Status:
COMPLETED
Pharmacokinetics, Safety and Tolerability of AGO178C in Subjects With Renal Deficiencies Compared With Healthy Subjects
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Renal Impairment
Eligibility:
All Genders
18-79 years
Phase:
PHASE1
Brief Summary
This study will assess the pharmacokinetics, safety and tolerability of a single dose of AGO178C in subjects with mild, moderate, severe renal impairment and end-stage renal disease with that in healt...
Eligibility Criteria
Inclusion
- Mild, moderate, severe renally impaired or ESRD patients.
- Healthy male or female subjects to match renally impaired patients in BMI (±15%), age (± 7 years) and gender (in this order). Smoking status (yes or no) will also be used as a final criterion, if deemed feasible by the Investigator.
Exclusion
- Pregnant or nursing (lactating) women
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless using effective contraception during the study as defined in the protocol.
- Smokers, smoking 10 cigarettes or more per day from screening to study completion
- Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the subject in case of participation in the study
- Co-medication for healthy subjects
- Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01459250
Start Date
March 1 2011
Last Update
December 8 2020
Active Locations (4)
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1
Novartis Investigative Site
Miami, Florida, United States, 33136
2
Novartis Investigative Site
Orlando, Florida, United States, 32809-3017
3
Novartis Investigative Site
Minneapolis, Minnesota, United States, 55404
4
Novartis Investigative Site
Knoxville, Tennessee, United States, 37920