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

NCT03252002 | Completed Phase 1

• 2 other identifiers: 187472017-001212-11
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 2

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

Conditions

Healthy Volunteer

Keywords

Chronic kidney disease

Outcome Measures

Primary Outcomes (1)

• Number of treatment emergent adverse events (TEAEs)

  Assessment of treatment emergent adverse events from first study drug intake until follow up

  Approximately 19 days

Secondary Outcomes (8)

• AUC(0-24) of BAY1101042

  At day 1

• AUC(0-24)/D of BAY1101042

  At day 1

• Cmax of BAY1101042

  At day 1

• Cmax/D of BAY1101042

  At day 1

• AUCτ,md of BAY1101042

  At day 9

Study Arms (6)

Single/multiple doses of 10 mg BAY1101042 or placebo

EXPERIMENTAL

Single oral dose of 10 mg BAY1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days

Drug: BAY1101042; Drug: Placebo

Single/ multiple doses of 20 mg BAY1101042 or placebo

EXPERIMENTAL

Single oral dose of 20 mg BAY1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days

Drug: BAY1101042; Drug: Placebo

Single/ multiple doses of 30 mg BAY1101042 or placebo

EXPERIMENTAL

Single oral dose of 30 mg BAY1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days

Drug: BAY1101042; Drug: Placebo

Single/ multiple doses of 40 mg BAY1101042 or placebo

EXPERIMENTAL

Single oral dose of 40 mg BAY1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days

Drug: BAY1101042; Drug: Placebo

Single/ multiple doses of 50 mg BAY1101042 or placebo

EXPERIMENTAL

Single oral dose of 50 mg BAY1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days

Drug: BAY1101042; Drug: Placebo

Optional: Single/multiple doses of 5 mg BAY 1101042 or placebo

EXPERIMENTAL

Single oral dose of 5 mg BAY1101042 MR tablets or corresponding placebo followed by once daily dosing for 7 days

Drug: BAY1101042; Drug: Placebo

Interventions

BAY1101042 DRUG

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

Optional: Single/multiple doses of 5 mg BAY 1101042 or placebo; Single/ multiple doses of 20 mg BAY1101042 or placebo; Single/ multiple doses of 30 mg BAY1101042 or placebo; Single/ multiple doses of 40 mg BAY1101042 or placebo; Single/ multiple doses of 50 mg BAY1101042 or placebo; Single/multiple doses of 10 mg BAY1101042 or placebo

Placebo DRUG

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

Optional: Single/multiple doses of 5 mg BAY 1101042 or placebo; Single/ multiple doses of 20 mg BAY1101042 or placebo; Single/ multiple doses of 30 mg BAY1101042 or placebo; Single/ multiple doses of 40 mg BAY1101042 or placebo; Single/ multiple doses of 50 mg BAY1101042 or placebo; Single/multiple doses of 10 mg BAY1101042 or placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Bayer: lead

Study Sites (2)

CRS Clinical-Research-Services Mönchengladbach GmbH

Mönchengladbach, North Rhine-Westphalia, 41061, Germany

Location

CRS Clinical Research Services Wuppertal GmbH

Wuppertal, North Rhine-Westphalia, 42113, Germany

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2017
• First Posted: August 16, 2017
• Study Start: August 16, 2017
• Primary Completion: April 30, 2019
• Study Completion: July 24, 2019
• Last Updated: August 19, 2019

Record last verified: 2019-08

Locations

DE (2)