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Single Dose Group Stratified Study in Renal Impaired and Healthy Aged and Gender Matched Subjects

NCT01318551 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2021-01-27

No results posted yet for this study

Summary

Safety, tolerability, pharmacokinetics and pharmacodynamics will be investigated in a single dose group stratified study in renal impaired and healthy subjects.

Conditions

Interventions

DRUG

BAY85-3934

single dose, 20 mg

DRUG

BAY85-3934

single dose, 40 mg (optional)

DRUG

BAY85-3934

single dose, 80 mg (optional)

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-03-16
Primary Completion
2013-09-05
Completion
2014-08-14

Countries

  • Germany

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01318551 on ClinicalTrials.gov