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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Drugs for Neglected Diseases.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Drugs for Neglected Diseases
ClinicalTrials.gov Identifier:
NCT01533961
First received: February 13, 2012
Last updated: February 15, 2012
Last verified: February 2012

February 13, 2012
February 15, 2012
February 2012
February 2013   (final data collection date for primary outcome measure)
Occurence of adverse events (AEs) [ Time Frame: 9 to 37 days, depending on the part of the study ] [ Designated as safety issue: Yes ]
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).
Same as current
Complete list of historical versions of study NCT01533961 on ClinicalTrials.gov Archive Site
  • Pharmacokinetic (blood concentration of SCYX-7158 and metabolite) [ Time Frame: from pre-dose until 168 h post-dose. ] [ Designated as safety issue: No ]
  • Pharmacokinetic (urine concentration of SCYX-7158 and metabolite) [ Time Frame: from pre-dose until 168 h post-dose. ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Human African Trypanosomiasis: First in Man Clinical Trial of a New Medicinal Product, the SCYX-7158
Randomized, Double-blind, Placebo-controlled Sequential Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SCYX-7158 After Single Oral Ascending Doses, Food Effect and Multiple Oral Ascending Dose 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.

The present study is designed to obtain safety, tolerability and PK data after single and multiple oral administration of increasing doses of SCYX-7158 in healthy male sub-Saharan African subjects. This study will also assess the impact of concomitant food intake on the relative bioavailability of SCYX-7158 administered as a capsule after single oral dose administration.

The study will be divided in 3 successive parts. Study Part I will be a randomized, double-blind, placebo-controlled, single ascending dose study with SCYX-7158 administered as a capsule.

Study Part II will be a comparative bioavailability study of SCYX-7158 capsule administered in fasting or fed condition (assessment of food effect), according to a two-way cross-over design (or three ways depending on results). Clinical part will be conducted in open conditions and bioanalysis in blind conditions.

Study Part III will be a randomized, double-blind, placebo-controlled, multiple ascending dose study with SCYX-7158 administered as a capsule. Dosage regimen will be either q.d. or b.i.d., depending on Part I and Part II results for the unchanged drug and the metabolite. Treatment duration will be 15 days, including placebo on day-1.

Bioanalysis will be performed in open conditions for Study Part I and Study Part III.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Trypanosomiasis
  • Trypanosomiasis, African
  • Protozoan Infections
  • Parasitic Diseases
  • Drug: SCYX-7158
  • Drug: Placebo
  • Experimental: SCYX-7158
    Intervention: Drug: SCYX-7158
  • Placebo Comparator: Placebo of SCYX-7158
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
February 2013
February 2013   (final data collection date for primary outcome measure)

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.
Male
18 Years to 45 Years
Yes
Contact: Antoine Tarral, MD atarral@dndi.org
Contact: Séverine Blesson, MSc sblesson@dndi.org
France
 
NCT01533961
DNDiOXA001, 2011-004639-30
No
Drugs for Neglected Diseases
Drugs for Neglected Diseases
Not Provided
Study Director: Antoine Tarral, MD Drugs for Neglected Diseases initiative
Drugs for Neglected Diseases
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP