Ignite Creation Date:
2025-12-24 @ 6:33 PM
Ignite Modification Date:
2025-12-30 @ 3:17 AM
Study NCT ID:
NCT01340157
Status:
COMPLETED
Last Update Posted:
2017-03-31
First Post:
2011-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fexinidazole (1200mg) Bioavailability Under Different Food Intake Conditions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C038307', 'term': 'fexinidazole'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-04', 'completionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-29', 'studyFirstSubmitDate': '2011-04-14', 'studyFirstSubmitQcDate': '2011-04-20', 'lastUpdatePostDateStruct': {'date': '2017-03-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-04-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma concentration measurement of fexinidazole, fexinidazole sulfoxide and sulfone metabolites after a single oral dose of fexinidazole (1200mg) administration and under different food intake conditions'}], 'secondaryOutcomes': [{'measure': 'Occurence of AEs', 'description': 'To assess safety and tolerability of fexinidazole tablets administered as single oral dose under fasting conditions and after two different meals in healthy male volunteers.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Fexinidazole', 'Phase I', 'Bioavailability study', 'Food effect', 'Human African Trypanosomiasis'], 'conditions': ['PK in Healthy Volunteers']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.dndi.org', 'label': 'Sponsor website'}, {'url': 'http://www.dndi.org/wp-content/uploads/2009/06/ClinicalPK_Tarral_FexinidazoleHAT_2014.pdf', 'label': 'Publication combining results of NCT00982904 \\& NCT01483170'}]}, 'descriptionModule': {'briefSummary': 'The present study is designed to assess the impact of concomitant food intake on the relative bioavailability of a single oral fexinidazole tablet administration.'}, '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 10 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 Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) infection,\n* With any clinically significant abnormality following review of pre-study laboratory tests (aspartate aminotransferase (ASAT), alanine aminotransferase (ALAT) and alkaline phosphatase (ALP) must be within normal ranges), vital signs, full physical examination and Electrocardiogram (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': 'NCT01340157', 'briefTitle': 'Fexinidazole (1200mg) Bioavailability Under Different Food Intake Conditions', 'organization': {'class': 'OTHER', 'fullName': 'Drugs for Neglected Diseases'}, 'officialTitle': 'Randomized, Open Study to Assess the Impact of Two Different Types of Food on the Relative Bioavailability of Fexinidazole Tablets After Single Oral Dose in Healthy Male Volunteers', 'orgStudyIdInfo': {'id': 'DNDiFEX002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fasting', 'description': 'Treatment A: 1200mg fexinidazole administered in fasting conditions by oral route', 'interventionNames': ['Drug: Fexinidazole']}, {'type': 'EXPERIMENTAL', 'label': 'Meal 1: Plumpy Nuts', 'description': 'Treatment B: 1200mg fexinidazole administered in fed conditions (meal 1) by oral route', 'interventionNames': ['Drug: Fexinidazole']}, {'type': 'EXPERIMENTAL', 'label': 'Meal 2: Rice + beans', 'description': 'Treatment B: 1200mg fexinidazole administered in fed conditions (meal 2) by oral route', 'interventionNames': ['Drug: Fexinidazole']}], 'interventions': [{'name': 'Fexinidazole', 'type': 'DRUG', 'description': 'Single oral dose of 1200mg fexinidazole consisting of 2 tablets dosed at 600mg per tablet.', 'armGroupLabels': ['Fasting', 'Meal 1: Plumpy Nuts', 'Meal 2: Rice + beans']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75015', 'city': 'Paris', 'country': 'France', 'facility': 'SGS Aster s.a.s.', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Lionel Hovsepian, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'SGS Aster'}, {'name': 'Antoine Tarral, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Drugs for Neglected Diseases initiative'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Drugs for Neglected Diseases', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sanofi', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Antoine Tarral, MD', 'oldOrganization': 'Drugs for Neglected Diseases Initiative'}}}}