Trypanosomiasis, African Clinical Trial
Official title:
A Bioequivalence Study of the Reference Clinical Fexinidazole Tablet vs Proposed Market Formulation in Healthy Male Volunteers of African Sub-Saharan Origin:an Open-label,Randomized,Two-treatment,Single Dose,Replicate Design,Fed Condition
Phase 1 bioequivalence (BE) study. This study is for regulatory purpose to determine BE of
the tablet formulation used in the clinical trials and the final marketed tablet formulation
under fed condition.
The study will be an open-label, 2-treatment, 2-sequence, 4-period, single-dose, replicate
crossover study under fed condition. The 4-period sequences for the replicate design will be
TRTR and RTRT, where R designates the reference formulation and T the test formulation.
Subject will be allocated randomly to one of the two sequences of treatments according to
the randomization list.
Status | Completed |
Enrollment | 30 |
Est. completion date | June 2015 |
Est. primary completion date | June 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 45 Years |
Eligibility |
Inclusion Criteria: 1. All subjects to be of sub-Saharan African origins with both parents of sub- Saharan African origins too; 2. Signed ICF; 3. 18 to 45 years old 4. Male subjects with a BMI calculated as weight (kg)/height (m)2 from 18 to 28 kg/m2 at screening 5. Light smokers (less than 5 cigarettes per day, or equivalent e-cigarettes or nicotine patch) or subjects who are non-smokers. No smoking (or use of smoking substitute e.g. nicotine patch) is permitted from screening throughout the study; 6. Normal arterial BP and pulse rate or, if abnormal, considered not clinically significant by the principal Investigator. These will be measured after resting for 5 min; 7. Normal ECG or, if abnormal, considered not clinically significant by the principal Investigator; 8. Registered with the French Social Security in agreement with the French law on biomedical experimentation. Exclusion Criteria: 1. 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 2. With any clinically significant abnormality following review of pre-study laboratory tests (ASAT, ALAT) must be within normal ranges), vital signs, full physical examination and ECG; 3. Who are within the exclusion period defined in the National Register for Healthy Volunteers of the French Ministry of Health; 4. Unwilling to give their informed consent; 5. Who have a positive laboratory test for Hepatitis B surface antigen (HbsAg), or anti-HIV 1/2 or anti- HCV antibodies; 6. Who have a history of allergy, intolerance or photosensitivity to any drug; 7. Who have a history of serious allergy, asthma, allergic skin rash or sensitivity to any drug; 8. Who have a history of HAT; 9. 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); 10. Who have a positive alcohol breath test 11. Who drink more than 8 cups daily of beverage containing caffeine; 12. Who have a positive laboratory test for urine drug screening (opiates, cocaine, amphetamine, cannabis, benzodiazepines); 13. Who have undergone surgery or have donated blood within 12 weeks prior to the start of the study; 14. 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; 15. Who have already taken fexinidazole; 16. Who have any clinical condition or prior therapy which, in the opinion of the Investigator, made the subject unsuitable for the study; 17. Who participated to any clinical trial with an investigational drug in the past 3 months preceding the first study drug administration. |
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
France | Biotrial | Rennes |
Lead Sponsor | Collaborator |
---|---|
Drugs for Neglected Diseases |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pharmacokinetic parameters of fexinidazole following single dose | Area Under the Curve (AUC) | Pharmacokinetic sampling: Pre-dose, and 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 120 and 168 h | No |
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