Ignite Creation Date:
2025-12-26 @ 2:42 PM
Ignite Modification Date:
2025-12-26 @ 2:42 PM
Study NCT ID:
NCT01524406
Status:
TERMINATED
Last Update Posted:
2014-07-15
First Post:
2012-01-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety Study of HPP593 in Subjects During and After Limb Immobilization
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D018476', 'term': 'Hypokinesia'}], 'ancestors': [{'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D020820', 'term': 'Dyskinesias'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-14', 'studyFirstSubmitDate': '2012-01-27', 'studyFirstSubmitQcDate': '2012-01-30', 'lastUpdatePostDateStruct': {'date': '2014-07-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-02-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety Evaluation', 'timeFrame': 'Baseline to Day 42', 'description': 'Number and severity of adverse events across trial period'}], 'secondaryOutcomes': [{'measure': 'Change in Muscle Strength', 'timeFrame': 'Day 1 to Day 42'}, {'measure': 'Changes on Muscle Related Biomarkers', 'timeFrame': 'Day 1 to Day 29'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Muscle Atrophy'], 'conditions': ['Muscle Atrophy', 'Hypodynamia']}, 'descriptionModule': {'briefSummary': 'This is a safety and tolerability study investigating the effect of HPP593 in healthy volunteers during and after limb immobilization.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Non-smoking.\n* Subjects must be in good health, as determined by medical history, physical examination, vital signs, electrocardiogram (ECG), and clinical test results.\n* Not restricted to a wheel-chair or confined to a bed.\n* Weight ≥ 50.0 kg.\n* BMI between 18 and 27.5 kg/m2, inclusive, at the time of screening.\n\nExclusion Criteria:\n\n* Any of the following abnormalities at Screening Visit and Baseline:\n\n * Fasting glucose \\> 110 mg/dL (Screening visit only).\n * Serum creatinine \\> 1.5 mg/dL. If serum creatinine is \\>1.5 mg/dL and creatinine clearance is \\>60 mL/min, the subject need not be excluded\n * Troponin I level above the upper limit of normal (ULN)\n * Liver function tests (LFTs) \\> 1.5x ULN\n* Evidence of significant organ system dysfunction (e.g. diabetes, cardiovascular disease, cirrhosis, hypogonadism, hypo- or hyperthyroidism; hypertension)\n* Any fluctuations in weight (no more than ± 2% of body weight) by subject self report in the 3 months prior to the Screening Visit.\n* Has received HPP593 in a previous clinical trial.\n* Smoking within 6 month prior to Day -1.\n* Michigan Alcohol Screening Test score greater than 2.'}, 'identificationModule': {'nctId': 'NCT01524406', 'briefTitle': 'Safety Study of HPP593 in Subjects During and After Limb Immobilization', 'organization': {'class': 'INDUSTRY', 'fullName': 'High Point Pharmaceuticals, LLC.'}, 'officialTitle': 'A Randomized, Double-blind, Placebo Controlled, Phase I Study to Evaluate the Safety and Tolerability of 28 Day Treatment With HPP593 Capsules in Healthy Volunteers During and After Limb Immobilization', 'orgStudyIdInfo': {'id': 'HPP593-103'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HPP593', 'interventionNames': ['Drug: HPP593']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'HPP593', 'type': 'DRUG', 'description': 'Oral, twice a day.', 'armGroupLabels': ['HPP593']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Oral, twice a day.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine Division of Geriatrics and Nutritional Studies', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'overallOfficials': [{'name': 'Shulin Wang, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'High Point Pharmaceuticals, LLC.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'High Point Pharmaceuticals, LLC.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}