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Safety, Tolerability and PK of Multiple-ascending Doses of Emodepside

NCT03383614 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2020-04-15

Study results available
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Summary

The study evaluates safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of emodepside, after administration as a Liquid Service Formulation (LSF), over 10 days, in healthy male caucasian subjects.

Conditions

  • Filariasis

Interventions

DRUG

LSF emodepside (BAY 44-4400) or matching placebo

Emodepside administered as an LSF oral solution (1mg/mL)

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • Drugs for Neglected Diseases

    lead OTHER

Principal Investigators

  • Jeremy Dennison, PhD MBChB · Hammersmith Medicines Research Limited

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-11-14
Primary Completion
2018-10-15
Completion
2018-10-15

Countries

  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03383614 on ClinicalTrials.gov