Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2026-01-11 @ 6:49 AM
Study NCT ID:
NCT03276858
Status:
COMPLETED
Last Update Posted:
2018-08-29
First Post:
2017-09-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single and Multiple-Ascending Dose Study of CRN00808 in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008874', 'term': 'Midazolam'}], 'ancestors': [{'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, '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. The midazolam cohort does not have placebo.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 99}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2018-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-27', 'studyFirstSubmitDate': '2017-09-05', 'studyFirstSubmitQcDate': '2017-09-07', 'lastUpdatePostDateStruct': {'date': '2018-08-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of CRN00808 single ascending doses using clinical assessments, telemetry, and Holter monitoring and subject self-reporting', 'timeFrame': 'Day 1 through Day 10', 'description': 'ECG, clinical laboratory parameters, vital signs, physical examinations, telemetry, Holter monitoring'}, {'measure': 'Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of CRN00808 multiple ascending doses using clinical assessments and subject self-reporting', 'timeFrame': 'Day 1 through Day 21', 'description': 'ECG, clinical laboratory parameters, vital signs, physical examinations'}], 'secondaryOutcomes': [{'measure': 'AUC of CRN00808 single ascending doses', 'timeFrame': 'Day 1 through Day 7', 'description': 'plasma AUC'}, {'measure': 'Cmax of CRN00808 single ascending doses', 'timeFrame': 'Day 1 through Day 7', 'description': 'plasma Cmax'}, {'measure': 't1/2 of CRN00808 single ascending doses', 'timeFrame': 'Day 1 through Day 7', 'description': 'plasma t1/2'}, {'measure': 'Tmax of CRN00808 single ascending doses', 'timeFrame': 'Day 1 through Day 7', 'description': 'plasma Tmax'}, {'measure': 'AUC of CRN00808 multiple ascending doses', 'timeFrame': 'Day 1 through Day 20', 'description': 'plasma AUC'}, {'measure': 'Cmax of CRN00808 multiple ascending doses', 'timeFrame': 'Day 1 through Day 20', 'description': 'plasma Cmax'}, {'measure': 't1/2 of CRN00808 multiple ascending doses', 'timeFrame': 'Day 1 through Day 20', 'description': 'plasma t1/2'}, {'measure': 'Tmax of CRN00808 multiple ascending doses', 'timeFrame': 'Day 1 through Day 20', 'description': 'plasma Tmax'}, {'measure': 'Pharmacodynamics of CRN00808 in single ascending dose cohorts assessed by GHRH analog stimulated GH levels', 'timeFrame': 'Day -1 and Day 1', 'description': 'Suppression of serum GH induced by a GH secretagogue'}, {'measure': 'Effect of CRN00808 on pharmacokinetics of midazolam', 'timeFrame': 'Day 1 through Day 10', 'description': 'midazolam plasma AUC'}, {'measure': 'Effect of CRN00808 on Cmax of midazolam', 'timeFrame': 'Day 1 through Day 10', 'description': 'midazolam plasma Cmax'}, {'measure': 'Effect of CRN00808 on t1/2 of midazolam', 'timeFrame': 'Day 1 through Day 10', 'description': 'midazolam plasma t 1/2'}, {'measure': 'Effect of CRN00808 on Tmax of midazolam', 'timeFrame': 'Day 1 through Day 10', 'description': 'midazolam plasma Tmax'}, {'measure': 'Relative bioavailability of capsule formulation', 'timeFrame': 'Day 1 to Day 7', 'description': 'single-dose crossover arm only'}, {'measure': 'Effect of food on Cmax of CRN00808', 'timeFrame': 'Day 1 to Day 7', 'description': 'plasma Cmax compared with and without food in single dose arm'}, {'measure': 'Effect of food on AUC of CRN00808', 'timeFrame': 'Day 1 to Day 7', 'description': 'Plasma AUC compared with and without food in single dose arm'}, {'measure': 'Pharmacodynamics of CRN00808 in multiple ascending dose cohorts assessed by serum IGF-1 and GH', 'timeFrame': 'Day -1 to Day 21', 'description': 'serum IGF-1 and GH'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'referencesModule': {'references': [{'pmid': '35000098', 'type': 'DERIVED', 'citation': 'Madan A, Markison S, Betz SF, Krasner A, Luo R, Jochelson T, Lickliter J, Struthers RS. Paltusotine, a novel oral once-daily nonpeptide SST2 receptor agonist, suppresses GH and IGF-1 in healthy volunteers. Pituitary. 2022 Apr;25(2):328-339. doi: 10.1007/s11102-021-01201-z. Epub 2022 Jan 9.'}]}, 'descriptionModule': {'briefSummary': 'This single-center study will be conducted in 3 phases: a single-ascending dose phase (up to 8 cohorts, 8 subjects/cohort), a multiple-dose phase (up to 5 cohorts, 9 subjects/cohort), and a midazolam drug-drug interaction phase (one cohort of 8 subjects).', 'detailedDescription': 'The single-dose phase initiates with ascending doses of an oral solution followed by a 3-way crossover food effect and bioavailability (capsule formulation) cohort. Serum IGF-1 levels and GHRH-analog stimulated GH levels will be assessed as pharmacodynamics measures.