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)

Resource links provided by NLM:


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
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
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014