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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03427788

Enrollment

Registered

2018-02-09

Start date

2018-03-21

Completion date

2019-02-11

Last updated

2024-02-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometriosis

Brief 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

Interventions

DRUGBAY2328065

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

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

18 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Incidence of treatment-emergent adverse events	Up to 8 days	The frequency of adverse events collected from dosing until follow up, i.e. 8 days after dosing
Severity of treatment-emergent adverse events	Up to 8 days	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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026