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

NCT ID: NCT01442259

Last Updated: 2020-12-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2011-08-31

Brief Summary

The aim of this study was to characterize the pharmacokinetics and safety of AFQ056 in subjects with a different degree of renal impairment.

Conditions

Mild Moderate; or Severe Renal Impairment

Keywords

Renal impairment,; pharmacokinetics,; safety

Study Design

• Allocation Method: NA
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

All study subjects

Group Type: EXPERIMENTAL

AFQ056

Intervention Type: DRUG

Interventions

AFQ056

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Novartis Investigative Site

Kiel, , Germany

Countries

Germany

Related Links

https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=6624

Results for CAFQ056A2124 can be found on the Novartis Clinical Trial Results Website

Other Identifiers

2010-022738-94

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CAFQ056A2124

Identifier Type: -

Identifier Source: org_study_id