Study Completed

Anemia

Bayer Identifier:

14631

ClinicalTrials.gov Identifier:

NCT01458028

EudraCT Number:

Not Available

EU CT Number:

Not Available

Age and Gender Effects on the Pharmacokinetics of BAY85-3934

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

18 - 85 Years

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

Trial summary

Enrollment Goal

Trial Dates

September 2011 - December 2011

Phase

Phase 1

Could I Receive a placebo

Yes

Products

Molidustat (BAY85-3934)

Accepts Healthy Volunteer

Yes

Where to participate

Status	Institution	Location
Completed	Cetero Research	Fargo, 58104, United States

Primary Outcome

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
Safety Issue:
No
Maximum drug concentration in plasma after single dose administration of BAY85-3934
Time Frame:
Measured over 72 hours after dosing
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
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
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
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
Safety Issue:
Yes

Secondary Outcome

Pharmacodynamic effects on erythropoietin as the change from baseline at 48 hours
Time Frame:
48 hours post dose
Safety Issue:
No
Pharmacodynamic effects on reticulocytes as the change from baseline at 96 hours
Time Frame:
96 hours post dose
Safety Issue:
No
Pharmacodynamic effects on hemoglobin as the change from baseline at 48 hours
Time Frame:
48 hours post dose
Safety Issue:
No
Pharmacodynamic effects on hematocrit as the change from baseline at 96 hours
Time Frame:
96 hours post dose
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
Safety Issue:
No

Trial design

A Parallel Group, Double-Blind Study to Evaluate the Effects of Age and Gender on the Single-Dose Pharmacokinetics of BAY85-3934, Tablet Formulation

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Basic Science

Allocation

Randomized

Blinding

Double Blind

Assignment

Parallel Assignment

Trial Arms

Additional Information

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