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NCT Number: NCT01458028

Age and Gender Effects on the Pharmacokinetics of BAY85-3934

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.

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Key information

Conditions

Anemia Behavior Coitus Hematologic Diseases Hemic and Lymphatic Diseases Sexual Behavior

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Fargo, North Dakota, 58104, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BAY85-3934

Drug

Single doses of 20 mg BAY85-3934 as tablet

Placebo

Drug

Single dose of placebo tablet matching the 20 mg BAY85-3934 tablet

Primary outcomes

  1. 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

  2. Maximum drug concentration in plasma after single dose administration of BAY85-3934

    Time frame: Measured over 72 hours after dosing

  3. 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

  4. 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

  5. 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

  6. 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

Secondary outcomes

  1. Pharmacodynamic effects on erythropoietin as the change from baseline at 48 hours

    Time frame: 48 hours post dose

  2. Pharmacodynamic effects on reticulocytes as the change from baseline at 96 hours

    Time frame: 96 hours post dose

  3. Pharmacodynamic effects on hemoglobin as the change from baseline at 48 hours

    Time frame: 48 hours post dose

  4. Pharmacodynamic effects on hematocrit as the change from baseline at 96 hours

    Time frame: 96 hours post dose

  5. Pharmacodynamic effects on vascular endothelial growth factor (VEGF) as the change from baseline at 96 hours

    Time frame: 96 hours post dose

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Oct 24, 2011
Registry last updated
May 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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