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Mild ModeratePhase 1NCT01442259

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

A Phase 1 study testing AFQ056 in people with Mild Moderate and or Severe Renal Impairment, run by Novartis Pharmaceuticals at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Mild Moderate, or Severe Renal Impairment
What is being tested?
AFQ056
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteGermany
Study dates
Jan 2011to Aug 2011
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Novartis Investigative Site

    Kiel

Other trials in Germany

About this study

Official title: 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.

Being tested
AFQ056
Keywords
Renal impairment,, pharmacokinetics,, safety
Medical subject headings
Renal Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AFQ056Drug

Study groups in NCT01442259
Study groupRoleWhat they receive
All study subjectsExperimentalNot described
Receives: Drug: AFQ056

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Measure: Area under the plasma concentration-time curve from time zero to infinity (AUCinf)

    Measured: 0, 0.5, 1, 2, 3, 4, 6, 12, 24, 36, 48, 72 hours post dose

  2. Measure: Area under the curve from time zero to the last measurable concentration sampling time (Tlast) [mass x time x volume-1] (AUClast)

    Measured: 0, 0.5, 1, 2, 3, 4, 6, 12, 24, 36, 48, 72 hours post dose

  3. Measure: Maximum observed plasma concentration (Cmax)

    Measured: 0, 0.5, 1, 2, 3, 4, 6, 12, 24, 36, 48, 72 hours post dose

  4. Measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)

    Measured: 0, 0.5, 1, 2, 3, 4, 6, 12, 24, 36, 48, 72 hours post dose

  5. Measure: Terminal elimination half-life (T1/2)

    Measured: 0, 0.5, 1, 2, 3, 4, 6, 12, 24, 36, 48, 72 hours post dose

  6. Measure: The apparent systemic (or total body) clearance from plasma following extravascular administration [volume / time] (CL/F)

    Measured: 0, 0.5, 1, 2, 3, 4, 6, 12, 24, 36, 48, 72 hours post dose

  7. Measure: The apparent volume of distribution during the terminal elimination phase following oral administration [volume] (Vz/F)

    Measured: 0, 0.5, 1, 2, 3, 4, 6, 12, 24, 36, 48, 72 hours post dose

  8. 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)

    Measured: 4 days

  9. Measure: The renal clearance from plasma [volume / time] (CLr)

    Measured: 4 days

Secondary outcomes (9)

  1. Physical examination

    Measured: Screening, Day -1, Day 8 +/- 2 days

  2. Measure: Vital signs and body measurements

    Measured: Screening, Day -1, Day 1, Day 8 +/- 2 days

  3. Measure: ECG

    Measured: Screening, Day -1, Day 1, Day 8 +/- 2 days

  4. Measure: pulse oximetry

    Measured: Screening, Day -1, Day 1, Day 8 +/- 2 days

  5. Measure: hematology

    Measured: Screening, Day -1, Day 4, Day 8 +/- 2 days

  6. Measure: blood chemistry

    Measured: Screening, Day -1, Day 2, Day 4, Day 8 +/- 2 days

  7. Measure: urinalysis

    Measured: Screening, Day -1, Day 4, Day 8 +/- 2 days

  8. Measure: AE (adverse events) monitoring

    Measured: During the study (up to 10 days)

  9. SAE (serious adverse events) monitoring

    Measured: During the study (up to 10 days) and up to 30 days after study completion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Sep 2011 (estimated)
  2. Study startJan 2011
  3. Primary completionAug 2011
  4. Study completionAug 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Not applicable
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01442259
Sponsor's protocol ID
CAFQ056A2124
Other IDs
2010-022738-94
Status last verified
Feb 2017
First submitted
9 Sep 2011
Last updated
8 Dec 2020
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AFQ056 in people with Mild Moderate and or Severe Renal Impairment, run by Novartis Pharmaceuticals at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01442259.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2020.

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