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

Novartis

Status and phase

Completed

Phase 1

Conditions

Renal Impairment

Treatments

Drug: AGO178C

Study type

Interventional

Funder types

Industry

Identifiers

NCT01459250

CAGO178C2104

Details and patient eligibility

About

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.

Enrollment

32 patients

Sex

All

Ages

18 to 79 years old

Volunteers

Accepts Healthy Volunteers

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