Ignite Creation Date:
2025-12-24 @ 3:03 PM
Ignite Modification Date:
2026-03-08 @ 11:03 PM
Study NCT ID:
NCT04940559
Status:
COMPLETED
Last Update Posted:
2021-06-25
First Post:
2021-06-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Different Forms of Danicopan (Tablet, Softgel Capsule, Liquid-filled Capsule) in Healthy Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000718467', 'term': 'danicopan'}, {'id': 'D020742', 'term': 'rhoA GTP-Binding Protein'}], 'ancestors': [{'id': 'D020741', 'term': 'rho GTP-Binding Proteins'}, {'id': 'D020559', 'term': 'Monomeric GTP-Binding Proteins'}, {'id': 'D019204', 'term': 'GTP-Binding Proteins'}, {'id': 'D020558', 'term': 'GTP Phosphohydrolases'}, {'id': 'D017766', 'term': 'Acid Anhydride Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D002352', 'term': 'Carrier Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D047908', 'term': 'Intracellular Signaling Peptides and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Group 1 followed a 3-treatment, 3-period crossover study design. Group 2 followed a 2-treatment, 2-period crossover study design.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2016-10-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-21', 'studyFirstSubmitDate': '2021-06-21', 'studyFirstSubmitQcDate': '2021-06-21', 'lastUpdatePostDateStruct': {'date': '2021-06-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-10-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PK: Maximum Plasma Concentration (Cmax) Of Danicopan After Treatment With Each Of The Three Formulations', 'timeFrame': 'Up to 96 hours postdose'}, {'measure': 'PK: Time To Reach The Maximum Plasma Concentration (Tmax) Of Danicopan After Treatment With Each Of The Three Formulations', 'timeFrame': 'Up to 96 hours postdose'}, {'measure': 'PK: Area Under The Plasma Concentration-time Curve Extrapolated To Infinity (AUC0-Inf) Of Danicopan After Treatment With Each Of The Three Formulations', 'timeFrame': 'Up to 96 hours postdose'}], 'secondaryOutcomes': [{'measure': 'PK: Cmax Of Danicopan After Treatment With The Tablet Under Fed And Fasted Conditions', 'timeFrame': 'Up to 96 hours postdose'}, {'measure': 'PK: Tmax Of Danicopan After Treatment With The Tablet Under Fed And Fasted Conditions', 'timeFrame': 'Up to 96 hours postdose'}, {'measure': 'PK: AUC0-inf Of Danicopan After Treatment With The Tablet Under Fed And Fasted Conditions', 'timeFrame': 'Up to 96 hours postdose'}, {'measure': 'Incidence Of Serious Adverse Events, Grade 3 Or 4 Adverse Events (AEs), And AEs Leading To Discontinuation', 'timeFrame': 'Day 1 through Day 39'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Danicopan', 'ALXN2040', 'ACH-0144471', 'Relative Bioavailability', 'LFC', 'Tablet', 'Softgel Capsule', 'Food Effect', 'Pharmacokinetics', 'Factor D Inhibitor', 'Safety'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* 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.\n* Had a body mass index of 18 to 30 kilograms(kg)/meter squared with a minimum body weight of 50 kg.\n\nKey Exclusion Criteria:\n\n* History or clinically relevant evidence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease.\n* History of procedures that could alter absorption of orally administered drugs.\n* Body temperature ≥ 38°Celsius on Day -1 or Day 1 predose; history of febrile illness within 7 days prior to study drug administration.\n* Positive alcohol and/or drug screen at Screening or Day -1; current tobacco/nicotine user.\n* Participation in a clinical study within 30 days prior to study drug administration.\n* Clinically significant laboratory abnormalities at Screening or Day -1.'}, 'identificationModule': {'nctId': 'NCT04940559', 'briefTitle': 'Study of Different Forms of Danicopan (Tablet, Softgel Capsule, Liquid-filled Capsule) in Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alexion Pharmaceuticals, Inc.'}, 'officialTitle': 'A Phase 1 Study To Determine The Relative Bioavailability Of ACH-0144471 After Administration Of A Tablet Or Softgel Capsule Versus A Liquid Filled Capsule In Healthy Volunteers', 'orgStudyIdInfo': {'id': 'ACH471-006'}, 'secondaryIdInfos': [{'id': 'ACTRN12616001017415', 'type': 'REGISTRY', 'domain': 'ANZCTR'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1: Sequence 1', 'description': 'Participants received danicopan once each period as a single dose under fasted or fed (medium-fat meal) conditions as follows:\n\nPeriod 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.', 'interventionNames': ['Drug: Danicopan - Tablet', 'Drug: Danicopan - LFC']}, {'type': 'EXPERIMENTAL', 'label': 'Group 1: Sequence 2', 'description': 'Participants received danicopan once each period as a single dose under fasted or fed (medium-fat meal) conditions as follows:\n\nPeriod 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.', 'interventionNames': ['Drug: Danicopan - Tablet', 'Drug: Danicopan - LFC']}, {'type': 'EXPERIMENTAL', 'label': 'Group 1: Sequence 3', 'description': 'Participants received danicopan once each period as a single dose under fasted or fed (medium-fat meal) conditions as follows:\n\nPeriod 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.', 'interventionNames': ['Drug: Danicopan - Tablet', 'Drug: Danicopan - LFC']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2: Sequence 1', 'description': 'Participants received danicopan once each period as a single dose under fasted conditions as follows:\n\nPeriod 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.', 'interventionNames': ['Drug: Danicopan - Softgel', 'Drug: Danicopan - LFC']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2: Sequence 2', 'description': 'Participants received danicopan once each period as a single dose under fasted conditions as follows:\n\nPeriod 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.', 'interventionNames': ['Drug: Danicopan - Softgel', 'Drug: Danicopan - LFC']}], 'interventions': [{'name': 'Danicopan - Tablet', 'type': 'DRUG', 'otherNames': ['ALXN2040', 'ACH-0144471 (formerly)', 'ACH-4471', 'ACH4471', '4471'], 'description': 'Oral tablet.', 'armGroupLabels': ['Group 1: Sequence 1', 'Group 1: Sequence 2', 'Group 1: Sequence 3']}, {'name': 'Danicopan - Softgel', 'type': 'DRUG', 'otherNames': ['ALXN2040', 'ACH-0144471 (formerly)', 'ACH-4471', 'ACH4471', '4471'], 'description': 'Oral softgel capsule.', 'armGroupLabels': ['Group 2: Sequence 1', 'Group 2: Sequence 2']}, {'name': 'Danicopan - LFC', 'type': 'DRUG', 'otherNames': ['ALXN2040', 'ACH-0144471 (formerly)', 'ACH-4471', 'ACH4471', '4471'], 'description': 'Oral LFC.', 'armGroupLabels': ['Group 1: Sequence 1', 'Group 1: Sequence 2', 'Group 1: Sequence 3', 'Group 2: Sequence 1', 'Group 2: Sequence 2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Auckland', 'country': 'New Zealand', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': -36.84853, 'lon': 174.76349}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alexion Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Achillion, a wholly owned subsidiary of Alexion', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}