Trials / Completed
CompletedNCT02661178
First in Man Clinical Trial of Emodepside (BAY 44-4400)
A Phase 1, Blinded, Randomized, Placebo Controlled, Parallel-Group, Single-Dose, Dose-Escalation Study to Investigate Safety, Tolerability, and Pharmacokinetics of Emodepside (BAY 44-4400) After Oral Dosing in Healthy Male Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 79 (actual)
- Sponsor
- Drugs for Neglected Diseases · Academic / Other
- Sex
- Male
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | emodepside (BAY 44-4400) | |
| DRUG | placebo |
Timeline
- Start date
- 2015-12-01
- Primary completion
- 2017-03-27
- Completion
- 2017-03-27
- First posted
- 2016-01-22
- Last updated
- 2020-04-13
- Results posted
- 2020-04-13
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT02661178. Inclusion in this directory is not an endorsement.