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An Open-label, Parallel-group Study to Determine the Pharmacokinetics of a Single Dose of AFQ056 in Subjects With Renal Impairment Compared to Healthy Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01442259
First received: September 9, 2011
Last updated: February 28, 2017
Last verified: February 2017

September 9, 2011
February 28, 2017
January 2011
August 2011   (Final data collection date for primary outcome measure)
  • Measure: Area under the plasma concentration-time curve from time zero to infinity (AUCinf) [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 12, 24, 36, 48, 72 hours post dose ]
  • Measure: Area under the curve from time zero to the last measurable concentration sampling time (Tlast) [mass x time x volume-1] (AUClast) [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 12, 24, 36, 48, 72 hours post dose ]
  • Measure: Maximum observed plasma concentration (Cmax) [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 12, 24, 36, 48, 72 hours post dose ]
  • Measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 12, 24, 36, 48, 72 hours post dose ]
  • Measure: Terminal elimination half-life (T1/2) [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 12, 24, 36, 48, 72 hours post dose ]
  • Measure: The apparent systemic (or total body) clearance from plasma following extravascular administration [volume / time] (CL/F) [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 12, 24, 36, 48, 72 hours post dose ]
  • Measure: The apparent volume of distribution during the terminal elimination phase following oral administration [volume] (Vz/F) [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 12, 24, 36, 48, 72 hours post dose ]
  • Measure: Amount of drug excreted into the urine from time zero to time't' where t is a defined time point after administration [mass units or % of dose] (Ae0-t) [ Time Frame: 4 days ]
  • Measure: The renal clearance from plasma [volume / time] (CLr) [ Time Frame: 4 days ]
Profile of PK parameters (AUClast, AUCinf and Cmax) were compared between each renally impaired group (mild, moderate and severe respectively) vs. the matched control group [ Time Frame: Several timepoins for 4 days after the single AFQ056 dose administration ]
Complete list of historical versions of study NCT01442259 on ClinicalTrials.gov Archive Site
  • Physical examination [ Time Frame: Screening, Day -1, Day 8 +/- 2 days ]
  • Measure: Vital signs and body measurements [ Time Frame: Screening, Day -1, Day 1, Day 8 +/- 2 days ]
  • Measure: ECG [ Time Frame: Screening, Day -1, Day 1, Day 8 +/- 2 days ]
  • Measure: pulse oximetry [ Time Frame: Screening, Day -1, Day 1, Day 8 +/- 2 days ]
  • Measure: hematology [ Time Frame: Screening, Day -1, Day 4, Day 8 +/- 2 days ]
  • Measure: blood chemistry [ Time Frame: Screening, Day -1, Day 2, Day 4, Day 8 +/- 2 days ]
  • Measure: urinalysis [ Time Frame: Screening, Day -1, Day 4, Day 8 +/- 2 days ]
  • Measure: AE (adverse events) monitoring [ Time Frame: During the study (up to 10 days) ]
  • SAE (serious adverse events) monitoring [ Time Frame: During the study (up to 10 days) and up to 30 days after study completion ]
  • Physical examination [ Time Frame: Screening, Day -1, Day 8 +/- 2 days ]
  • Measure: Vital signs and body measurements [ Time Frame: Screening, Day -1, Day 1, Day 8 +/- 2 days ]
  • Measure: ECG [ Time Frame: Screening, Day -1, Day 1, Day 8 +/- 2 days ]
  • Measure: pulse oximetry [ Time Frame: Screening, Day -1, Day 1, Day 8 +/- 2 days ]
  • Measure: hematology [ Time Frame: Screening, Day -1, Day 4, Day 8 +/- 2 days ]
  • Measure: blood chemistry [ Time Frame: Screening, Day -1, Day 2, Day 4, Day 8 +/- 2 days ]
  • Measure: urinalysis [ Time Frame: Screening, Day -1, Day 4, Day 8 +/- 2 days ]
  • Measure: AE (adverse events) monitoring [ Time Frame: During the study ]
  • SAE (serious adverse events) monitoring [ Time Frame: During the study and up to 30 days after study completion ]
Not Provided
Not Provided
 
