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BAY 1902607: Single Dose Escalation, Safety and Tolerability, Pharmacokinetics, Bioavailability, Food Effect

NCT ID: NCT03212586

Last Updated: 2019-05-14

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

2017-07-18

Study Completion Date

2018-07-27

Brief Summary

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This study is a first-in-man study that will investigate the safety, tolerability and pharmacokinetics of ascending single doses of BAY1902607 using a placebo controlled, randomized, single center design. In addition the influence of food on the pharmacokinetics of BAY1902607 and the bioavailability between different pharmaceutical formulations will be investigated

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Detailed Description

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Conditions

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Clinical Trials, Phase I as Topic

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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Dose escalation BAY1902607

Dose 1 to 9 of BAY1902607

Group Type EXPERIMENTAL

BAY1902607

Intervention Type DRUG

Escalating doses of BAY1902607; single dose administration; different dosage forms (redosing of BAY1902607 at dose group 4 with different formulations; redosing of BAY1902607 solid formulation at dose group 4 together with food)

Dose escalation Placebo

Dose 1 to 9 of matching placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Escalating doses of Placebo; single dose administration; different dosage forms (redosing of Placebo at dose group 4 with different formulations; redosing of Placebo solid formulation at dose group 4 together with food)

Interventions

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BAY1902607

Escalating doses of BAY1902607; single dose administration; different dosage forms (redosing of BAY1902607 at dose group 4 with different formulations; redosing of BAY1902607 solid formulation at dose group 4 together with food)

Intervention Type DRUG

Placebo

Escalating doses of Placebo; single dose administration; different dosage forms (redosing of Placebo at dose group 4 with different formulations; redosing of Placebo solid formulation at dose group 4 together with food)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male subjects.
* Age: 18 to 45 years (inclusive) .
* Body mass index (BMI) : ≥18 and ≤30 kg/m\^2.
* Race: White.

Exclusion Criteria

* Any findings from the medical examination (including medical history, physical examination, vital signs, laboratory tests and ECG) deviating from normal and deemed by the investigator to be of clinical relevance.
* Relevant diseases within the 4 weeks before the first drug administration.
* Febrile illness within the week before the first taste test is conducted.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 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://www.clinicaltrialsregister.eu/

Click here to find information about studies related to Bayer Healthcare products conducted in Europe.

Other Identifiers

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2017-000978-11

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

18922

Identifier Type: -

Identifier Source: org_study_id

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