Study of the Metabolism of Danicopan in Healthy Adults

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04609696
• Other study ID #: ALXN2040-HV-119
• Status: Completed
• Phase: Phase 1
• Start date: October 20, 2020
• Est. completion date: December 7, 2020

Study information

• Verified date: April 2022
• Source: Alexion Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 7, 2020
• Est. primary completion date: December 7, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Danicopan: Powder-In-Capsule 1
Danicopan (200 milligrams) will be administered orally on Day 1.
• Danicopan: Powder-In-Capsule 2
Danicopan (200 milligrams) will be administered orally on Day 1.
• Danicopan: Tablet
Danicopan (200 milligrams) will be administered orally on Day 1.

Locations

Country	Name	City	State
United States	Clinical Trial Site	Tempe	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Alexion Pharmaceuticals	Celerion

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relative Bioavailability Of Danicopan Prototype PIC 1 Formulation And Tablet Formulation	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
Primary	AUC0-inf Of Danicopan Prototype PIC 1 Formulation Under Both Fed And Fasted Conditions		Up to 72 hours postdose
Primary	AUC0-t Of Danicopan Prototype PIC 1 Formulation Under Both Fed And Fasted Conditions		Up to 72 hours postdose
Primary	Cmax Of Danicopan Prototype PIC 1 Formulation Under Both Fed And Fasted Conditions		Up to 72 hours postdose
Primary	Time to maximum observed plasma concentration (Tmax) Of Danicopan Prototype PIC 1 Formulation Under Both Fed And Fasted Conditions		Up to 72 hours postdose
Primary	Relative Bioavailability Of Danicopan Prototype PIC 2 Formulation And Tablet Formulation	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
Primary	AUC0-inf Of Danicopan Prototype PIC 2 Formulation Under Both Fed And Fasted Conditions		Up to 72 hours postdose
Primary	AUC0-t Of Danicopan Prototype PIC 2 Formulation Under Both Fed And Fasted Conditions		Up to 72 hours postdose
Primary	Cmax Of Danicopan Prototype PIC 2 Formulation Under Both Fed And Fasted Conditions		Up to 72 hours postdose
Primary	Tmax Of Danicopan Prototype PIC 2 Formulation Under Both Fed And Fasted Conditions		Up to 72 hours postdose
Secondary	Number Of Participants Receiving Prototype PIC 1 And Tablet With Treatment-emergent Adverse Events Under Fed Conditions		Day 1 (postdose) through follow-up (10 [+/- 2] days dosing on Day 1)
Secondary	Number Of Participants Receiving Prototype PIC 1 With Treatment-emergent Adverse Events Under Fasted Conditions		Day 1 (postdose) through follow-up (10 [+/- 2] days dosing on Day 1)
Secondary	Number Of Participants Receiving Prototype PIC 2 And Tablet With Treatment-emergent Adverse Events Under Fed Conditions		Day 1 (postdose) through follow-up (10 [+/- 2] days dosing on Day 1)
Secondary	Number Of Participants Receiving Prototype PIC 2 With Treatment-emergent Adverse Events Under Fasted Conditions		Day 1 (postdose) through follow-up (10 [+/- 2] days dosing on Day 1)