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

Phase 1

Completed

• Conditions: Renal Impairment
• Interventions: Drug: AGO178C

• Registration Number: NCT01459250
• Lead Sponsor: Novartis Pharmaceuticals

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 healthy matched control subjects.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Primary Completion: 2011-08
• Study First Submitted: 2011-09-23
• Status Verified: 2011-10
• Study First Submitted QC: 2011-10-21
• Study First Posted: 2011-10-25
• Last Update Submitted: 2020-12-06
• Last Update Posted: 2020-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AGO178C	AGO178C	-

Primary Outcome Measures

Name	Time	Method
Measure: Composite of AGO178C pharmacokinetics in blood and urine samples.	pre dose, 2 min, 5 min, 10 min, 20 min, 30 min, 45 min, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 12 h, 24 h and 36 h post dose

Secondary Outcome Measures

Name	Time	Method
Measure: Safety and tolerability of AGO178C as assessed by adverse events reports, vital signs, ECGs and safety laboratory tests.	Up to 9 Days post dose

Trial Locations

Locations (1)

Novartis Investigative Site; 🇺🇸 Knoxville, Tennessee, United States