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

NCT ID: NCT03427788

Last Updated: 2024-02-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-21

Study Completion Date

2019-02-11

Brief Summary

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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

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Detailed Description

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Conditions

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Endometriosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Verum

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

Group Type EXPERIMENTAL

BAY2328065

Intervention Type DRUG

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

Placebo

Study group 1-11 of Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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BAY2328065

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CRS Clinical Research Services Berlin GmbH

Berlin, , Germany

Site Status

Countries

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Germany

Related Links

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http://clinicaltrials.bayer.com/study/19250

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

Other Identifiers

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2017-004056-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

19250

Identifier Type: -

Identifier Source: org_study_id

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