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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01687920
First Posted: September 19, 2012
Last Update Posted: January 10, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Bayer
  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
Intervention Model: Crossover Assignment
Masking: None (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 ]

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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 46 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01687920


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

Additional Information:
Responsible Party: Head of Clinical Sciences, Bayer Healthcare AG
ClinicalTrials.gov Identifier: NCT01687920     History of Changes
Other Study ID Numbers: 15481
2012-003055-10 ( EudraCT Number )
First Submitted: September 14, 2012
First Posted: September 19, 2012
Last Update Posted: January 10, 2014
Last Verified: January 2014

Keywords provided by Bayer:
Cardiac disorders

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases