Trypanosomiasis, African Clinical Trial
Official title:
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
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.
Status | Completed |
Enrollment | 136 |
Est. completion date | March 2015 |
Est. primary completion date | March 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 45 Years |
Eligibility |
Inclusion Criteria: - Male healthy volunteers 18 to 45 years of age, - All subjects to be of sub-Saharan African origins with both parents of Sub-Saharan African origins too, - Male subjects with a body mass index (BMI) calculated as weight in kg/(height in m2) from 18 to 28 kg/m2 at screening, - Able to communicate well with the Investigator and research staff and to comply with the requirements of the entire study, - Provision of written informed consent to participate as shown by a signature on the volunteer consent form, - 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, - 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. - Registered with the French Social Security in agreement with the French law on biomedical experimentation. Exclusion Criteria: - 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, - Who previously received SCYX-7158, - 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…) - 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, - Who are within the exclusion period defined in the National Register for Healthy Volunteers of the French Ministry of Health, - Who forfeit their freedom by administrative or legal award or who were under guardianship, - Unwilling to give their informed consent, - Who have a positive laboratory test for Hepatitis B surface antigen (HbsAg), or anti-HIV 1/2 or anti- HCV antibodies - Who have a history of allergy, intolerance or photosensitivity to any drug, - Who have a history of serious allergy, asthma, allergic skin rash or sensitivity to any drug, - 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), - Who drink more than 8 cups daily of beverage containing caffeine, - Who have a positive laboratory test for urine drug screening (opiates, cocaine, amphetamine, cannabis, benzodiazepines), - Who have undergone surgery or have donated blood within 12 weeks prior to the start of the study, - 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, - Who have any clinical condition or prior therapy which, in the opinion of the Investigator, made the subject unsuitable for the study, - Who participated to any clinical trial with an investigational drug in the past 3 months preceding study entry. |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | Optimed | Grenoble | |
France | SGS Aster | Paris |
Lead Sponsor | Collaborator |
---|---|
Drugs for Neglected Diseases |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Occurence of adverse events (AEs) | 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). | 9 to 37 days, depending on the part of the study | Yes |
Secondary | Pharmacokinetic (blood concentration of SCYX-7158 and metabolite) | from pre-dose until 168 h post-dose. | No | |
Secondary | Pharmacokinetic (urine concentration of SCYX-7158 and metabolite) | from pre-dose until 168 h post-dose. | No |
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