Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2026-02-25 @ 4:57 PM
Study NCT ID:
NCT02382666
Status:
COMPLETED
Last Update Posted:
2015-08-25
First Post:
2015-03-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 1, 2-Part, Single Ascending Dose Assessment of the Safety, Tolerability, and Pharmacokinetics of Rolapitant Intravenous in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014839', 'term': 'Vomiting'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C578834', 'term': 'rolapitant'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-21', 'studyFirstSubmitDate': '2015-03-03', 'studyFirstSubmitQcDate': '2015-03-06', 'lastUpdatePostDateStruct': {'date': '2015-08-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Part 1 Dose Escalation: Safety and Tolerability (adverse events)', 'timeFrame': '0-30 days after administration of study drug', 'description': 'To evaluate the safety and tolerability of rolapitant IV (30 minutes infusion) in healthy adult volunteers as assessed by the incidence and severity of AEs'}, {'measure': 'Part 2 Dose Treatment: Safety and Tolerability (adverse events)', 'timeFrame': ': 0-30 days after administration of study drug', 'description': 'To evaluate the safety and tolerability of rolapitant IV (30 minutes infusion) to an expanded cohort of healthy adult volunteers at the highest safe and well-tolerated dose established in Part 1 as assessed by the incidence and severity of AEs.'}], 'secondaryOutcomes': [{'measure': '1. AUC0-last: area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration', 'timeFrame': '0-21 days'}, {'measure': '2. Cmax = observed maximum plasma concentration', 'timeFrame': '0-21 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chemotherapy-induced Nausea and Vomiting']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the safety and tolerability of single increasing doses of intravenously administered rolapitant in healthy male and female subjects.', 'detailedDescription': 'Part 1 of the study is designed to evaluate the safety and tolerability of a SAD, up to 6 cohorts,of rolapitant IV (2 mg/mL solution) administered as an IV infusion over 30 minutes.\n\nIn Part 2 of the study, the safety and tolerability of the highest safe and well-tolerated dose established in Part 1 will be evaluated in an expanded cohort. The highest safe and well-tolerated dose established in Part 1 will be ascertained by the following criteria: an upper limit of 90% confidence interval (CI) for Cmax. A minimum of 40 subjects will be enrolled in Part 2.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Main Inclusion Criteria:\n\n* Subject must be a healthy male or female aged 18 to 55 years at Screening\n* A female subject must have a negative pregnancy test at Screening and on Day -1.\n* A female subject of childbearing potential must agree to use an accepted method of birth control (excluding hormonal birth control methods) from Screening through 30 days after final study drug administration.\n* Subject must have a body mass index (BMI) from 18.5 to 32.0 kg/m2 and a weight of\n\n ≥ 50 kg at Screening.\n* Subject must be able to provide informed consent after risks and benefits have been explained. Subject must also be willing and able to comply with the protocol requirements.\n* Subject must be in general good health as determined by the Investigator based on pre-study medical, medication, and surgical history; physical examination; and clinical laboratory tests.\n\nMain Exclusion Criteria:\n\n* Subject must not have been dosed with test drug or blinded study drug in another investigational study within 30 days or 5 half-lives of the biologic activity of the test drug, whichever is longer, before the time of first study dose.\n* Subject must not have a history of hypersensitivity to rolapitant IV or any of its excipients or who have completed a study visit as part of a previous rolapitant study within the 6 months prior to first study drug administration (Day\n* Subject must not have poor venous access or consider venipuncture intolerable.\n* Subject must not have a history of significant complications or anxiety associated with the IV administration of medications that, in the opinion of the Investigator, could make the subject unable to complete dosing requirements.\n* Subject must not be pregnant or lactating.'}, 'identificationModule': {'nctId': 'NCT02382666', 'briefTitle': 'A Phase 1, 2-Part, Single Ascending Dose Assessment of the Safety, Tolerability, and Pharmacokinetics of Rolapitant Intravenous in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tesaro, Inc.'}, 'officialTitle': 'A Phase 1, 2-Part, Single Ascending Dose Assessment of the Safety, Tolerability, and Pharmacokinetics of Rolapitant Intravenous in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'PR-11-5022-C'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rolapitant Cohort 1', 'description': 'Investigational Product: Rolapitant Dose 1 administered IV as a 30-minute infusion Dosage Form: 2 mg/mL solution', 'interventionNames': ['Drug: Rolapitant']}, {'type': 'EXPERIMENTAL', 'label': 'Rolapitant Cohort 2', 'description': 'Investigational Product: Rolapitant Dose 2 administered IV as a 30-minute infusion Dosage Form: 2 mg/mL solution', 'interventionNames': ['Drug: Rolapitant']}, {'type': 'EXPERIMENTAL', 'label': 'Rolapitant Cohort 3', 'description': 'Investigational Product: Rolapitant Dose 3 administered IV as a 30-minute infusion Dosage Form: 2 mg/mL solution', 'interventionNames': ['Drug: Rolapitant']}, {'type': 'EXPERIMENTAL', 'label': 'Rolapitant Cohort 4', 'description': 'Investigational Product: Rolapitant Dose 4 administered IV as a 30-minute infusion Dosage Form: 2 mg/mL solution', 'interventionNames': ['Drug: Rolapitant']}, {'type': 'EXPERIMENTAL', 'label': 'Rolapitant Cohort 5', 'description': 'Investigational Product: Rolapitant Dose 5 administered IV as a 30-minute infusion Dosage Form: 2 mg/mL solution', 'interventionNames': ['Drug: Rolapitant']}, {'type': 'EXPERIMENTAL', 'label': 'Rolapitant Cohort 6', 'description': 'Investigational Product: Rolapitant Dose 6 administered IV as a 30-minute infusion Dosage Form: 2 mg/mL solution', 'interventionNames': ['Drug: Rolapitant']}], 'interventions': [{'name': 'Rolapitant', 'type': 'DRUG', 'armGroupLabels': ['Rolapitant Cohort 1', 'Rolapitant Cohort 2', 'Rolapitant Cohort 3', 'Rolapitant Cohort 4', 'Rolapitant Cohort 5', 'Rolapitant Cohort 6']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21225', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Parexel', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Dennis Vargo, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Tesaro, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tesaro, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}