Human African Trypanosomiasis: First in Man Clinical Trial of a New Medicinal Product, the SCYX-7158

Sponsor

Drugs for Neglected Diseases (Other)

Overall Status

Completed

CT.gov ID

NCT01533961

Collaborator

(none)

136

Enrollment

Locations

Arms

36.9

Duration (Months)

Patients Per Site

1.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Trypanosomiasis Trypanosomiasis, African Protozoan Infections Parasitic Diseases	Drug: SCYX-7158 Drug: Placebo	Phase 1

Detailed Description

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.

The 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.

A 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.

A last part is planned to evaluate the pharmacokinetics of a new formulation (tablet) of SCYX-7158 in healthy male volunteers

Study Design

Study Type:

Interventional

Actual Enrollment :

136 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Study Start Date :

Feb 1, 2012

Actual Primary Completion Date :

Mar 1, 2015

Actual Study Completion Date :

Mar 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SCYX-7158 In each dose group (8 subjects) , 6 Healthy Volunteers receive SCYX-7158	Drug: SCYX-7158
Placebo Comparator: Placebo of SCYX-7158 In each dose group (8 subjects) , 2 Healthy Volunteers receive placebo of SCYX-7158	Drug: Placebo

Arm

Intervention/Treatment

Experimental: SCYX-7158

In each dose group (8 subjects) , 6 Healthy Volunteers receive SCYX-7158

Drug: SCYX-7158

Placebo Comparator: Placebo of SCYX-7158

In each dose group (8 subjects) , 2 Healthy Volunteers receive placebo of SCYX-7158

Drug: Placebo

Outcome Measures

Primary Outcome Measures

Occurence of adverse events (AEs) [9 to 37 days, depending on the part of the study]
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).

Secondary Outcome Measures

Pharmacokinetic (blood concentration of SCYX-7158 and metabolite) [from pre-dose until 168 h post-dose.]
Pharmacokinetic (urine concentration of SCYX-7158 and metabolite) [from pre-dose until 168 h post-dose.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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.