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BAY 1902607: Single Dose Escalation, Safety and Tolerability, Pharmacokinetics, Bioavailability, Food Effect | Clinical Trials | Clareo Health

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

Randomized, Placebo-controlled, Double-blind, Parallel-group Study to Investigate the Safety, Tolerability and Pharmacokinetics of Increasing Single Oral Doses of BAY1902607 Including the Relative Bioavailability Between Different Pharmaceutical Formulations and the Effect of Food on the Pharmacokinetics of BAY1902607 in Healthy Men

NCT03212586•Bayer

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - 45 years

Sex

MALE

Healthy Volunteers

Yes

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.

Locations (1)

CRS Clinical Research Services Berlin GmbH

Berlin, Germany

Key Dates

Start Date

July 18, 2017

Primary Completion Date

May 3, 2018

Completion Date

July 27, 2018

Last Updated

May 14, 2019

Enrollment

ACTUAL participants

Conditions

Clinical Trials, Phase I as Topic

Interventions

BAY1902607

DRUG

Placebo

DRUG