Clinical Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Pharmacodynamic Effects of a Single and Multiple Oral BAY1101042 Tablet Doses in Healthy Male Subjects

Single/Multiple Dose Escalation Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BAY1101042 Given as 5 mg MR Tablet After Single Oral Dosing Followed by Once Daily Dosing for 7 Days in 12 Healthy Male Subjects Per Dose Step in a Randomized, Placebo Controlled, Single Blind, Group Comparison Design

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03252002

Enrollment

Registered

2017-08-16

Start date

2017-08-16

Completion date

2019-07-24

Last updated

2019-08-19

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

Conditions

Healthy Volunteer

Keywords

Chronic kidney disease

Brief summary

To investigate the safety, tolerability, pharmacokinetics and effects of BAY1101042 in healthy male subjects after a single oral dose and multiple once daily dosing for 7 days

Interventions

DRUGBAY1101042

Single oral dose of 10 mg, 20 mg, 30 mg, 40 mg, 50 mg or optionally 5 mg BAY 1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days

DRUGPlacebo

Single dose on Day 1 (00d) and once daily for 7 days from Day 3 (02d) until Day 9 (08d)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* The informed consent must be signed before any study specific tests or procedures are done. * Healthy male subject. * Age: 18 to 45 years (inclusive) at the screening. * Body mass index (BMI): above/equal 18 and below/equal 29.9 kg/m2. * Ability to understand and follow study-related instructions.

Exclusion criteria

* Pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal. * Subjects with thyroid disorders as evidenced by assessment of thyroid stimulating hormone (TSH) levels outside the normal reference range at screening. * Regular use of medicines. * Smoking more than 10 cigarettes daily. * Systolic blood pressure below 100 or above 145 mmHg (at screening). * Diastolic blood pressure below 50 or above 90 mmHg (at screening). * Heart rate below 50 or above 90 beats/ min (at screening).

Design outcomes

Primary

Measure	Time frame	Description
Number of treatment emergent adverse events (TEAEs)	Approximately 19 days	Assessment of treatment emergent adverse events from first study drug intake until follow up

Secondary

Measure	Time frame	Description
AUC(0-24)/D of BAY1101042	At day 1	AUC(0-24)/D: dose-normalized area under the concentration vs. time curve from zero to 24 hours after single dose
Cmax of BAY1101042	At day 1	Cmax: maximum observed drug concentration after single dose
Cmax/D of BAY1101042	At day 1	Cmax/D: dose-normalized maximum observed drug concentration after single dose
AUC(0-24) of BAY1101042	At day 1	AUC(0-24): area under the concentration vs. time curve from zero to 24 hours after single dose
AUCτ,md/D of BAY1101042	At day 9	AUCτ,md/D: dose-normalized area under the concentration vs. time curve for the actual dosing interval after multiple dose
Cmax,md of BAY1101042	At day 9	Cmax,md: maximum observed drug concentration after multiple dose
Cmax,md/D of BAY1101042	At day 9	Cmax,md/D: dose-normalized maximum observed drug concentration after multiple dose
AUCτ,md of BAY1101042	At day 9	AUCτ,md: area under the concentration vs. time curve for the actual dosing interval after multiple dose

Countries

Germany

Outcome results

None listed

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