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First in Man Clinical Trial of Emodepside (BAY 44-4400)

NCT02661178 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 79

Last updated 2020-04-13

Study results available
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Summary

This study will investigate the safety, tolerability, and pharmacokinetics of single ascending doses of emodepside (BAY 44-4400) in healthy male volunteers. This study will also conduct an exploratory investigation of the relative bioavailability of emodepside administered as tablets and determine the effect of food on the pharmacokinetics.

Conditions

  • Healthy Volunteers

Interventions

DRUG

emodepside (BAY 44-4400)

DRUG

placebo

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • Drugs for Neglected Diseases

    lead OTHER

Principal Investigators

  • Malcolm Boyce, MD, BSc · Hammersmith Medicines Research

  • Frederic Monnot · Drugs for Neglected Diseases initiative

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2017-03-27
Completion
2017-03-27

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
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 NCT02661178 on ClinicalTrials.gov