Trial Condition(s):

Anemia

Age and Gender Effects on the Pharmacokinetics of BAY85-3934

Bayer Identifier:

14631

ClinicalTrials.gov Identifier:

NCT01458028

EudraCT Number:

Not Available

Study Completed

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.

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
48
Trial Dates
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Phase
1
Could I receive a placebo?
Yes
Products
Molidustat (BAY85-3934)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

Cetero Research

Fargo, United States, 58104

Status
Completed
 

Trial Design