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

September 20, 2011
April 22, 2013
September 2011
December 2011   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01458028 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Age and Gender Effects on the Pharmacokinetics of BAY85-3934
A Parallel Group, Double-Blind Study to Evaluate the Effects of Age and Gender on the Single-Dose Pharmacokinetics of BAY85-3934, Tablet Formulation

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Anemia
  • Drug: BAY85-3934
    Single doses of 20 mg BAY85-3934 as tablet
  • Drug: Placebo
    Single dose of placebo tablet matching the 20 mg BAY85-3934 tablet
  • Experimental: Arm 1
    Intervention: Drug: BAY85-3934
  • Placebo Comparator: Arm 2
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
December 2011
December 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01458028
14631
No
Head Clinical Pharmacology, Bayer Healthcare Pharmaceuticals Inc.
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP