Pharmacokinetics, Safety and Tolerability of AGO178C in Subjects With Renal Deficiencies Compared With Healthy Subjects
Completed · Phase 1
Conditions studied: Renal Impairment
In brief
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 healthy matched control subjects.
Key facts
- Study ID
- NCT01459250
- Run by
- Novartis Pharmaceuticals
- People needed
- 32
- Starts
- 2011-03-01
- Last updated by the study team
- 2020-12-08
Who can join
Age: 18 and older, up to 79. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Novartis Investigative Site — Miami, Florida, United States
- Novartis Investigative Site — Orlando, Florida, United States
- Novartis Investigative Site — Minneapolis, Minnesota, United States
- Novartis Investigative Site — Knoxville, Tennessee, United States
Full record on ClinicalTrials.gov
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