Ignite Creation Date:
2025-12-24 @ 4:27 PM
Ignite Modification Date:
2026-01-04 @ 8:33 AM
Study NCT ID:
NCT03936166
Status:
COMPLETED
Last Update Posted:
2020-11-04
First Post:
2019-04-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Single and Multiple-Ascending Dose Study of CRN01941 in Healthy Adult Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Double-blind study'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Single and multiple-dose cohorts are placebo-controlled.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 57}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2019-12-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-02', 'studyFirstSubmitDate': '2019-04-25', 'studyFirstSubmitQcDate': '2019-05-02', 'lastUpdatePostDateStruct': {'date': '2020-11-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with treatment emergent adverse events by severity', 'timeFrame': 'Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8'}, {'measure': 'Number of participants with serious adverse events (SAEs)', 'timeFrame': 'Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8'}, {'measure': 'Number of participants with clinically significant changes in vital signs', 'timeFrame': 'Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8'}, {'measure': 'Number of participants with ECG abnormalities', 'timeFrame': 'Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8'}, {'measure': 'Number of participants with clinical laboratory abnormalities', 'timeFrame': 'Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics (AUC)', 'timeFrame': 'Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8', 'description': 'Assessment of the plasma area under the curve of CRN01941'}, {'measure': 'Pharmacokinetics (Cmax)', 'timeFrame': 'Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8', 'description': 'Assessment of the maximum observed plasma concentration of CRN01941'}, {'measure': 'Pharmacokinetics (Tmax)', 'timeFrame': 'Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8', 'description': 'Assessment of the time to reach Cmax for CRN01941'}, {'measure': 'Pharmacokinetics (T1/2)', 'timeFrame': 'Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8', 'description': 'Assessment of the elimination half-life of CRN01941'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'This is a Phase 1, double-blind, randomized, placebo-controlled, single-dose and multiple-dose study of CRN01941 in up to 119 healthy male and female subjects. This single-center study will be conducted in 3 parts: a single-ascending dose phase (up to 8 cohorts, 8 subjects/cohort), a multiple-ascending dose phase (up to 5 cohorts, 9 subjects/cohort), and single dose phase in elderly subjects (1 cohort, 10 subjects).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Male and female subjects 18 to 55 years of age, inclusive, at time of screening (Parts 1 and 2 only).\n2. Males and females subjects 65 to 85 years of age at screening (Part 3 only).\n3. Females must be non-pregnant and non-lactating, postmenopausal by history and confirmed by follicle stimulating hormone (FSH) \\>30 U/L at Screening, or surgically sterile.\n4. Male subjects must be surgically sterile or agree to use highly effective form of contraception when sexually active with a female partner of child bearing potential.\n5. Body mass index (BMI) of 18 to 32 kg/m2, inclusive at Screening.\n6. Willing to provide signed informed consent.\n\nExclusion Criteria:\n\n1. Any uncontrolled or active major systemic disease which makes study participation unsafe or could interfere with evaluation of the endpoints of the study.\n2. History or presence of malignancy within the past 5 years, not including treated basal cell carcinomas and in situ cervical neoplasia.\n3. Use of any investigational drug within the past 60 days.\n4. Have a medically significant abnormality observed during screening or admission.\n5. Use of any prior medication without approval of the investigator within 14 days prior to admission.\n6. Subjects with human immunodeficiency virus (HIV), hepatitis B or hepatitis C infections. Subjects with previous hepatitis C infection that is now cured may be eligible.\n7. History of or current alcohol or substance abuse in the past 12 months\n8. Any condition that in the opinion of the investigator would jeopardize the subject's appropriate participation in this Phase 1 study."}, 'identificationModule': {'nctId': 'NCT03936166', 'briefTitle': 'A Single and Multiple-Ascending Dose Study of CRN01941 in Healthy Adult Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Crinetics Pharmaceuticals Inc.'}, 'officialTitle': 'A Double-Blind, Randomized, Placebo-Controlled, Single- And-Multiple-Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of CRN01941 in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'CRN01941-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single Ascending Dose (Part 1)', 'interventionNames': ['Drug: CRN01941 Oral Solution', 'Drug: CRN01941 Oral Capsule', 'Drug: Placebo Oral Solution', 'Drug: Placebo Oral Capsule']}, {'type': 'EXPERIMENTAL', 'label': 'Multiple Ascending Dose (Part 2)', 'interventionNames': ['Drug: CRN01941 Oral Solution', 'Drug: CRN01941 Oral Capsule', 'Drug: Placebo Oral Solution', 'Drug: Placebo Oral Capsule']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Elderly Cohort (Part 3)', 'interventionNames': ['Drug: CRN01941 Oral Solution', 'Drug: CRN01941 Oral Capsule', 'Drug: Placebo Oral Solution', 'Drug: Placebo Oral Capsule']}], 'interventions': [{'name': 'CRN01941 Oral Solution', 'type': 'DRUG', 'description': 'Investigational drug', 'armGroupLabels': ['Elderly Cohort (Part 3)', 'Multiple Ascending Dose (Part 2)', 'Single Ascending Dose (Part 1)']}, {'name': 'CRN01941 Oral Capsule', 'type': 'DRUG', 'description': 'Investigational drug', 'armGroupLabels': ['Elderly Cohort (Part 3)', 'Multiple Ascending Dose (Part 2)', 'Single Ascending Dose (Part 1)']}, {'name': 'Placebo Oral Solution', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Elderly Cohort (Part 3)', 'Multiple Ascending Dose (Part 2)', 'Single Ascending Dose (Part 1)']}, {'name': 'Placebo Oral Capsule', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Elderly Cohort (Part 3)', 'Multiple Ascending Dose (Part 2)', 'Single Ascending Dose (Part 1)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6009', 'city': 'Perth', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'Linear Clinical Research', 'geoPoint': {'lat': -31.95224, 'lon': 115.8614}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Crinetics Pharmaceuticals Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}