Ignite Creation Date:
2025-12-24 @ 12:21 PM
Ignite Modification Date:
2025-12-27 @ 10:45 PM
Study NCT ID:
NCT01533961
Status:
COMPLETED
Last Update Posted:
2015-09-18
First Post:
2012-02-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Human African Trypanosomiasis: First in Man Clinical Trial of a New Medicinal Product, the SCYX-7158
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014352', 'term': 'Trypanosomiasis'}, {'id': 'D014353', 'term': 'Trypanosomiasis, African'}, {'id': 'D011528', 'term': 'Protozoan Infections'}, {'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D058069', 'term': 'Neglected Diseases'}], 'ancestors': [{'id': 'D056986', 'term': 'Euglenozoa Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C557508', 'term': 'SCYX 7158'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 136}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-17', 'studyFirstSubmitDate': '2012-02-13', 'studyFirstSubmitQcDate': '2012-02-15', 'lastUpdatePostDateStruct': {'date': '2015-09-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-02-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurence of adverse events (AEs)', 'timeFrame': '9 to 37 days, depending on the part of the study', 'description': 'Monitoring for the occurrence of AEs. Changes in physical examination, vital signs (blood pressure and pulse rate), ECG, and clinical laboratory tests (biochemistry, hematology, and urinalysis).'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetic (blood concentration of SCYX-7158 and metabolite)', 'timeFrame': 'from pre-dose until 168 h post-dose.'}, {'measure': 'Pharmacokinetic (urine concentration of SCYX-7158 and metabolite)', 'timeFrame': 'from pre-dose until 168 h post-dose.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['neglected disease', 'africa', 'new drug', 'oral drug', 'parasite'], 'conditions': ['Trypanosomiasis', 'Trypanosomiasis, African', 'Protozoan Infections', 'Parasitic Diseases']}, 'referencesModule': {'references': [{'pmid': '36763327', 'type': 'DERIVED', 'citation': 'Tarral A, Hovsepian L, Duvauchelle T, Donazzolo Y, Latreille M, Felices M, Gualano V, Delhomme S, Valverde Mordt O, Blesson S, Voiriot P, Strub-Wourgaft N. Determination of the Optimal Single Dose Treatment for Acoziborole, a Novel Drug for the Treatment of Human African Trypanosomiasis: First-in-Human Study. Clin Pharmacokinet. 2023 Mar;62(3):481-491. doi: 10.1007/s40262-023-01216-8. Epub 2023 Feb 10.'}], 'seeAlsoLinks': [{'url': 'http://www.dndi.org', 'label': 'Sponsor website'}]}, 'descriptionModule': {'briefSummary': 'This study is aimed at assessing the tolerability and pharmacokinetic parameters of SCYX-7158 in healthy volunteers. In animal models of both acute and chronic experimental Trypanosomiasis infections, SCYX-7158 shows highly promising efficacy.', 'detailedDescription': 'The present study is designed to obtain safety, tolerability and PK data after single oral administration of increasing doses of SCYX-7158 in healthy male sub-Saharan African subjects. This study will also assess the impact on the relative bioavailability of SCYX-7158 administered as a capsule after single oral dose administration.\n\nThe study will be divided in 3 different parts. Study Part I will be a randomized, double-blind, placebo-controlled, single ascending dose study with SCYX-7158 administered as a capsule.\n\nA other part is scheduled to evaluate the impact of activated charcoal intake on the PK characteristics of SCYX-7158 and determine the most adapted treatment schedule for charcoal to enhance SCYX-7158 elimination while allowing a sustained drug exposure likely to be therapeutically active.\n\nA last part is planned to evaluate the pharmacokinetics of a new formulation (tablet) of SCYX-7158 in healthy male volunteers'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male healthy volunteers 18 to 45 years of age,\n* All subjects to be of sub-Saharan African origins with both parents of Sub-Saharan African origins too,\n* Male subjects with a body mass index (BMI) calculated as weight in kg/(height in m2) from 18 to 28 kg/m2 at screening,\n* Able to communicate well with the Investigator and research staff and to comply with the requirements of the entire study,\n* Provision of written informed consent to participate as shown by a signature on the volunteer consent form,\n* Light smokers (less than 5 cigarettes per day) or subjects who are non-smokers. No smoking (or use of smoking substitute e.g. nicotine patch) is permitted from screening throughout the study,\n* Normal arterial blood pressure (BP) and pulse rate or, if abnormal, considered not clinically significant by the principal Investigator. These will be measured after resting for 5 min.