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

NCT01533961 Phase 1 COMPLETED

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.

Details

Lead sponsor	Drugs for Neglected Diseases
Phase	Phase 1
Status	COMPLETED
Enrolment	136
Start date	2012-02
Completion	2015-03

Conditions

• Trypanosomiasis
• Trypanosomiasis, African
• Protozoan Infections
• Parasitic Diseases

Interventions

• SCYX-7158
• Placebo

Primary outcomes

• 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).

Countries

France