Trial Condition(s):
Endometriosis
BAY2328065 Single dose escalation, safety and tolerability, pharmacokinetics, relative bioavailability, food effect
Bayer Identifier:
19250
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations CRS Clinical Research Services Berlin GmbH Berlin, Germany, 13353 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Trial Design
Randomized, placebo-controlled, double-blind, parallel group study to investigate the safety, tolerability and pharmacokinetics of increasing single oral doses of BAY2328065 including the relative bioavailability between solution and tablet formulation and the effect of food on the pharmacokinetics of BAY2328065 in healthy men
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Basic Science
Allocation:
Randomized
Blinding:
N/A
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Incidence of treatment-emergent adverse eventsThe frequency of adverse events collected from dosing until follow up, i.e. 8 days after dosingTimeframe: Up to 8 days
- Severity of treatment-emergent adverse eventsThe severity of adverse events collected from dosing until follow up, i.e. 8 days after dosing Severity is assessed by the following criteria: a. Results in death b. Is life-threatening c. Requires inpatient hospitalization or prolongation of existing hospitalization d. Results in persistent or significant disability / incapacity e. Is a congenital anomaly / birth defect f. Is another serious or important medical event as judged by the investigatorTimeframe: Up to 8 days
Additional Information
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