Study of Different Forms of Danicopan (Tablet, Softgel Capsule, Liquid-filled Capsule) in Healthy Participants
NCT ID: NCT04940559
Last Updated: 2021-06-25
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
26 participants
INTERVENTIONAL
2016-08-02
2016-10-05
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of the Metabolism of Danicopan in Healthy Adults
NCT04609696
Study of Danicopan in Participants of Japanese Descent
NCT04451434
A Study of Modified Release Formulations of Danicopan in Healthy Adult Participants
NCT03384186
A Study of the Effects of Food and Age on Danicopan
NCT04551599
A Study to Assess ACH-0145228 When Administered as Immediate Release Tablet Versus Powder-In-Capsule in Healthy Adult Participants
NCT04551586
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group 1: Sequence 1
Participants received danicopan once each period as a single dose under fasted or fed (medium-fat meal) conditions as follows:
Period 1: Danicopan as an LFC under fasted conditions. Period 2: Danicopan as a tablet under fed (medium-fat meal) conditions. Period 3: Danicopan as a tablet under fasted conditions. There was a washout period of at least 4 days (96 hours) between each danicopan dosing.
Danicopan - Tablet
Oral tablet.
Danicopan - LFC
Oral LFC.
Group 1: Sequence 2
Participants received danicopan once each period as a single dose under fasted or fed (medium-fat meal) conditions as follows:
Period 1: Danicopan as a tablet under fed (medium-fat meal) conditions. Period 2: Danicopan as a tablet under fasted conditions. Period 3: Danicopan as an LFC under fasted conditions. There was a washout period of at least 4 days (96 hours) between each danicopan dosing.
Danicopan - Tablet
Oral tablet.
Danicopan - LFC
Oral LFC.
Group 1: Sequence 3
Participants received danicopan once each period as a single dose under fasted or fed (medium-fat meal) conditions as follows:
Period 1: Danicopan as a tablet under fasted conditions. Period 2: Danicopan as an LFC under fasted conditions. Period 3: Danicopan as a tablet under fed (medium-fat meal) conditions. There was a washout period of at least 4 days (96 hours) between each danicopan dosing.
Danicopan - Tablet
Oral tablet.
Danicopan - LFC
Oral LFC.
Group 2: Sequence 1
Participants received danicopan once each period as a single dose under fasted conditions as follows:
Period 1: Danicopan as an LFC under fasted conditions. Period 2: Danicopan as a softgel capsule under fasted conditions. There was a washout period of at least 4 days (96 hours) between each danicopan dosing.
Danicopan - Softgel
Oral softgel capsule.
Danicopan - LFC
Oral LFC.
Group 2: Sequence 2
Participants received danicopan once each period as a single dose under fasted conditions as follows:
Period 1: Danicopan as a softgel capsule under fasted conditions. Period 2: Danicopan as an LFC under fasted conditions. There was a washout period of at least 4 days (96 hours) between each danicopan dosing.
Danicopan - Softgel
Oral softgel capsule.
Danicopan - LFC
Oral LFC.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Danicopan - Tablet
Oral tablet.
Danicopan - Softgel
Oral softgel capsule.
Danicopan - LFC
Oral LFC.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Had a body mass index of 18 to 30 kilograms(kg)/meter squared with a minimum body weight of 50 kg.
Exclusion Criteria
* 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.
18 Years
55 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Achillion, a wholly owned subsidiary of Alexion
INDUSTRY
Alexion Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Clinical Trial Site
Auckland, , New Zealand
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ACTRN12616001017415
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACH471-006
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.