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

Primary Purpose

Endometriosis

Status

Completed

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

BAY2328065

Placebo

About this trial

This is an interventional basic science trial for Endometriosis

Eligibility Criteria

18 Years - 50 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

CRS Clinical Research Services Berlin GmbH

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Verum

Placebo

Arm Description

Study group 1-11 of BAY2328065 (increasing dose levels for study group 2-11)

Study group 1-11 of Placebo

Outcomes

Primary Outcome Measures

Incidence of treatment-emergent adverse events

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

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

Secondary Outcome Measures

Full Information

NCT ID

NCT03427788

First Posted

February 5, 2018

Last Updated

February 19, 2019

Sponsor

Bayer

1. Study Identification

Unique Protocol Identification Number

NCT03427788

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Completed

Study Start Date

March 21, 2018 (Actual)

Primary Completion Date

October 29, 2018 (Actual)

Study Completion Date

February 11, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bayer

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Endometriosis

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

72 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Verum

Arm Type

Experimental

Arm Description

Study group 1-11 of BAY2328065 (increasing dose levels for study group 2-11)

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Study group 1-11 of Placebo

Intervention Type

Drug

Intervention Name(s)

BAY2328065

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Incidence of treatment-emergent adverse events

Description

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

Time Frame

Up to 8 days

Title

Severity of treatment-emergent adverse events

Description

Time Frame

Up to 8 days

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

CRS Clinical Research Services Berlin GmbH

City

Berlin

ZIP/Postal Code

13353

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

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

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