Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-29 @ 1:32 PM
Study NCT ID:
NCT04551534
Status:
COMPLETED
Last Update Posted:
2020-09-16
First Post:
2020-09-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL201 in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C587728', 'term': '2-methyl-2-(3-methyl-4-((4-(methylamino)-5-(trifluoromethyl)pyrimidin-2-yl)amino)-1H-pyrazol-1-yl)propanenitrile'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 122}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2018-08-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-10', 'studyFirstSubmitDate': '2020-09-10', 'studyFirstSubmitQcDate': '2020-09-10', 'lastUpdatePostDateStruct': {'date': '2020-09-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of treatment-emergent adverse events (TEAEs) including serious adverse events (SAEs), and discontinuations due to TEAEs', 'timeFrame': 'Up to 20 days'}, {'measure': 'PK parameter: Maximum observed concentration (Cmax) of DNL201 in plasma', 'timeFrame': 'Up to 10 days'}, {'measure': 'PK parameter: Time to maximum observed concentration (Tmax) of DNL201 in plasma', 'timeFrame': 'Up to 10 days'}, {'measure': 'PK parameter: The area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞) of DNL201 in plasma (single dosing only)', 'timeFrame': 'Up to 10 days'}, {'measure': 'PK parameter: Area under the concentration-time curve from time zero to the time of last quantifiable concentration (AUC[0-last]) of DNL201 in plasma', 'timeFrame': 'Up to 10 days'}, {'measure': 'PK parameter: The area under the concentration-time curve over a dosing interval (AUC0-τ) of DNL201 in plasma (multiple dosing only)', 'timeFrame': 'Up to 10 days'}, {'measure': 'PK parameter: Apparent terminal elimination half-life (t1/2) of DNL201 in plasma', 'timeFrame': 'Up to 10 days'}], 'secondaryOutcomes': [{'measure': 'Concentration of DNL201 in cerebrospinal fluid (CSF) (following selected single and multiple doses)', 'timeFrame': 'Up to 10 days'}, {'measure': 'The pharmacodynamics of DNL201 in whole blood as measured by the percent change from baseline in pS935', 'timeFrame': 'Up to 10 days'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'referencesModule': {'references': [{'pmid': '40680102', 'type': 'DERIVED', 'citation': "Joshi D, Kulkarni M, Parekh P, Shah S, Greig NH, Acharya S. Targeting protein kinases in Parkinson's disease: the emerging role of phytoconstituents. Nutr Neurosci. 2025 Dec;28(12):1532-1563. doi: 10.1080/1028415X.2025.2531356. Epub 2025 Jul 18."}]}, 'descriptionModule': {'briefSummary': 'This is a Phase 1, randomized, double-blind, placebo-controlled, single- and multiple-ascending oral dose study conducted in three parts.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Body mass index 18.5 to 35.0 kg/m², inclusive, and body weight of at least 50.0 kg at screening\n* In good health, determined by no clinically significant findings from medical history, physical examination, and vital sign measurements\n* Women of non-childbearing potential and men using contraceptive measures\n\nKey Exclusion Criteria:\n\n* History of clinically significant hematological, renal, pancreatic, gastrointestinal, hepatic, cardiovascular, metabolic, endocrine, immunological, allergic disease, or other major disorders\n* History of asthma, chronic obstructive pulmonary disease, or emphysema\n* Clinically significant neurologic disorder\n* History of stomach or intestinal surgery or resection\n* History of malignancy'}, 'identificationModule': {'nctId': 'NCT04551534', 'briefTitle': 'A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL201 in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Denali Therapeutics Inc.'}, 'officialTitle': 'A First-In-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Oral Doses of DNL201 in Healthy Subjects', 'orgStudyIdInfo': {'id': 'DNLI-B-0001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DNL201', 'description': 'Part 1: Single-ascending dose cohorts; Part 2: Multiple-ascending dose cohorts (10 days); Part 3: Additional multiple-dose cohort (10 days)', 'interventionNames': ['Drug: DNL201']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Part 1: Single-ascending dose cohorts; Part 2: Multiple-ascending dose cohorts (10 days); Part 3: Additional multiple-dose cohort (10 days)', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'DNL201', 'type': 'DRUG', 'description': 'Oral dose(s)', 'armGroupLabels': ['DNL201']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Oral dose(s)', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05247', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Clinical Site(s)', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Danna Jennings, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Denali Therapeutics Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Denali Therapeutics Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}