Study of the Metabolism of Danicopan in Healthy Adults
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 Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Arizona
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Tempe, Arizona, United States, 85283
- Clinical Trial Site
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- No clinically significant findings at screening (medical history, clinical laboratory profiles, and electrocardiograms).
- 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.
- Female participants of childbearing potential must either agree to abstinence or to use, with their male partner, a highly effective method of contraception .
- Non-sterile male participants must agree to abstinence or use a highly effective method of contraception.
Exclusion Criteria:
- 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, or positive drugs-of-abuse screen 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.
- History of procedures that could alter absorption or excretion of orally administered drugs.
- History of significant multiple and/or severe allergies or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs.
- 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.
- 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.
- Is a female with a positive pregnancy test or who is lactating.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Part 1: Sequence 1
Participants will receive danicopan once each period as a single oral dose under fasted or fed conditions as follows: Period 1: Danicopan as the PIC 1 formulation under fed conditions. Period 2: Danicopan as the PIC 1 formulation under fasted conditions. Period 3: Danicopan as a tablet under fed conditions. There will be a washout period of at least 5 days between each danicopan dosing. |
Danicopan (200 milligrams) will be administered orally on Day 1.
Other Names:
Danicopan (200 milligrams) will be administered orally on Day 1.
Other Names:
|
Experimental: Part 1: Sequence 2
Participants will receive danicopan once each period as a single oral dose under fasted or fed conditions as follows: Period 1: Danicopan as the PIC 1 formulation under fasted conditions. Period 2: Danicopan as a tablet under fed conditions. Period 3: Danicopan as the PIC 1 formulation under fed conditions. There will be a washout period of at least 5 days between each danicopan dosing. |
Danicopan (200 milligrams) will be administered orally on Day 1.
Other Names:
Danicopan (200 milligrams) will be administered orally on Day 1.
Other Names:
|
Experimental: Part 1: Sequence 3
Participants will receive danicopan once each period as a single oral dose under fasted or fed conditions as follows: Period 1: Danicopan as a tablet under fed conditions. Period 2: Danicopan as the PIC 1 formulation under fed conditions. Period 3: Danicopan as the PIC 1 formulation under fasted conditions. There will be a washout period of at least 5 days between each danicopan dosing. |
Danicopan (200 milligrams) will be administered orally on Day 1.
Other Names:
Danicopan (200 milligrams) will be administered orally on Day 1.
Other Names:
|
Experimental: Part 2: Sequence 1
Participants will receive danicopan once each period as a single oral dose under fasted or fed conditions as follows: Period 1: Danicopan as the PIC 2 formulation under fed conditions. Period 2: Danicopan as the PIC 2 formulation under fasted conditions. Period 3: Danicopan as a tablet under fed conditions. There will be a washout period of at least 5 days between each danicopan dosing. |
Danicopan (200 milligrams) will be administered orally on Day 1.
Other Names:
Danicopan (200 milligrams) will be administered orally on Day 1.
Other Names:
|
Experimental: Part 2: Sequence 2
Participants will receive danicopan once each period as a single oral dose under fasted or fed conditions as follows: Period 1: Danicopan as the PIC 2 formulation under fasted conditions. Period 2: Danicopan as a tablet under fed conditions. Period 3: Danicopan as the PIC 2 formulation under fed conditions. There will be a washout period of at least 5 days between each danicopan dosing. |
Danicopan (200 milligrams) will be administered orally on Day 1.
Other Names:
Danicopan (200 milligrams) will be administered orally on Day 1.
Other Names:
|
Experimental: Part 2: Sequence 3
Participants will receive danicopan once each period as a single oral dose under fasted or fed conditions as follows: Period 1: Danicopan as a tablet under fed conditions. Period 2: Danicopan as the PIC 2 formulation under fed conditions. Period 3: Danicopan as the PIC 2 formulation under fasted conditions. There will be a washout period of at least 5 days between each danicopan dosing. |
Danicopan (200 milligrams) will be administered orally on Day 1.
