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

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01687920
First received: September 14, 2012
Last updated: January 8, 2014
Last verified: January 2014
  Purpose

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


Condition Intervention Phase
Heart Failure
Drug: BAY94-8862 (1.25mg)
Drug: BAY94-8862 (2.5mg)
Drug: BAY94-8862 (5mg)
Drug: BAY94-8862 (7.5mg)
Drug: BAY94-8862 (10mg)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: 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)

Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of participants with adverse events as a measure of safety and tolerability of BAY94-8862 [ Time Frame: Up to 48 h ] [ Designated as safety issue: Yes ]

Enrollment: 25
Study Start Date: September 2012
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years to 46 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01687920

Locations
Germany
Mönchengladbach, Nordrhein-Westfalen, Germany, 41061
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Head of Clinical Sciences, Bayer Healthcare AG
ClinicalTrials.gov Identifier: NCT01687920     History of Changes
Other Study ID Numbers: 15481, 2012-003055-10
Study First Received: September 14, 2012
Last Updated: January 8, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Bayer:
Cardiac disorders

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on October 21, 2014