check_circleStudy 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

  • - 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

  • - 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
48
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

StatusInstitutionLocation
Completed
Cetero ResearchFargo, 58104, United States

Primary Outcome

  • Area under the plasma concentration vs time curve from zero to infinity after single (first) dose of BAY85-3934
    date_rangeTime Frame:
    Measured over 72 hours after dosing
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    Safety Issue:
    No
  • Maximum drug concentration in plasma after single dose administration of BAY85-3934
    date_rangeTime Frame:
    Measured over 72 hours after dosing
    enhanced_encryption
    Safety Issue:
    No
  • Safety and tolerability of BAY 85-3934 after single dose administration as determined by physical examination (changes from baseline)
    date_rangeTime Frame:
    Measured over 96 hours after dosing
    enhanced_encryption
    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)
    date_rangeTime Frame:
    Measured over 96 hours after dosing
    enhanced_encryption
    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)
    date_rangeTime Frame:
    Measured over 72 hours after dosing
    enhanced_encryption
    Safety Issue:
    Yes
  • Safety and tolerability of BAY 85-3934 after single dose administration as determined by laboratory testing (changes from baseline)
    date_rangeTime Frame:
    Measured over 48 hours after dosing
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • Pharmacodynamic effects on erythropoietin as the change from baseline at 48 hours
    date_rangeTime Frame:
    48 hours post dose
    enhanced_encryption
    Safety Issue:
    No
  • Pharmacodynamic effects on reticulocytes as the change from baseline at 96 hours
    date_rangeTime Frame:
    96 hours post dose
    enhanced_encryption
    Safety Issue:
    No
  • Pharmacodynamic effects on hemoglobin as the change from baseline at 48 hours
    date_rangeTime Frame:
    48 hours post dose
    enhanced_encryption
    Safety Issue:
    No
  • Pharmacodynamic effects on hematocrit as the change from baseline at 96 hours
    date_rangeTime Frame:
    96 hours post dose
    enhanced_encryption
    Safety Issue:
    No
  • Pharmacodynamic effects on vascular endothelial growth factor (VEGF) as the change from baseline at 96 hours
    date_rangeTime Frame:
    96 hours post dose
    enhanced_encryption
    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
2

Additional Information

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