Status:
COMPLETED
A Study of Modified Release Formulations of Danicopan in Healthy Adult Participants
Lead Sponsor:
Alexion Pharmaceuticals, Inc.
Collaborating Sponsors:
Achillion, a wholly owned subsidiary of Alexion
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of this study was to evaluate and compare the plasma pharmacokinetic profiles of ACH-0144471 (danicopan) in healthy participants after administration of single oral doses of modified relea...
Eligibility Criteria
Inclusion
- Body mass index of 18.0 to 30.0 kilograms/square meter.
- Female participants of childbearing potential must either agree to abstinence or use of a highly effective method of contraception.
- Male participants must either agree to abstinence or use of a condom plus an effective method of contraception.
Exclusion
- Participants who have received any investigational medicinal product in a clinical research study within the previous 3 months.
- History of any drug or alcohol abuse in the past 2 years; current tobacco/nicotine user or within the last 12 months; positive drugs of abuse test result.
- Clinically significant laboratory abnormalities.
- History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder.
- History or family history of meningococcal infection.
- Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients.
- Presence or history of clinically significant allergy requiring treatment.
- Donation or loss of greater than 400 milliliters of blood within the previous 3 months.
- Note: Other inclusion/exclusion criteria may apply, per protocol.
Key Trial Info
Start Date :
December 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 21 2018
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT03384186
Start Date
December 1 2017
End Date
March 21 2018
Last Update
August 20 2021
Active Locations (1)
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1
Clinical Trial Site
Ruddington, Nottingham, United Kingdom, NG111 6JS