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

This study has been completed.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals ) Identifier:
First received: September 23, 2011
Last updated: October 21, 2011
Last verified: October 2011

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.

Condition Intervention Phase
Renal Impairment
Drug: AGO178C
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: An Open Label, Non-randomised, Parallel Group Study to Characterise and Compare 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

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Measure: Composite of AGO178C pharmacokinetics in blood and urine samples. [ Time Frame: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Measure: Safety and tolerability of AGO178C as assessed by adverse events reports, vital signs, ECGs and safety laboratory tests. [ Time Frame: Up to 9 Days post dose ] [ Designated as safety issue: Yes ]

Enrollment: 32
Study Start Date: March 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AGO178C Drug: AGO178C


Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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

  Contacts and Locations
Please refer to this study by its identifier: NCT01459250

United States, Florida
Novartis Investigative Site
Miami, Florida, United States, 33136
Novartis Investigative Site
Orlando, Florida, United States, 32809-3017
United States, Minnesota
Novartis Investigative Site
Minneapolis, Minnesota, United States, 55404
United States, Tennessee
Novartis Investigative Site
Knoxville, Tennessee, United States, 37920
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals ) Identifier: NCT01459250     History of Changes
Other Study ID Numbers: CAGO178C2104
Study First Received: September 23, 2011
Last Updated: October 21, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
renal impairment,

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases
S 20098
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses processed this record on April 17, 2014