\n* Registered with the French Social Security in agreement with the French law on biomedical experimentation.\n\nExclusion Criteria:\n\n* Who on direct questioning and physical examination have evidence of any clinically significant acute or chronic disease, including known or suspected HIV, HBV or HCV infection,\n* Who previously received SCYX-7158,\n* Who presented acute or chronic or history of symptoms of Gastro intestinal disturbances (GI) or on physical examination have evidence of any clinical signs of acute or chronic GI abnormality ( i.e hemorrhoids, GI bleeding…)\n* With any clinically significant abnormality following review of pre-study laboratory tests (aspartate aminotransferase (ASAT) and alanine aminotransferase (ALAT) must be within normal ranges), vital signs, full physical examination and ECG,\n* Who are within the exclusion period defined in the National Register for Healthy Volunteers of the French Ministry of Health,\n* Who forfeit their freedom by administrative or legal award or who were under guardianship,\n* Unwilling to give their informed consent,\n* Who have a positive laboratory test for Hepatitis B surface antigen (HbsAg), or anti-HIV 1/2 or anti- HCV antibodies\n* Who have a history of allergy, intolerance or photosensitivity to any drug,\n* Who have a history of serious allergy, asthma, allergic skin rash or sensitivity to any drug,\n* Who are known or suspected alcohol or drug abusers (more than 14 units of alcohol per week, one unit = 8 g or about 10 mL of pure alcohol),\n* Who drink more than 8 cups daily of beverage containing caffeine,\n* Who have a positive laboratory test for urine drug screening (opiates, cocaine, amphetamine, cannabis, benzodiazepines),\n* Who have undergone surgery or have donated blood within 12 weeks prior to the start of the study,\n* Who have taken any prescribed or over the counter drug (including antacid drug), with the exception of paracetamol (up to 3 g per day) within 2 weeks prior to the first dose administration,\n* Who have any clinical condition or prior therapy which, in the opinion of the Investigator, made the subject unsuitable for the study,\n* Who participated to any clinical trial with an investigational drug in the past 3 months preceding study entry.'}, 'identificationModule': {'nctId': 'NCT01533961', 'briefTitle': 'Human African Trypanosomiasis: First in Man Clinical Trial of a New Medicinal Product, the SCYX-7158', 'organization': {'class': 'OTHER', 'fullName': 'Drugs for Neglected Diseases'}, 'officialTitle': 'Randomized, Double-blind, Placebo-controlled Sequential Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SCYX-7158 After Single Oral Ascending Doses in Healthy Male Volunteers', 'orgStudyIdInfo': {'id': 'DNDiOXA001'}, 'secondaryIdInfos': [{'id': '2011-004639-30', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SCYX-7158', 'description': 'In each dose group (8 subjects) , 6 Healthy Volunteers receive SCYX-7158', 'interventionNames': ['Drug: SCYX-7158']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo of SCYX-7158', 'description': 'In each dose group (8 subjects) , 2 Healthy Volunteers receive placebo of SCYX-7158', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'SCYX-7158', 'type': 'DRUG', 'armGroupLabels': ['SCYX-7158']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo of SCYX-7158']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Grenoble', 'country': 'France', 'facility': 'Optimed', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'city': 'Paris', 'country': 'France', 'facility': 'SGS Aster', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Antoine Tarral, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Drugs for Neglected Diseases initiative'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Drugs for Neglected Diseases', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}