A Study of Modified Release Formulations of Danicopan in Healthy Adult Participants
NCT ID: NCT03384186
Last Updated: 2021-08-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
14 participants
INTERVENTIONAL
2017-12-01
2018-03-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Danicopan Modified Release Prototype Tablets
Participants received danicopan once each period as a single oral dose as follows:
Period 1: Danicopan Modified Release Prototype 1 under fasted conditions. Period 2: Danicopan Modified Release Prototype 2 under fasted conditions. Period 3: Danicopan Modified Release Prototype 3 under fasted conditions. Period 4: Danicopan Modified Release Prototype 2 under fed conditions.
There was a washout period of at least 14 days between each danicopan dosing.
Danicopan Modified Release Prototype 1
Danicopan (400 milligrams \[mg\]) oral tablet.
Danicopan Modified Release Prototype 2
Danicopan (400 mg) oral tablet.
Danicopan Modified Release Prototype 3
Danicopan (800 mg) oral tablet.
Interventions
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Danicopan Modified Release Prototype 1
Danicopan (400 milligrams \[mg\]) oral tablet.
Danicopan Modified Release Prototype 2
Danicopan (400 mg) oral tablet.
Danicopan Modified Release Prototype 3
Danicopan (800 mg) oral tablet.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
18 Years
55 Years
ALL
Yes
Sponsors
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Achillion, a wholly owned subsidiary of Alexion
INDUSTRY
Alexion Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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Clinical Trial Site
Ruddington, Nottingham, United Kingdom
Countries
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Other Identifiers
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2017-003525-15
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ACH471-011
Identifier Type: -
Identifier Source: org_study_id
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