Trial Condition(s):

Endometriosis

BAY2328065 Single dose escalation, safety and tolerability, pharmacokinetics, relative bioavailability, food effect

Bayer Identifier:

19250

ClinicalTrials.gov Identifier:

NCT03427788

EudraCT Number:

2017-004056-38

Study Completed

Trial Purpose

This single center, double-blind, randomized study with up to 11 treatment groups evaluates the safety and tolerability, pharmacokinetics, relative bioavailability and food effect of single ascending doses of BAY2328065

Inclusion Criteria
- Healthy male volunteers, aged 18 - 45 years
- Body mass index (BMI): 18 ≤ BMI ≤ 30 kg/m²
- Smoking less than 10 cigarettes / day
- Signed informed consent
- Use of an accepted method of contraception for the duration of the study.
Exclusion Criteria
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders, thyroid disorders or malignant tumors
- Known severe allergies, non allergic drug reactions, or multiple drug allergies
- Medication history: any regular medication, esp. drugs known to induce/inhibit liver enzymes or transporters
- Clinically relevant findings in physical examination; ECG, blood pressure; laboratory values

Trial Summary

Enrollment Goal
72
Trial Dates
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Phase
1
Could I receive a placebo?
Yes
Products
BAY2328065
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

CRS Clinical Research Services Berlin GmbH

Berlin, Germany, 13353

Status
Completed
 

Trial Design