Pharmacokinetics, Safety and Tolerability of AGO178C in Subjects With Renal Deficiencies Compared With Healthy Subjects

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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 healthy matched control subjects.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: S 20098

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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