Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-26 @ 3:28 AM
Study NCT ID:
NCT01115920
Status:
COMPLETED
Last Update Posted:
2010-11-18
First Post:
2010-04-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study to Evaluate Safety, Tolerability, and Pharmacokinetics (PK) of Intravenous (IV) Infusion of MTP-131 (Bendavia™) in Healthy Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C506540', 'term': "arginyl-2,'6'-dimethyltyrosyl-lysyl-phenylalaninamide"}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-11', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-11-17', 'studyFirstSubmitDate': '2010-04-30', 'studyFirstSubmitQcDate': '2010-05-03', 'lastUpdatePostDateStruct': {'date': '2010-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment emergent adverse events in treatment group versus placebo group', 'timeFrame': '7 days', 'description': 'Safety assessments including vital signs, physical exam,12-lead ECG, serum chemistry, hematology, and urinalysis will be collected the day prior to and for 7 days following study drug infusion. These parameters will be assessed for clinically significant abnormalities.'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics of MTP-131 including Css, Cmax, tmax, t½, AUC and dose proportionality.', 'timeFrame': 'Pre-infusion through 32 hours post infusion', 'description': 'Css (plasma steady state concentration), Cmax (observed peak plasma concentration), tmax (time of observed peak), AUC0-t (area under the plasma concentration time curve from time zero to the last quantifiable timepoint), AUC0-∞ (area under the plasma concentration time curve from time zero to infinity), λz (terminal \\[or elimination rate\\] phase rate constant), t½ (terminal half-life), CL (plasma clearance) and Vss (volume of distribution at steady state) will be determined for MTP-131. Ae (amount excreted in the urine) and CLr (renal clearance) may also be evaluated.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Drug Safety', 'Clinical Trial, Phase I', 'Nontherapeutic Human Experimentation', 'Heading Pharmacokinetics', 'Phase I Safety and Tolerability'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This is the first study of MTP-131 (Bendavia™) in humans. The objective of this study is to evaluate the safety, tolerability, and pharmacokinetics of escalating single intravenous infusion doses of MTP-131.', 'detailedDescription': 'The primary objective of the study is to evaluate the safety and tolerability of MTP-131 in healthy volunteers following a single intravenous infusion. The secondary objective is to evaluate the pharmacokinetics of MTP-131. This is a double-blind, placebo-controlled, randomized trial. A total of 40 eligible subjects will be enrolled and randomized in a 3:1 active to placebo ratio for a total of 5 treatment groups of 8 volunteers. As far as is logistically possible, each treatment group will have similar numbers of male and female volunteers. After the last subject for each cohort has completed the day 3 clinical assessment and no stopping rules have been met according to Safety Review Board decision, the next cohort will commence.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adult males or females age ≥18 years of age with signed informed consent.\n* Women who are not post-menopausal or surgically sterile must have a negative serum pregnancy test at screening and within 24 hours of treatment and who agree to use effective contraception for 30 days following the study.\n\nExclusion Criteria:\n\n* Clinically significant laboratory abnormalities,\n* Clinically significant abnormalities on physical examination,\n* BMI of less than 18 kg/m2 or greater than 32 kg/m2,\n* Any disease or condition that might compromise the cardiovascular, hematological, renal, hepatic, pulmonary (including chronic asthma), endocrine (e.g., diabetes), central nervous, or gastrointestinal (including an ulcer) systems,\n* History of seizures or epilepsy,\n* History of serious mental illness,\n* Participant in unrelated research involving investigational product within 30 days before planned date of drug administration,\n* Positive serology for HIV 1, HIV 2, HBsAg, or HCV,\n* Fever greater than 37.5°C at the time of planned dosing,\n* Suspicion of or recent history of alcohol or substance abuse,\n* Donated blood or blood products within the past 30 days,\n* Women who are pregnant or breastfeeding,\n* Employee or family member of the investigational site, and\n* Subjects who currently smoke cigarettes, cigars, pipes or chew tobacco products,\n* Subjects who are either unwilling to agree to refrain from use or found to be using:\n\n 1. Alcohol, caffeine, xanthine-containing food or beverages, nicotine products and over-the-counter medications with the exception of Tylenol from 24 hours prior to dosing and throughout the confinement period\n 2. Prescription medications from 14 days prior to and 7 days post treatment\n 3. Oral contraceptives without concomitant use of double-barrier contraceptives (condom, diaphragm with spermicide) for a period of 7 days prior to and 30 days post treatment'}, 'identificationModule': {'nctId': 'NCT01115920', 'briefTitle': 'Study to Evaluate Safety, Tolerability, and Pharmacokinetics (PK) of Intravenous (IV) Infusion of MTP-131 (Bendavia™) in Healthy Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'Stealth BioTherapeutics Inc.'}, 'officialTitle': 'A Phase I Study in Healthy Male and Healthy Female Subjects to Characterize the Safety, Tolerability, and Pharmacokinetics of Intravenous Infusion of MTP-131 (Bendavia™) Using a Randomized, Double-Blind, Placebo-Controlled, Parallel Group Design', 'orgStudyIdInfo': {'id': 'SPIRI-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'description': 'Cohort 1, Dose 0.010 mg/kg/hr Active (6), Placebo (2), Total Subjects (8)', 'interventionNames': ['Drug: MTP-131 (Bendavia™)']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2', 'description': 'Cohort 2, Dose 0.025 mg/kg/hr Active (6), Placebo (2), Total Subjects (8)', 'interventionNames': ['Drug: MTP-131 (Bendavia™)']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 3', 'description': 'Cohort 3, Dose 0.050 mg/kg/hr Active (6), Placebo (2), Total Subjects (8)', 'interventionNames': ['Drug: MTP-131 (Bendavia™)']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 4', 'description': 'Cohort 4, Dose 0.100 mg/kg/hr Active (6), Placebo (2), Total Subjects (8)', 'interventionNames': ['Drug: MTP-131 (Bendavia™)']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 5', 'description': 'Cohort 5, Dose 0.250 mg/kg/hr Active (6), Placebo (2), Total Subjects (8)', 'interventionNames': ['Drug: MTP-131 (Bendavia™)']}], 'interventions': [{'name': 'MTP-131 (Bendavia™)', 'type': 'DRUG', 'description': 'Single 4 hour intravenous infusion', 'armGroupLabels': ['Arm 1', 'Arm 2', 'Arm 3', 'Arm 4', 'Arm 5']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33014-3616', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Pharmacology of Miami, Inc.', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'overallOfficials': [{'name': 'Kenneth Lasseter, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinical Pharmacology of Miami, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stealth BioTherapeutics Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Richard Straube, MD, Chief Medical Officer', 'oldOrganization': 'Stealth Peptides, Inc.'}}}}