Study of Different Forms of Danicopan (Tablet, Softgel Capsule, Liquid-filled Capsule) in Healthy Participants
NCT04940559 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26
Last updated 2021-06-25
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.
Conditions
- Healthy
Interventions
- DRUG
-
Danicopan - Tablet
Oral tablet.
- DRUG
-
Danicopan - Softgel
Oral softgel capsule.
- DRUG
-
Danicopan - LFC
Oral LFC.
Sponsors & Collaborators
-
Achillion, a wholly owned subsidiary of Alexion
collaborator INDUSTRY -
Alexion Pharmaceuticals, Inc.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2016-08-02
- Primary Completion
- 2016-10-05
- Completion
- 2016-10-05
Countries
- New Zealand
Study Locations
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