Clinical trial NCT01458028: Age and Gender Effects on the Pharmacokinetics of BAY85-3934
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Anemia
Keywords: BAY85-3934
pharmacokinetics
age
gender
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2011-10-24
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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

Primary outcomes:
measure: Area under the plasma concentration vs time curve from zero to infinity after single (first) dose of BAY85-3934
timeFrame: Measured over 72 hours after dosing
measure: Maximum drug concentration in plasma after single dose administration of BAY85-3934
timeFrame: Measured over 72 hours after dosing
measure: Safety and tolerability of BAY 85-3934 after single dose administration as determined by physical examination (changes from baseline)
timeFrame: Measured over 96 hours after dosing
measure: Safety and tolerability of BAY 85-3934 after single dose administration as determined by adverse events monitoring (number of subjects with a specific event)
timeFrame: Measured over 96 hours after dosing
measure: Safety and tolerability of BAY 85-3934 after single dose administration as determined by electrocardigram and and vital sign measurememnt (changes from baseline)
timeFrame: Measured over 72 hours after dosing
measure: Safety and tolerability of BAY 85-3934 after single dose administration as determined by laboratory testing (changes from baseline)
timeFrame: Measured over 48 hours after dosing
Secondary outcomes:
measure: Pharmacodynamic effects on erythropoietin as the change from baseline at 48 hours
timeFrame: 48 hours post dose
measure: Pharmacodynamic effects on reticulocytes as the change from baseline at 96 hours
timeFrame: 96 hours post dose
measure: Pharmacodynamic effects on hemoglobin as the change from baseline at 48 hours
timeFrame: 48 hours post dose
measure: Pharmacodynamic effects on hematocrit as the change from baseline at 96 hours
timeFrame: 96 hours post dose
measure: Pharmacodynamic effects on vascular endothelial growth factor (VEGF) as the change from baseline at 96 hours
timeFrame: 96 hours post dose
Other outcomes:
Locations:
city: Fargo
country: United States
state: North Dakota
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: