BAY2328065 Single Dose Escalation, Safety and Tolerability, Pharmacokinetics, Relative Bioavailability, Food Effect

Endometriosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03427788
• Other study ID #: 19250
• Secondary ID: 2017-004056-38
• Status: Completed
• Phase: Phase 1
• Start date: March 21, 2018
• Est. completion date: February 11, 2019

Study information

• Verified date: February 2024
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 doses of BAY2328065

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: February 11, 2019
• Est. primary completion date: October 29, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Endometriosis

Intervention

Drug:
• BAY2328065
Doses from 2.25-700 mg once daily in an escalating manner as liquid service formulation (LSF) or tablets
• Placebo
Matching placebo, once daily in an escalating manner as LSF or tablets

Locations

Country	Name	City	State
Germany	CRS Clinical Research Services Berlin GmbH	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of treatment-emergent adverse events	The frequency of adverse events collected from dosing until follow up, i.e. 8 days after dosing	Up to 8 days
Primary	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: Results in death; Is life-threatening; Requires inpatient hospitalization or prolongation of existing hospitalization; Results in persistent or significant disability / incapacity; Is a congenital anomaly / birth defect; Is another serious or important medical event as judged by the investigator	Up to 8 days

External Links

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