An Open-label, Parallel-group Study to Determine the Pharmacokinetics of a Single Dose of AFQ056 in Subjects With Renal Impairment Compared to Healthy Subjects
An Open-label, Parallel-group Study to Determine the Pharmacokinetics of a Single Dose of AFQ056 in Subjects With Mild, Moderate or Severe Renal Impairment Compared to Age, Sex, and Body Weight-matched Healthy Subjects
The aim of this study was to characterize the pharmacokinetics and safety of AFQ056 in subjects with a different degree of renal impairment.
Not Provided
Interventional
Phase 1
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Other
  • Mild Moderate
  • or Severe Renal Impairment
Drug: AFQ056
Experimental: All study subjects
Intervention: Drug: AFQ056
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
August 2011
August 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Written informed consent must be obtained before any assessment is performed.
  • Female subjects must be of non-child bearing potential as defined as postmenopausal females with no regular menstrual bleeding for at least 1 year prior to inclusion
  • Body weight: ≥50kg; BMI: 18-34 kg/m2
  • Ability to communicate well with the investigator and comply with the requirements of the study.

For subjects with renal impairment only

  • No current clinically significant disease (other than renal impairment), except for stable underlying disease that caused renal impairment, as determined by clinical history and physical examination.
  • MDRD-calculated eGFR of <90 mL/min/1.73 m2 based on serum creatinine
  • Vital signs (after 3 minutes resting measured in the supine position) should be within normal ranges as deemed by the Investigator.

For healthy subjects only

  • No current clinically significant disease as determined by clinical history and physical examination.
  • MDRD-calculated eGFR of ≥90 mL/min/1.73 m2 based on serum creatinine.
  • Vital signs (after 3 minutes resting measured in the supine position) should be within normal ranges as deemed by the Investigator.

Exclusion Criteria:

  • Pregnant or nursing (lactating) females
  • Use of any prescription or over-the-counter (OTC) drugs, herbal (e.g. St. John's wort) ordietary supplements (e.g. broccoli, vitamins) within three weeks or five half lives(whichever is longer) prior to dosing with AFQ056 until study completion. This does not include drugs that are used as (symptomatic) treatment of renal impairment (e.g. antihypertensive and antidiabetic drugs) provided such drugs are:

    • used at the same dose within three weeks or five half lives (whichever is longer) prior to dosing with AFQ056 until study completion.
    • not known as inhibitors or inducers of CYP1A1, 1A2, 2C8, 2C9, 2C19, 3A4, 3A5 gp).
  • Participation in any clinical investigation or use of any investigational drug within 30 days or five (5) half-lives of a given investigational drug (whichever period is longer); or longer if required by local regulations prior to screening until study completion
  • Donation or loss of 400 mL or more of blood within 8 weeks prior to first dosing, or longer if required by local regulation.
  • History of renal transplantation
  • History or presence of prolonged QTc interval (males: >450ms; females: > 470 ms), 2nd or 3rd degree AV-block or any other clinically significant ECG abnormalities as determined by medical history and 12-lead ECG recordings at screening and baseline 1.
  • History or presence of any clinically significant disease of any major system organ class, within the past 2 years prior to screening, except for renal impairment and underlying diseases causing renal impairment for the subject belonging to the renal impairment groups.
  • Subjects undergoing any method of dialysis (hemodialysis or peritoneal dialysis)
  • History of or ongoing active substance abuse (including alcohol) within the past 2 years.
  • Smokers (use of tobacco products in the previous 3 months). Urine cotinine levels will be measured during Screening and at Baseline for all subjects. Smokers will be defined as any subject who reports tobacco use and/or who has a urine cotinine ≥ 500 ng/mL at screening

Other protocol-defined inclusion/exclusion criteria may apply.

Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01442259
CAFQ056A2124
2010-022738-94 ( EudraCT Number )
Not Provided
Not Provided
Not Provided
Not Provided
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP