Age and Gender Effects on the Pharmacokinetics of BAY85-3934
Completed · Phase 1 · Has a placebo group
Conditions studied: Anemia
In brief
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 facts
- Study ID
- NCT01458028
- Run by
- Bayer
- People needed
- 48
- Starts
- 2011-09-01
- Expected to finish
- 2011-12-01
- Last updated by the study team
- 2014-05-06
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Study site — Fargo, North Dakota, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.