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
  Purpose

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 Intervention Phase
Trypanosomiasis
Trypanosomiasis, African
Protozoan Infections
Parasitic Diseases
Drug: SCYX-7158
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Masking: Double Blind (Subject, Caregiver, 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, Food Effect and Multiple Oral Ascending Dose in Healthy Male Volunteers

Resource links provided by NLM:


Further study details as provided by Drugs for Neglected Diseases:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 120
Study Start Date: February 2012
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SCYX-7158 Drug: SCYX-7158
Placebo Comparator: Placebo of SCYX-7158 Drug: Placebo

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01533961

Contacts
Contact: Antoine Tarral, MD atarral@dndi.org
Contact: Séverine Blesson, MSc sblesson@dndi.org

Locations
France
SGS Aster Recruiting
Paris, France
Contact: Lionel Hovsepian, MD         
Principal Investigator: Lionel Hovsepian, MD         
Sponsors and Collaborators
Drugs for Neglected Diseases
Investigators
Study Director: Antoine Tarral, MD Drugs for Neglected Diseases initiative
  More Information

Additional Information:
No publications provided

Responsible Party: Drugs for Neglected Diseases
ClinicalTrials.gov Identifier: NCT01533961     History of Changes
Other Study ID Numbers: DNDiOXA001, 2011-004639-30
Study First Received: February 13, 2012
Last Updated: February 15, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Drugs for Neglected Diseases:
neglected disease
africa
new drug
oral drug
parasite

Additional relevant MeSH terms:
Parasitic Diseases
Protozoan Infections
Trypanosomiasis
Trypanosomiasis, African
Euglenozoa Infections

ClinicalTrials.gov processed this record on April 21, 2014