- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01458028
Age and Gender Effects on the Pharmacokinetics of BAY85-3934
May 5, 2014 updated by: Bayer
A Parallel Group, Double-Blind Study to Evaluate the Effects of Age and Gender on the Single-Dose Pharmacokinetics of BAY85-3934, Tablet Formulation
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
48
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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North Dakota
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Fargo, North Dakota, United States, 58104
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm 1
|
Single doses of 20 mg BAY85-3934 as tablet
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Placebo Comparator: Arm 2
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Single dose of placebo tablet matching the 20 mg BAY85-3934 tablet
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
Measured over 72 hours after dosing
|
Maximum drug concentration in plasma after single dose administration of BAY85-3934
Time Frame: Measured over 72 hours after dosing
|
Measured over 72 hours after dosing
|
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
|
Measured over 96 hours after dosing
|
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
|
Measured over 96 hours after dosing
|
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
|
Measured over 72 hours after dosing
|
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
|
Measured over 48 hours after dosing
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pharmacodynamic effects on erythropoietin as the change from baseline at 48 hours
Time Frame: 48 hours post dose
|
48 hours post dose
|
Pharmacodynamic effects on reticulocytes as the change from baseline at 96 hours
Time Frame: 96 hours post dose
|
96 hours post dose
|
Pharmacodynamic effects on hemoglobin as the change from baseline at 48 hours
Time Frame: 48 hours post dose
|
48 hours post dose
|
Pharmacodynamic effects on hematocrit as the change from baseline at 96 hours
Time Frame: 96 hours post dose
|
96 hours post dose
|
Pharmacodynamic effects on vascular endothelial growth factor (VEGF) as the change from baseline at 96 hours
Time Frame: 96 hours post dose
|
96 hours post dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2011
Primary Completion (Actual)
December 1, 2011
Study Completion (Actual)
December 1, 2011
Study Registration Dates
First Submitted
September 20, 2011
First Submitted That Met QC Criteria
October 21, 2011
First Posted (Estimate)
October 24, 2011
Study Record Updates
Last Update Posted (Estimate)
May 6, 2014
Last Update Submitted That Met QC Criteria
May 5, 2014
Last Verified
May 1, 2014
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 14631
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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