Age and Gender Effects on the Pharmacokinetics of BAY85-3934

Phase 1

Completed

• Conditions: Anemia
• Interventions: Drug: BAY85-3934; Drug: Placebo

• Registration Number: NCT01458028
• Lead Sponsor: Bayer

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-09-20
• Study First Submitted QC: 2011-10-21
• Study First Posted: 2011-10-24
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-05
• Last Update Posted: 2014-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	BAY85-3934	-
Arm 2	Placebo	-

Primary Outcome Measures

Name	Time	Method
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
Maximum drug concentration in plasma after single dose administration of BAY85-3934	Measured over 72 hours after dosing
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
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
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
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

Secondary Outcome Measures

Name	Time	Method
Pharmacodynamic effects on erythropoietin as the change from baseline at 48 hours	48 hours post dose
Pharmacodynamic effects on reticulocytes as the change from baseline at 96 hours	96 hours post dose
Pharmacodynamic effects on hemoglobin as the change from baseline at 48 hours	48 hours post dose
Pharmacodynamic effects on hematocrit as the change from baseline at 96 hours	96 hours post dose
Pharmacodynamic effects on vascular endothelial growth factor (VEGF) as the change from baseline at 96 hours	96 hours post dose