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

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

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

Study Overview

• Status: Completed
• Conditions: Endometriosis
• Intervention / Treatment: Drug: BAY2328065; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 13353
    • CRS Clinical Research Services Berlin GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Verum; Study group 1-11 of BAY2328065 (increasing dose levels for study group 2-11)	Drug: BAY2328065; Doses from 2.25-700 mg once daily in an escalating manner as liquid service formulation (LSF) or tablets
Placebo Comparator: Placebo; Study group 1-11 of Placebo	Drug: Placebo; Matching placebo, once daily in an escalating manner as LSF or tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2018
• Primary Completion (Actual): October 29, 2018
• Study Completion (Actual): February 11, 2019

Study Registration Dates

• First Submitted: February 5, 2018
• First Submitted That Met QC Criteria: February 5, 2018
• First Posted (Actual): February 9, 2018

Study Record Updates

• Last Update Posted (Actual): February 29, 2024
• Last Update Submitted That Met QC Criteria: February 28, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Endometriosis
• Other Study ID Numbers: 19250; 2017-004056-38 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No