Study of Different Forms of Danicopan (Tablet, Softgel Capsule, Liquid-filled Capsule) in Healthy Participants
Study Identifier:
ACH471-006
ClinicalTrials.gov Identifier:
EudraCT Identifier:
N/A
EU CT ID:
N/A
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
N/A
Study Complete
Study Details
Medical Condition
- Other
Study Drug
- Drug: Danicopan - Tablet
- Drug: Danicopan - Softgel
- Drug: Danicopan - LFC
Date
Aug 2016 - Oct 2016
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 55 Years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
- Healthy was defined as having no clinically relevant abnormalities identified by a detailed medical history, physical examination, blood pressure and heart rate measurements, 12-lead electrocardiogram, and clinical laboratory tests.
- Had a body mass index of 18 to 30 kilograms(kg)/meter squared with a minimum body weight of 50 kg.
Exclusion Criteria
- History or clinically relevant evidence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease.
- History of procedures that could alter absorption of orally administered drugs.
- Body temperature ≥ 38°Celsius on Day -1 or Day 1 predose; history of febrile illness within 7 days prior to study drug administration.
- Positive alcohol and/or drug screen at Screening or Day -1; current tobacco/nicotine user.
- Participation in a clinical study within 30 days prior to study drug administration.
- Clinically significant laboratory abnormalities at Screening or Day -1.
Sex
Female & Male
Age
18 - 55 Years
Study Details
Medical Condition
- Other
Study Drug
- Drug: Danicopan - Tablet
- Drug: Danicopan - Softgel
- Drug: Danicopan - LFC
Date
Aug 2016 - Oct 2016
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 55 Years years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
- Healthy was defined as having no clinically relevant abnormalities identified by a detailed medical history, physical examination, blood pressure and heart rate measurements, 12-lead electrocardiogram, and clinical laboratory tests.
- Had a body mass index of 18 to 30 kilograms(kg)/meter squared with a minimum body weight of 50 kg.
Exclusion Criteria
- History or clinically relevant evidence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease.
- History of procedures that could alter absorption of orally administered drugs.
- Body temperature ≥ 38°Celsius on Day -1 or Day 1 predose; history of febrile illness within 7 days prior to study drug administration.
- Positive alcohol and/or drug screen at Screening or Day -1; current tobacco/nicotine user.
- Participation in a clinical study within 30 days prior to study drug administration.
- Clinically significant laboratory abnormalities at Screening or Day -1.
Protocol Summary
This was a randomized, crossover, open-label study to assess the relative bioavailability, pharmacokinetics (PK), and safety of three different formulations of danicopan (tablet, softgel capsule, liquid-filled capsule \[LFC\]) in healthy participants.
Trial Locations
Location
Status
Location
Clinical Trial Site
Auckland, New Zealand
Status
N/A