Dose Proportionality Study With BAY94-8862 IR (Immediate Release) Tablets

January 27, 2022 updated by: Bayer

Single Center, Randomized, Open-label, 5-fold Crossover Study in Healthy Male Subjects to Investigate the Pharmacokinetic Dose Proportionality of BAY94-8862 Given as 5 Different Single Oral IR Tablet Doses (1.25, 2.5, 5.0, 7.5 and 10 mg)

This study should estimate the dose proportionality of BAY94-8862 IR tablets.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Nordrhein-Westfalen
      • Mönchengladbach, Nordrhein-Westfalen, Germany, 41061
        • CRS Clinical-Research-Services Mönchengladbach GmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 46 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Healthy male subject
  • Age: 18 to 46 years (inclusive) at the first screening examination
  • Ethnicity: White
  • Body mass index (BMI): >= 18 and <= 29.9 kg / m²

Exclusion Criteria:

  • Clinically relevant findings in the ECG (electrocardiogram) such as a second- or third-degree AV block, prolongation of the QRS complex over 120 msec
  • Systolic blood pressure below 100 or above 140 mmHg
  • Diastolic blood pressure below 50 or above 90 mmHg
  • Heart rate below 50 or above 95 beats/ min
  • Positive results for hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibodies (anti-HCV), human immune deficiency virus antibodies (anti-HIV 1+2)
  • Participation in another clinical study during the preceding 3 months (Last Treatment from previous study to First Treatment of new study)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BAY94-8862 (1.25mg)
single dose BAY94-8862 IR tablet 1.25mg
Drug: BAY94-8862 (1.25mg)
Experimental: BAY94-8862 (2.5mg)
single dose BAY94-8862 IR tablet 2.5mg
Drug: BAY94-8862 (2.5mg)
Experimental: BAY94-8862 (5mg)
single dose BAY94-8862 IR tablet 5mg
Drug: BAY94-8862 (5mg)
Experimental: BAY94-8862 (7.5mg)
single dose BAY94-8862 IR tablet 7.5mg
Drug: BAY94-8862 (7.5mg)
Experimental: BAY94-8862 (10mg)
single dose BAY94-8862 IR tablet 10mg
Drug: BAY94-8862 (10mg)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Dose proportionality of BAY94-8862 exposure in plasma when given as 1.25, 2.5, 5.0, 7.5 and 10 mg IR tablets
Time Frame: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 15, 24, 28 & 48 h
0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 15, 24, 28 & 48 h

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of participants with adverse events as a measure of safety and tolerability of BAY94-8862
Time Frame: Up to 48 h
Up to 48 h

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 17, 2012

Primary Completion (Actual)

November 28, 2012

Study Completion (Actual)

March 21, 2013

Study Registration Dates

First Submitted

September 14, 2012

First Submitted That Met QC Criteria

September 14, 2012

First Posted (Estimate)

September 19, 2012

Study Record Updates

Last Update Posted (Actual)

February 7, 2022

Last Update Submitted That Met QC Criteria

January 27, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15481
  • 2012-003055-10 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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