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

Bayer72 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Enrollment

Conditions

Endometriosis

Interventions

BAY2328065DRUG

Doses from 2.25-700 mg once daily in an escalating manner as liquid service formulation (LSF) or tablets

PlaceboDRUG

Matching placebo, once daily in an escalating manner as LSF or tablets

Eligibility

Sex: MALEMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

CRS Clinical Research Services Berlin GmbH

Berlin, Germany

Outcomes

Primary Outcomes

Incidence of treatment-emergent adverse events

The frequency of adverse events collected from dosing until follow up, i.e. 8 days after dosing

Time 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: 1. Results in death 2. Is life-threatening 3. Requires inpatient hospitalization or prolongation of existing hospitalization 4. Results in persistent or significant disability / incapacity 5. Is a congenital anomaly / birth defect 6. Is another serious or important medical event as judged by the investigator

Time frame: Up to 8 days

Data from ClinicalTrials.gov

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