- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01442259
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Kiel, Germany
- Novartis Investigative Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: All study subjects
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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0, 0.5, 1, 2, 3, 4, 6, 12, 24, 36, 48, 72 hours post dose
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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
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0, 0.5, 1, 2, 3, 4, 6, 12, 24, 36, 48, 72 hours post dose
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Measure: Maximum observed plasma concentration (Cmax)
Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 12, 24, 36, 48, 72 hours post dose
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0, 0.5, 1, 2, 3, 4, 6, 12, 24, 36, 48, 72 hours post dose
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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
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0, 0.5, 1, 2, 3, 4, 6, 12, 24, 36, 48, 72 hours post dose
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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
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0, 0.5, 1, 2, 3, 4, 6, 12, 24, 36, 48, 72 hours post dose
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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
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0, 0.5, 1, 2, 3, 4, 6, 12, 24, 36, 48, 72 hours post dose
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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
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0, 0.5, 1, 2, 3, 4, 6, 12, 24, 36, 48, 72 hours post dose
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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
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4 days
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Measure: The renal clearance from plasma [volume / time] (CLr)
Time Frame: 4 days
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4 days
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Physical examination
Time Frame: Screening, Day -1, Day 8 +/- 2 days
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Screening, Day -1, Day 8 +/- 2 days
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Measure: Vital signs and body measurements
Time Frame: Screening, Day -1, Day 1, Day 8 +/- 2 days
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Screening, Day -1, Day 1, Day 8 +/- 2 days
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Measure: ECG
Time Frame: Screening, Day -1, Day 1, Day 8 +/- 2 days
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Screening, Day -1, Day 1, Day 8 +/- 2 days
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Measure: pulse oximetry
Time Frame: Screening, Day -1, Day 1, Day 8 +/- 2 days
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Screening, Day -1, Day 1, Day 8 +/- 2 days
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Measure: hematology
Time Frame: Screening, Day -1, Day 4, Day 8 +/- 2 days
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Screening, Day -1, Day 4, Day 8 +/- 2 days
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Measure: blood chemistry
Time Frame: Screening, Day -1, Day 2, Day 4, Day 8 +/- 2 days
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Screening, Day -1, Day 2, Day 4, Day 8 +/- 2 days
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Measure: urinalysis
Time Frame: Screening, Day -1, Day 4, Day 8 +/- 2 days
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Screening, Day -1, Day 4, Day 8 +/- 2 days
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Measure: AE (adverse events) monitoring
Time Frame: During the study (up to 10 days)
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During the study (up to 10 days)
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SAE (serious adverse events) monitoring
Time Frame: During the study (up to 10 days) and up to 30 days after study completion
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During the study (up to 10 days) and up to 30 days after study completion
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CAFQ056A2124
- 2010-022738-94 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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