Bioequivalence Study - Reference Clinical Fexinidazole Tablet Versus Proposed Market Formulation

NCT02571062 | Completed Phase 1

• 1 other identifier: DNDiHATFEX008
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Trypanosomiasis, African

Keywords

bioequivalence

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

experimental formulation

EXPERIMENTAL

crossover design

Drug: Fexinidazole

final formulation

EXPERIMENTAL

crossover design

Drug: Fexinidazole

Interventions

Fexinidazole DRUG

experimental formulation; final formulation

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• All subjects to be of sub-Saharan African origins with both parents of sub- Saharan African origins too;
• Signed ICF;
• to 45 years old
• Male subjects with a BMI calculated as weight (kg)/height (m)2 from 18 to 28 kg/m2 at screening
• 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;
• 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;
• Normal ECG or, if abnormal, considered not clinically significant by the principal Investigator;
• Registered with the French Social Security in agreement with the French law on biomedical experimentation.

You may not qualify if:

• 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
• 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;
• 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 have a history of HAT;
• 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 have a positive alcohol breath test
• 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 already taken fexinidazole;
• Who have any clinical condition or prior therapy which, in the opinion of the Investigator, made the subject unsuitable for the study;

Sponsors & Collaborators

• Drugs for Neglected Diseases: lead

Study Sites (1)

Biotrial

Rennes, France

Location

MeSH Terms

Conditions

Trypanosomiasis, African

Interventions

fexinidazole

Condition Hierarchy (Ancestors)

Trypanosomiasis; Euglenozoa Infections; Protozoan Infections; Parasitic Diseases; Infections; Vector Borne Diseases

Study Officials

• Antoine Tarral, MD

  Drugs for Neglected Diseases

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2015
• First Posted: October 8, 2015
• Study Start: March 1, 2015
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: October 8, 2015

Record last verified: 2015-06

Locations

FR (1)