Age and Gender Effects on the Pharmacokinetics of BAY85-3934

Anemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01458028
• Other study ID #: 14631
• Status: Completed
• Phase: Phase 1
• First received: September 20, 2011
• Last updated: May 5, 2014
• Start date: September 2011
• Est. completion date: December 2011

Study information

• Verified date: May 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Anemia

Intervention

Drug:
• BAY85-3934
Single doses of 20 mg BAY85-3934 as tablet
• Placebo
Single dose of placebo tablet matching the 20 mg BAY85-3934 tablet

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the plasma concentration vs time curve from zero to infinity after single (first) dose of BAY85-3934		Measured over 72 hours after dosing	No
Primary	Maximum drug concentration in plasma after single dose administration of BAY85-3934		Measured over 72 hours after dosing	No
Primary	Safety and tolerability of BAY 85-3934 after single dose administration as determined by physical examination (changes from baseline)		Measured over 96 hours after dosing	Yes
Primary	Safety and tolerability of BAY 85-3934 after single dose administration as determined by adverse events monitoring (number of subjects with a specific event)		Measured over 96 hours after dosing	Yes
Primary	Safety and tolerability of BAY 85-3934 after single dose administration as determined by electrocardigram and and vital sign measurememnt (changes from baseline)		Measured over 72 hours after dosing	Yes
Primary	Safety and tolerability of BAY 85-3934 after single dose administration as determined by laboratory testing (changes from baseline)		Measured over 48 hours after dosing	Yes
Secondary	Pharmacodynamic effects on erythropoietin as the change from baseline at 48 hours		48 hours post dose	No
Secondary	Pharmacodynamic effects on reticulocytes as the change from baseline at 96 hours		96 hours post dose	No
Secondary	Pharmacodynamic effects on hemoglobin as the change from baseline at 48 hours		48 hours post dose	No
Secondary	Pharmacodynamic effects on hematocrit as the change from baseline at 96 hours		96 hours post dose	No
Secondary	Pharmacodynamic effects on vascular endothelial growth factor (VEGF) as the change from baseline at 96 hours		96 hours post dose	No

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