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Renal ImpairmentPhase 1NCT01558323

Pharmacokinetics of LCQ908 in Patients With Renal Impairment

A Phase 1 study testing LCQ908 in people with Renal Impairment, run by Novartis Pharmaceuticals at 2 sites in United States.

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

This study will compare the pharmacokinetics of LCQ908 in subjects with varying degrees of renal impairment to healthy subjects Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Renal Impairment
What is being tested?
LCQ908
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
58 participants
Where
2 sitesUnited States
Study dates
May 2012to Mar 2013
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

  • Individuals with renal impairment only
  • Estimated Creatinine Clearance (CLcr) by the Cockroft-Gault equation ≤80mL/min;
  • Mild renal impairment defined as CLcr 50-80 mL/min
  • Moderate renal impairment defined as CLcr 30-50 mL/min
  • Severe renal impairment defined as CLcr <30 mL/min
  • Healthy subjects only • Estimated CLcr by the Cockroft-Gault equation >80mL/min

Who cannot join

  • All Individuals
  • A past medical history of clinically significant ECG abnormalities or a family history of a prolonged QT-interval syndrome.
  • Female subjects must be of non child bearing potential or use an effective method of contraception.
  • Individuals with renal impairment
  • Renal transplant at any time.
  • Subjects undergoing any method of dialysis (hemodialysis, peritoneal dialysis) within the last 3 months.
Show all 13Show fewer
  • History of clinically significant chronic or recurrent urinary tract infection active and requiring antibiotic treatment within the past 30 days.
  • Any medication that is contraindicated in moderate or severe renally impaired population
  • Healthy subjects
  • History or presence of impaired renal function as indicated by clinically significantly abnormal creatinine or BUN and/or urea values, or abnormal urinary constituents (e.g., albuminuria)
  • Evidence of urinary obstruction or difficulty in voiding at screening
  • History or presence of hepatitis B or C and/or positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result at screening.
  • Other protocol-defined inclusion/exclusion criteria may apply.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Novartis Investigative Site

    Knoxville, Tennessee, 37920

  • Novartis Investigative Site

    Orlando, Florida, 32809

Other trials in United States

About this study

Official title: An Open-label, Parallel-group, Single Dose Study to Assess the Pharmacokinetics of LCQ908 in Patients With Mild, Moderate and Severe Renal Impairment Compared to Age, Gender and Weight-matched Healthy Volunteers.

This study will compare the pharmacokinetics of LCQ908 in subjects with varying degrees of renal impairment to healthy subjects

Being tested
LCQ908
Keywords
LCQ908, Renal Impairment, Pharmacokinetics
Medical subject headings
Renal Insufficiency

What participants receive

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

  • LCQ908Drug

    Participants will receive a single oral dose of LCQ908

Study groups in NCT01558323
Study groupRoleWhat they receive
LCQ908 (mild renal impairment plus healthy volunteers)ExperimentalHealthy subjects will be matched pair-wise by, sex, race, age (±15 years) and weight (±20%) to subjects with mild renal impairment and will receive a single 40 mg dose of LCQ908.
Receives: Drug: LCQ908
LCQ908 (moderate renal impairment plus healthy volunteers)ExperimentalHealthy subjects will be matched pair-wise by, sex, race, age (±15 years) and weight (±20%) to subjects with moderate renal impairment and will receive a single 40 mg dose of LCQ908.
Receives: Drug: LCQ908
LCQ908 (severe renal impairment plus healthy volunteers)ExperimentalHealthy subjects will be matched pair-wise by, sex, race, age (±15 years) and weight (±20%) to subjects with severe renal impairment and will receive a single 40 mg dose of LCQ908.
Receives: Drug: LCQ908

What is being measured

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

  1. Area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (AUClast) of LCQ908

    Measured: Serial blood draws conducted on Day 1 (treatment day) followed by additional blood draws on Days 2-10,12, 14, 17, 21 and 29 post dosing

  2. Area under the plasma concentration-time profile from time zero extrapolated to infinite time [AUC(0-inf)] of LCQ908

    Measured: Serial blood draws conducted on Day 1 (treatment day) followed by additional blood draws on Days 2-10,12, 14, 17, 21 and 29 post dosing

  3. Maximum plasma concentration (Cmax) of LCQ908

    Measured: Serial blood draws conducted on Day 1 (treatment day) followed by additional blood draws on Days 2-10,12, 14, 17, 21 and 29 post dosing

Secondary outcomes (8)

  1. Number of participants with adverse events (AEs), serious adverse events (SAEs) and death

    AEs are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. SAEs are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital abnormalities or birth defects, or are other conditions which in the judgment of investigators represent significant hazards.

    Measured: Day 29

  2. The apparent systemic clearance (CL/F) of LCQ908 following extra vascular administration

    Measured: Serial blood draws conducted on Day 1 (treatment day) followed by additional blood draws on Days 2-10,12, 14, 17, 21 and 29 post dosing

  3. Time to maximum plasma concentration of LCQ908

    Measured: Serial blood draws conducted on Day 1 (treatment day) followed by additional blood draws on Days 2-10,12, 14, 17, 21 and 29 post dosing

  4. The time required for the concentration of the drug to reach half of its original value

    Measured: Serial blood draws conducted on Day 1 (treatment day) followed by additional blood draws on Days 2-10,12, 14, 17, 21 and 29 post dosing

  5. Apparent volume of distribution of LCQ908 during the terminal elimination phase following extra vascular administration

    Measured: Serial blood draws conducted on Day 1 (treatment day) followed by additional blood draws on Days 2-10,12, 14, 17, 21 and 29 post dosing

  6. LCQ908 protein binding: unbound area under curve (AUCc) of LCQ908

    Measured: 10 and 24 hours

  7. LCQ908 protein binding: unbound observed maximum plasma (Cmax) of LCQ908

    Measured: 10 and 24 hours

  8. LCQ908 protein binding: unbound apparent systemic clearance from plasma (CL/Fu) following extra vascular administration

    Measured: 10 and 24 hours

Timeline

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

  1. First posted20 Mar 2012 (estimated)
  2. Study startMay 2012
  3. Primary completionMar 2013
  4. Study completionMar 2013

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
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
58 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01558323
Sponsor's protocol ID
CLCQ908B2102
Status last verified
Jan 2014
First submitted
14 Mar 2012
Last updated
19 Dec 2020
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LCQ908 in people with Renal Impairment, run by Novartis Pharmaceuticals at 2 sites in United States.

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 6 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 19 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 2 sites in United States. 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?

Area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (AUClast) of LCQ908 (time frame: Serial blood draws conducted on Day 1 (treatment day) followed by additional blood draws on Days 2-10,12, 14, 17, 21 and 29 post dosing). The study lists 3 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 NCT01558323.

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 19 Dec 2020.

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