Status:
COMPLETED
Study to Investigate the Natriuretic Effects, Safety, Tolerability and Pharmacokinetics of BAY94-8862
Lead Sponsor:
Bayer
Conditions:
Clinical Pharmacology
Eligibility:
MALE
18-46 years
Phase:
PHASE1
Brief Summary
Pharmacodynamics, pharmacokinetics, safety, and tolerability will be investigated in this single dose study. In 5 treatment groups, different dosages of BAY94-8862 will be given in healthy male subjec...
Detailed Description
Clinical pharmacology
Eligibility Criteria
Inclusion
- Healthy male white subjects
- 18 to 46 years of age
- Body mass index (BMI): 18 - 29.9 kg/m²
Exclusion
- Clinically relevant findings in medical history or in the physical examination
- Systolic blood pressure below 100 or above 140 mmHg
- Diastolic blood pressure below 50 or above 90 mmHg
- Heart rate below 45 or above 95 beats / min
Key Trial Info
Start Date :
March 29 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 17 2011
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT01473108
Start Date
March 29 2010
End Date
May 17 2011
Last Update
February 9 2022
Active Locations (1)
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1
Neuss, North Rhine-Westphalia, Germany, 41460