Ignite Creation Date:
2025-12-24 @ 2:32 PM
Ignite Modification Date:
2026-04-08 @ 11:08 PM
Study NCT ID:
NCT01998659
Status:
COMPLETED
Last Update Posted:
2014-11-04
First Post:
2013-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single Ascending Oral Dose Phase I Study With Px-102
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000628793', 'term': 'PX-102'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-03', 'studyFirstSubmitDate': '2013-11-19', 'studyFirstSubmitQcDate': '2013-11-25', 'lastUpdatePostDateStruct': {'date': '2014-11-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and tolerability of Px-102', 'timeFrame': '24h', 'description': 'Adverse event monitoring, laboratory values, cardiovascular monitoring. Comparison of active vs. placebo'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics of Px-102 and metabolites', 'timeFrame': 'pre-dose (0 hours), 15 min, 30 min, 1, 1.5, 2, 4, 6, 8, 12, 24 hours after dosing', 'description': 'Plasma, Urine and fecal concentrations (ng/mL) of Px-102 and metabolites measured by LC-MS/MS. AUC, Cmax and other pk parameters, dose proportionality'}, {'measure': 'Pharmacodynamics', 'timeFrame': 'pre-dose (0 hours) and 1, 2, 4, 8, 12, and 24 hours', 'description': 'Markers for FXR activation (e.G. FGF19 concentrations (pg/mL) measured by ELISA); comparison active vs. placebo'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the safety and tolerability of the FXR agonist Px-102 in healthy subjects after single oral dosing.', 'detailedDescription': 'The study is a single-centre, double-blind, randomized, placebo-controlled, parallel group phase I study with healthy male subjects receiving ascending single oral oral doses of Px-102 to assess the safety and tolerability, pharmacokinetics and pharmacodynamics.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy male subject of caucasian origin 18 to 45 years of age\n* Good state of health (mentally and physically) as determined by medical history, physical examination, vital signs, ECG recording and clinical lab results.\n* BMI in between 20-29 kg/m² with absolute weight in between 70-120 kg.\n* Serum triglyceride, total cholesterol and liver enzyme levels (alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyltransferase (GGT), alkaline phosphatase (AP)) strictly within the normal ranges at screening and on Day -1.\n* HbA1c ≤ 6.5 %\n* Subject has been informed both verbally and in writing and has given written consent to participation in the study prior to start and any study-related procedure\n* Negative results for HIV- and Hepatitis-B and -C serology at screening\n\nExclusion Criteria:\n\n* Female gender\n* Use of prescription or non-prescription drugs within 7 days (30 if the drug is a possible enzyme inducer) prior to administration of study medication. Use of drugs known to induce steatosis (e.g. valproate, amiodarone or prednisone) or to affect body weight and carbohydrate metabolism\n* Any acute or chronic illness or clinically relevant finding at screening and at base line examination which may jeopardize the subject's participation in the study\n* History or presence of biliary obstruction or biliary disease, hepatic encephalopathy, advanced ascites, portal hypertension, esophageal/gastric variceal bleeding, hepatocellular carcinoma, previous liver transplantation or any other chronic liver disease\n* Renal dysfunction, e.g. glomerular filtration rate ≤ 80 ml/min/1,73m2 (as determined by the formula of Cockroft-Gault)\n* Type I or II Diabetes\n* Any clinically relevant abnormality on screening medical assessment, laboratory examination, 12-lead ECG Any clinically relevant finding in the baseline telemetry\n* Marked baseline prolongation of QT/QTc interval (QTc interval \\> 440 ms) in the 12-lead ECG using the Fridericia method for QTc analysis\n* Heart rate \\< 50 bpm.\n* Allergies (except for mild forms of hay fever) or history of hypersensitivity reactions\n* Smoking (regular or irregular) \\> 5 cigarettes (or equivalent) per day.\n* Excessive alcohol drinking (more than approximately 20 g alcohol per day), unable to refrain from alcohol drinking from 48 h prior to dosing until the last pharmacokinetic blood sample has been withdrawn\n* Positive test for drugs or alcohol at screening or prior to the dosing session\n* History of alcoholism or drug/chemical/substance abuse within past 2 years\n* Investigator deems the subject unable or unwilling to comply fully with the study protocol\n* Has received clinical study medication within the last 30 days prior to this study\n* Donation or loss of 400 ml or more of blood within eight (8) weeks prior to dosing\n* Allergic to any of the active or inactive ingredients in the study medication\n* Any other reason which the Investigator considers unsuitable for the subject to participate\n* All subjects (including male subjects with partners of childbearing potential) who do not use a highly effective method of birth control (failure rate less than 1 % per year when used consistently and correctly), e.g. implants, injectables, combined oral contraceptives in combination with a barrier method, some intrauterine contraceptive devices or sexual abstinence\n* Any condition or previous disease leading to puritus or itching of the skin."}, 'identificationModule': {'nctId': 'NCT01998659', 'briefTitle': 'Single Ascending Oral Dose Phase I Study With Px-102', 'organization': {'class': 'INDUSTRY', 'fullName': 'Phenex Pharmaceuticals AG'}, 'officialTitle': 'A Double-blind, Randomized, Placebo-controlled, Dose-escalation Study of the Safety, Tolerability and Pharmacokinetics of Increasing Single Oral Doses of Px-102 to Healthy Subjects', 'orgStudyIdInfo': {'id': 'PHS-Px-102-I-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Px-102', 'description': 'Px-102 drinking solution, single dose', 'interventionNames': ['Drug: Px-102']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo drinking solution, single dose', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Px-102', 'type': 'DRUG', 'description': 'Px-102 drinking solution, 7 single ascending doses from 0.15 mg/kg up to 4.5 mg/kg', 'armGroupLabels': ['Px-102']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Oral drinking solution', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Neuss', 'country': 'Germany', 'facility': 'FOCUS Clinical Drug Development GmbH', 'geoPoint': {'lat': 51.19807, 'lon': 6.68504}}], 'overallOfficials': [{'name': 'Claus Kremoser, Dr.', 'role': 'STUDY_CHAIR', 'affiliation': 'Phenex Pharmaceuticals AG'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Phenex Pharmaceuticals AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}