check_circleStudy Completed

Endometriosis

Bayer Identifier:

19250

ClinicalTrials.gov Identifier:

NCT03427788

EudraCT Number:

2017-004056-38

EU CT Number:

Not Available
BAY2328065 Single dose escalation, safety and tolerability, pharmacokinetics, relative bioavailability, food effect

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

Key Participants Requirements

Sex

Male

Age

18 - 50 Years
  • - 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.
  • - 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
March 2018 - February 2019
Phase
Phase 1
Could I Receive a placebo
Yes
Products
BAY2328065
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
CRS Clinical Research Services Berlin GmbHBerlin, 13353, Germany

Primary Outcome

  • Incidence of treatment-emergent adverse events
    The frequency of adverse events collected from dosing until follow up, i.e. 8 days after dosing
    date_rangeTime Frame:
    Up to 8 days
  • Severity of treatment-emergent adverse events
    The 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 investigator
    date_rangeTime Frame:
    Up to 8 days

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

Additional Information

Click here to find further information and, after study completion, the study results according to Bayer's transparency standards.