Original Query: ALL
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01459250
Recruitment Status : Completed
First Posted : October 25, 2011
Last Update Posted : October 25, 2011
Information provided by (Responsible Party):
Novartis ( 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.

Condition or disease Intervention/treatment Phase
Renal Impairment Drug: AGO178C Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : March 2011
Primary Completion Date : August 2011

Arm Intervention/treatment
Experimental: AGO178C Drug: AGO178C

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: Novartis Pharmaceuticals Identifier: NCT01459250     History of Changes
Other Study ID Numbers: CAGO178C2104
First Posted: October 25, 2011    Key Record Dates
Last Update Posted: October 25, 2011
Last Verified: October 2011

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
renal impairment,

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases
S 20098
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs