Status:
COMPLETED
BAY2328065 Single Dose Escalation, Safety and Tolerability, Pharmacokinetics, Relative Bioavailability, Food Effect
Lead Sponsor:
Bayer
Conditions:
Endometriosis
Eligibility:
MALE
18-50 years
Phase:
PHASE1
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 21 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 11 2019
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT03427788
Start Date
March 21 2018
End Date
February 11 2019
Last Update
February 29 2024
Active Locations (1)
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1
CRS Clinical Research Services Berlin GmbH
Berlin, Germany, 13353