\n\nThe first multiple-dose (7 days dosing) cohort will be initiated after the PK and safety data are available from the single-dose phase. Subsequent multiple-dose cohorts will have 10 days of dosing. Serum IGF-1 level and GH levels will be assessed as pharmacodynamics measures.\n\nThe last cohort in the study is midazolam drug-drug interaction study. The dose will be selected based on review of all pharmacokinetic and safety data for the single-dose and multiple-dose cohorts completed. On Day 1, 8 subjects will receive a single oral 2 mg dose of midazolam. Starting on Day 3 through Day 8, subjects will receive daily doses of CRN00808. On Day 9, subjects will be administered CRN00808 and 2 mg midazolam together.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* BMI 18 to 30 kg/m2\n* Females postmenopausal or surgically sterile\n\nExclusion Criteria:\n\n* Any uncontrolled or active major systemic disease including, but not limited to: acromegaly (with or without pituitary surgery or radiation therapy), cardiac, pulmonary, gastrointestinal, metabolic, urogenital, neurological, immunological, psychiatric, or neoplastic disorder with metastatic potential\n* History or presence of malignancy within the past 5 years. Subjects who have been successfully treated (for 3 months or longer) with no recurrence of basal or squamous cell carcinoma of the skin or carcinoma in-situ of the cervix may be enrolled.\n* Use of any investigational drug within the past 60 days or 5 half-lives, whichever is longer\n* Have a medically significant abnormality observed during screening or the admission physical examination or in any other baseline measurements\n* Use of any prior medication without approval of the investigator within 14 days prior to admission\n* Tested positive at screening for HIV, hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCV-Ab) or has a history of a positive result\n* History of alcohol or substance abuse in the past 6 months\n* Any condition that in the opinion of the investigator would jeopardize the subject's appropriate participation in this Phase 1 study"}, 'identificationModule': {'nctId': 'NCT03276858', 'briefTitle': 'Single and Multiple-Ascending Dose Study of CRN00808 in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Crinetics Pharmaceuticals Inc.'}, 'officialTitle': 'A Double-Blind, Randomized, Placebo-Controlled, Single- And-Multiple-Dose Study to Evaluate the Safety, PK, and PD of CRN00808 in Healthy Volunteers and to Determine the Effect of CRN00808 on Midazolam PK', 'orgStudyIdInfo': {'id': 'CRN00808-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CRN00808 Oral Solution', 'description': 'CRN00808 oral solution, single-dose', 'interventionNames': ['Drug: CRN00808']}, {'type': 'EXPERIMENTAL', 'label': 'CRN00808 Oral Capsule', 'description': 'CRN00808 oral capsule, single-dose and multiple-doses', 'interventionNames': ['Drug: CRN00808']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Oral Solution', 'description': 'Placebo oral solution, single-dose', 'interventionNames': ['Drug: Placebo Oral Solution']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Oral Capsule', 'description': 'Placebo oral capsule, single-dose and multiple doses', 'interventionNames': ['Drug: Placebo oral capsule']}, {'type': 'OTHER', 'label': 'Midazolam Oral Solution', 'description': 'Midazolam oral solution, two single-doses as part of the drug-drug interaction arm of the study', 'interventionNames': ['Drug: CRN00808', 'Drug: Midazolam oral solution']}], 'interventions': [{'name': 'CRN00808', 'type': 'DRUG', 'description': 'Investigational drug', 'armGroupLabels': ['CRN00808 Oral Capsule', 'CRN00808 Oral Solution', 'Midazolam Oral Solution']}, {'name': 'Placebo Oral Solution', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Placebo Oral Solution']}, {'name': 'Midazolam oral solution', 'type': 'DRUG', 'description': 'Midazolam as part of the drug-drug interaction arm of the study', 'armGroupLabels': ['Midazolam Oral Solution']}, {'name': 'Placebo oral capsule', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Placebo Oral Capsule']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Nucleus Network', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}], 'overallOfficials': [{'name': 'Jason Lickliter, MBBS PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nucleus Network'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Crinetics Pharmaceuticals Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}