Other Names:
Danicopan (200 milligrams) will be administered orally on Day 1.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Relative Bioavailability Of Danicopan Prototype PIC 1 Formulation And Tablet Formulation
Time Frame: Up to 72 hours postdose
|
The relative bioavailability of the PIC 1 formulation versus the tablet formulation will be measured by the ratio of select pharmacokinetic (PK) parameters: maximum observed plasma concentration (Cmax), area under the concentration-time curve from time of administration to the last measurable concentration (AUC0-t), and area under the concentration-time curve from time 0 extrapolated to infinity (AUC0-inf).
|
Up to 72 hours postdose
|
AUC0-inf Of Danicopan Prototype PIC 1 Formulation Under Both Fed And Fasted Conditions
Time Frame: Up to 72 hours postdose
|
Up to 72 hours postdose
|
|
AUC0-t Of Danicopan Prototype PIC 1 Formulation Under Both Fed And Fasted Conditions
Time Frame: Up to 72 hours postdose
|
Up to 72 hours postdose
|
|
Cmax Of Danicopan Prototype PIC 1 Formulation Under Both Fed And Fasted Conditions
Time Frame: Up to 72 hours postdose
|
Up to 72 hours postdose
|
|
Time to maximum observed plasma concentration (Tmax) Of Danicopan Prototype PIC 1 Formulation Under Both Fed And Fasted Conditions
Time Frame: Up to 72 hours postdose
|
Up to 72 hours postdose
|
|
Relative Bioavailability Of Danicopan Prototype PIC 2 Formulation And Tablet Formulation
Time Frame: Up to 72 hours postdose
|
The relative bioavailability of the PIC 2 formulation versus the tablet formulation will be measured by the ratio of select PK parameters: Cmax, AUC0-t, and AUC0-inf.
|
Up to 72 hours postdose
|
AUC0-inf Of Danicopan Prototype PIC 2 Formulation Under Both Fed And Fasted Conditions
Time Frame: Up to 72 hours postdose
|
Up to 72 hours postdose
|
|
AUC0-t Of Danicopan Prototype PIC 2 Formulation Under Both Fed And Fasted Conditions
Time Frame: Up to 72 hours postdose
|
Up to 72 hours postdose
|
|
Cmax Of Danicopan Prototype PIC 2 Formulation Under Both Fed And Fasted Conditions
Time Frame: Up to 72 hours postdose
|
Up to 72 hours postdose
|
|
Tmax Of Danicopan Prototype PIC 2 Formulation Under Both Fed And Fasted Conditions
Time Frame: Up to 72 hours postdose
|
Up to 72 hours postdose
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number Of Participants Receiving Prototype PIC 1 And Tablet With Treatment-emergent Adverse Events Under Fed Conditions
Time Frame: Day 1 (postdose) through follow-up (10 [+/- 2] days dosing on Day 1)
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Day 1 (postdose) through follow-up (10 [+/- 2] days dosing on Day 1)
|
Number Of Participants Receiving Prototype PIC 1 With Treatment-emergent Adverse Events Under Fasted Conditions
Time Frame: Day 1 (postdose) through follow-up (10 [+/- 2] days dosing on Day 1)
|
Day 1 (postdose) through follow-up (10 [+/- 2] days dosing on Day 1)
|
Number Of Participants Receiving Prototype PIC 2 And Tablet With Treatment-emergent Adverse Events Under Fed Conditions
Time Frame: Day 1 (postdose) through follow-up (10 [+/- 2] days dosing on Day 1)
|
Day 1 (postdose) through follow-up (10 [+/- 2] days dosing on Day 1)
|
Number Of Participants Receiving Prototype PIC 2 With Treatment-emergent Adverse Events Under Fasted Conditions
Time Frame: Day 1 (postdose) through follow-up (10 [+/- 2] days dosing on Day 1)
|
Day 1 (postdose) through follow-up (10 [+/- 2] days dosing on Day 1)
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- ALXN2040-HV-119
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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