Ignite Creation Date:
2025-12-24 @ 5:47 PM
Ignite Modification Date:
2026-02-21 @ 11:19 PM
Study NCT ID:
NCT02255968
Status:
TERMINATED
Last Update Posted:
2015-05-12
First Post:
2014-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Safety, Tolerability, and Pharmacokinetics of Multiple Oral Doses of EDP-788
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']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-08', 'studyFirstSubmitDate': '2014-07-29', 'studyFirstSubmitQcDate': '2014-10-02', 'lastUpdatePostDateStruct': {'date': '2015-05-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence and severity of adverse events', 'timeFrame': 'From time of dosing to 20-23 days after receiving last dose of study drug'}], 'secondaryOutcomes': [{'measure': 'Changes from baseline in laboratory values and vital signs', 'timeFrame': 'From time of dosing to 20-23 days after receiving last dose of study drug'}, {'measure': 'Pharmacokinetic parameters', 'timeFrame': 'From time of dosing to 3 days after receiving the last dose of study drug', 'description': 'As measured by peak plasma concentration (Cmax)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Normal Volunteers', 'Safety', 'Pharmacokinetics'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The primary objective of the study is to determine the safety and tolerability of multiple doses of orally administered EDP-788. Secondary objectives of the study are to describe the pharmacokinetics of EDP-788 (and its metabolite EDP-322) after multiple doses of orally administered drug.', 'detailedDescription': 'Three cohorts of subjects will be enrolled to receive either EDP-788 or placebo. The dose of EDP-788 will be increased with each successive cohort. In addition, a 4th cohort may be enrolled, depending on clinical findings (tolerability, safety, pharmacokinetics) observed in the first 3 cohorts. In each cohort, 8 subjects will receive a q12h oral dose regimen of EDP-788 (6 subjects) or placebo (2 subjects). All subjects receive multiple doses of study drug (EDP-788 or placebo).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* In good general health\n* BMI between 18 - 32 kg/m2\n* Women must be of non-childbearing potential (surgically sterilized)\n* Normal electrocardiogram\n* Willing to abstain from strenuous physical exercise starting 3 days prior to admission to the study clinic through the 17 - 19 day post-dosing visit\n\nKey Exclusion Criteria:\n\n* Hypersensitivity to macrolide antibiotics\n* Abnormal laboratory values\n* Gastroenteritis within 1 week of study drug administration\n* Use of any investigational drugs within 28 days of study drug administration\n* History of gastrointestinal surgery which may interfere with drug absorption\n* Active Hepatitis B, Hepatitis C, or HIV infection\n* Use of prescription or non-prescription drugs within 14 days of study drug administration\n* Use of nicotine within 3 months of study drug administration'}, 'identificationModule': {'nctId': 'NCT02255968', 'briefTitle': 'Evaluation of the Safety, Tolerability, and Pharmacokinetics of Multiple Oral Doses of EDP-788', 'organization': {'class': 'INDUSTRY', 'fullName': 'Enanta Pharmaceuticals, Inc'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, Ascending Multiple-Dose Safety, Tolerability, and Pharmacokinetic Study of EDP-788 in Healthy Adult Volunteers', 'orgStudyIdInfo': {'id': 'EDP788-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EDP-788', 'description': 'Multiple doses with dose escalation to continue in successive cohorts', 'interventionNames': ['Drug: EDP-788']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Multiple doses with dose escalation to continue in successive cohorts', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'EDP-788', 'type': 'DRUG', 'description': 'EDP-788 Capsules. All interventions are given as multiple doses.', 'armGroupLabels': ['EDP-788']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matching placebo capsules. All interventions are given as multiple doses', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78744', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'PPD Phase 1 Clinic', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Enanta Pharmaceuticals, Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}