Ignite Creation Date:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2025-12-26 @ 11:13 PM
Study NCT ID:
NCT04935112
Status:
COMPLETED
Last Update Posted:
2022-08-26
First Post:
2021-06-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Explore the Effect of Acid-reducing Agents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000611865', 'term': 'sitravatinib'}, {'id': 'D000077402', 'term': 'Pantoprazole'}, {'id': 'D015738', 'term': 'Famotidine'}], 'ancestors': [{'id': 'D053799', 'term': '2-Pyridinylmethylsulfinylbenzimidazoles'}, {'id': 'D013454', 'term': 'Sulfoxides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D001393', 'term': 'Azoles'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': '2 period crossover'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-07-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-24', 'studyFirstSubmitDate': '2021-06-10', 'studyFirstSubmitQcDate': '2021-06-10', 'lastUpdatePostDateStruct': {'date': '2022-08-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics - Cmax (sitravatinib)', 'timeFrame': 'Up to Day 7 after dosing', 'description': 'Maximum observed plasma concentration'}, {'measure': 'Pharmacokinetics - AUC∞ (sitravatinib)', 'timeFrame': 'Up to 72 hours after dosing', 'description': 'Area under the plasma concentration-time curve from time zero extrapolated to infinity'}, {'measure': 'Pharmacokinetics - AUClast (sitravatinib)', 'timeFrame': 'Up to 72 hours after dosing', 'description': 'Area under the curve from time zero to the last measured time point'}], 'secondaryOutcomes': [{'measure': 'Adverse Events (AEs)', 'timeFrame': 'Up to 9 weeks from screening', 'description': 'Incidence and severity of AEs'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Adults']}, 'descriptionModule': {'briefSummary': 'A Phase 1 Study of the Effect of Acid-reducing Agents on the Pharmacokinetics of a Single Oral Dose of Sitravatinib in Healthy Adult Subjects. The study is a single-center, open-label, 2-period, 2-treatment, fixed-sequence crossover, parallel-group study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n* Body mass index between 18.0 and 32.0 kg/m2, inclusive.\n* In good health, determined by no clinically significant findings from medical history, physical examination, 12 lead ECG, vital sign measurements, and clinical laboratory evaluations at screening and/or check-in, as assessed by the investigator (or qualified designee).\n* Females of childbearing potential will not be pregnant or lactating and must have a negative result on an approved pregnancy test at screening and check-in. Females of childbearing potential must agree to use contraception.\n* Male subjects must agree to use contraception.\n* Able to comprehend and willing to sign an ICF and to abide by the study restrictions.\n\nKey Exclusion Criteria:\n\n* Significant history of clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator.\n* History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, any components of the IMP, or other substance (not including seasonal allergies), unless approved by the investigator.\n* History of intestinal disease, inflammatory bowel disease, major gastric surgery, or other gastrointestinal conditions (eg, uncontrolled nausea, vomiting, malabsorption syndrome) likely to alter absorption of study treatment or result in inability to swallow oral medications. (Uncomplicated appendectomy and hernia repair are allowed. Cholecystectomy is not allowed.)\n* History of Gilbert's syndrome or suspicion of Gilbert's syndrome based on elevated total and indirect bilirubin (may be confirmed by repeat).\n* Use or intend to use any medications/products known to alter drug absorption, metabolism, or elimination processes, including St. John's wort, within 30 days prior to study drug administration on Day 1 of Period 1."}, 'identificationModule': {'nctId': 'NCT04935112', 'briefTitle': 'A Study to Explore the Effect of Acid-reducing Agents', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mirati Therapeutics Inc.'}, 'officialTitle': 'A Phase 1 Study of the Effect of Acid-reducing Agents on the Pharmacokinetics of a Single Oral Dose of Sitravatinib in Healthy Adult Subjects', 'orgStudyIdInfo': {'id': '516-011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1 Treatment A (sitravatinib only)', 'description': 'Period 1: A single oral dose of 100 mg sitravatinib on Day 1', 'interventionNames': ['Drug: Sitravatinib']}, {'type': 'EXPERIMENTAL', 'label': 'Group 1 Treatment B (sitravatinib and pantoprazole)', 'description': 'Period 2: Oral pantoprazole once daily for 7 days (Days 1 to 7) and a single oral dose of 100 mg sitravatinib on Day 7', 'interventionNames': ['Drug: Sitravatinib', 'Drug: Pantoprazole']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2 Treatment C (sitravatinib only)', 'description': 'Period 1: A single oral dose of 100 mg sitravatinib on Day 1', 'interventionNames': ['Drug: Sitravatinib']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2 Treatment D (sitravatinib and famotidine)', 'description': 'Period 2: A single oral dose of 100 mg sitravatinib followed by a single oral dose of famotidine 40 mg approximately 2 hours after sitravatinib dose on Day 1', 'interventionNames': ['Drug: Sitravatinib', 'Drug: Famotidine']}], 'interventions': [{'name': 'Sitravatinib', 'type': 'DRUG', 'otherNames': ['MGCD516'], 'description': '100 mg sitravatinib on Day 1', 'armGroupLabels': ['Group 1 Treatment A (sitravatinib only)', 'Group 1 Treatment B (sitravatinib and pantoprazole)', 'Group 2 Treatment C (sitravatinib only)', 'Group 2 Treatment D (sitravatinib and famotidine)']}, {'name': 'Pantoprazole', 'type': 'DRUG', 'otherNames': ['Protonix'], 'description': '40 mg QD on Day 1 to Day 7 of Period 2 in Group 1', 'armGroupLabels': ['Group 1 Treatment B (sitravatinib and pantoprazole)']}, {'name': 'Famotidine', 'type': 'DRUG', 'otherNames': ['Pepcid'], 'description': '40 mg PO 2 hrs after sitravatinib in Period 2 of Group 2', 'armGroupLabels': ['Group 2 Treatment D (sitravatinib and famotidine)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53704', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Covance Clinical Research Unit Inc.', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Curtis Chin, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Mirati Therapeutics Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mirati Therapeutics Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}