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Age and Gender Effects on the Pharmacokinetics of BAY85-3934

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01458028
First received: September 20, 2011
Last updated: April 22, 2013
Last verified: April 2013
History of Changes
  Purpose

Single dose study of BAY85-3934 compared to placebo in young/elderly male and female healthy subjects. The main focus of the study is to determine if the pharmacokinetics (drug levels in blood) of BAY85-3934 is similar or not in the four subject groups. Qualifying subjects will be dosed with a single tablet of BAY85-3934 (or placebo) and blood will be drawn over 4 days. The safety and tolerability of BAY85-3934 compared to placebo will also be evaluated over the 5 days of the study.


Condition Intervention Phase
Anemia
 Drug: BAY85-3934
Drug: Placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: A Parallel Group, Double-Blind Study to Evaluate the Effects of Age and Gender on the Single-Dose Pharmacokinetics of BAY85-3934, Tablet Formulation

Resource links provided by NLM:

MedlinePlus related topics: Anemia
U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Area under the plasma concentration vs time curve from zero to infinity after single (first) dose of BAY85-3934 [ Time Frame: Measured over 72 hours after dosing ] [ Designated as safety issue: No ]
  • Maximum drug concentration in plasma after single dose administration of BAY85-3934 [ Time Frame: Measured over 72 hours after dosing ] [ Designated as safety issue: No ]
  • Safety and tolerability of BAY 85-3934 after single dose administration as determined by physical examination (changes from baseline) [ Time Frame: Measured over 96 hours after dosing ] [ Designated as safety issue: Yes ]
  • Safety and tolerability of BAY 85-3934 after single dose administration as determined by adverse events monitoring (number of subjects with a specific event) [ Time Frame: Measured over 96 hours after dosing ] [ Designated as safety issue: Yes ]
  • Safety and tolerability of BAY 85-3934 after single dose administration as determined by electrocardigram and and vital sign measurememnt (changes from baseline) [ Time Frame: Measured over 72 hours after dosing ] [ Designated as safety issue: Yes ]
  • Safety and tolerability of BAY 85-3934 after single dose administration as determined by laboratory testing (changes from baseline) [ Time Frame: Measured over 48 hours after dosing ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacodynamic effects on erythropoietin as the change from baseline at 48 hours [ Time Frame: 48 hours post dose ] [ Designated as safety issue: No ]
  • Pharmacodynamic effects on reticulocytes as the change from baseline at 96 hours [ Time Frame: 96 hours post dose ] [ Designated as safety issue: No ]
  • Pharmacodynamic effects on hemoglobin as the change from baseline at 48 hours [ Time Frame: 48 hours post dose ] [ Designated as safety issue: No ]
  • Pharmacodynamic effects on hematocrit as the change from baseline at 96 hours [ Time Frame: 96 hours post dose ] [ Designated as safety issue: No ]
  • Pharmacodynamic effects on vascular endothelial growth factor (VEGF) as the change from baseline at 96 hours [ Time Frame: 96 hours post dose ] [ Designated as safety issue: No ]

Enrollment: 48
Study Start Date: September 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: BAY85-3934
Single doses of 20 mg BAY85-3934 as tablet
Placebo Comparator: Arm 2 Drug: Placebo
Single dose of placebo tablet matching the 20 mg BAY85-3934 tablet

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • No diagnosis of any specific disease or condition
  • Subjects are expected to be in good general health for their respective age range
  • Male or female gender
  • Age subgroups: 1) 18 to 45 years (inclusive) and 2) 65 to 85 years (inclusive)
  • Racial group: Caucasian

Exclusion Criteria:

  • 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. This includes moderate and severe renal impairment (on dialysis or not), and moderate or severe hepatic disease.
  • Clinically relevant findings in the physical examination
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01458028

Locations
United States, North Dakota
Fargo, North Dakota, United States, 58104
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Head Clinical Pharmacology, Bayer Healthcare Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT01458028     History of Changes
Other Study ID Numbers: 14631
Study First Received: September 20, 2011
Last Updated: April 22, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Bayer:
BAY85-3934
pharmacokinetics
age
gender

Additional relevant MeSH terms:
Anemia
Hematologic Diseases

ClinicalTrials.gov processed this record on June 17, 2013