NCT01533961

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
136

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Feb 2012

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

February 13, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 16, 2012

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

September 18, 2015

Status Verified

February 1, 2012

Enrollment Period

3.1 years

First QC Date

February 13, 2012

Last Update Submit

September 17, 2015

Conditions

TrypanosomiasisTrypanosomiasis, AfricanProtozoan InfectionsParasitic Diseases

Keywords

neglected diseaseafricanew drugoral drugparasite

Outcome Measures

Primary Outcomes (1)

  • Occurence of adverse events (AEs)

    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).

    9 to 37 days, depending on the part of the study

Secondary Outcomes (2)

  • 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.

Study Arms (2)

SCYX-7158

EXPERIMENTAL

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

Drug: SCYX-7158

Placebo of SCYX-7158

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

SCYX-7158DRUG
SCYX-7158
PlaceboDRUG
Placebo of SCYX-7158

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

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,
  • 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 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,
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Optimed

Grenoble, France

Location

SGS Aster

Paris, France

Location

Related Publications (1)

  • Tarral A, Hovsepian L, Duvauchelle T, Donazzolo Y, Latreille M, Felices M, Gualano V, Delhomme S, Valverde Mordt O, Blesson S, Voiriot P, Strub-Wourgaft N. Determination of the Optimal Single Dose Treatment for Acoziborole, a Novel Drug for the Treatment of Human African Trypanosomiasis: First-in-Human Study. Clin Pharmacokinet. 2023 Mar;62(3):481-491. doi: 10.1007/s40262-023-01216-8. Epub 2023 Feb 10.

    PMID: 36763327DERIVED

Related Links

MeSH Terms

Conditions

TrypanosomiasisTrypanosomiasis, AfricanProtozoan InfectionsParasitic DiseasesNeglected Diseases

Interventions

SCYX 7158

Condition Hierarchy (Ancestors)

Euglenozoa InfectionsInfectionsVector Borne DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Antoine Tarral, MD

    Drugs for Neglected Diseases initiative

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2012

First Posted

February 16, 2012

Study Start

February 1, 2012

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

September 18, 2015

Record last verified: 2012-02

Locations

FR(2)