Status:
COMPLETED
Age and Gender Effects on the Pharmacokinetics of BAY85-3934
Lead Sponsor:
Bayer
Conditions:
Anemia
Eligibility:
All Genders
18-85 years
Phase:
PHASE1
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 BAY...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT01458028
Start Date
September 1 2011
End Date
December 1 2011
Last Update
May 6 2014
Active Locations (1)
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1
Fargo, North Dakota, United States, 58104