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Severe Renal ImpairmentPhase 1NCT01675973

A Phase 1 Study to Assess the Effect of Severe Renal Impairment on the Pharmacokinetics, as Well as Safety/Tolerability, of Ranolazine

A Phase 1 study testing RANEXA in people with Severe Renal Impairment, run by Gilead Sciences at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to assess the effect of severe renal impairment on the steady-state PK, as well as safety and tolerability, of ranolazine, compared to subjects with normal renal function. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Severe Renal Impairment
What is being tested?
RANEXA
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4 participants
Where
1 siteUnited States
Study dates
Jul 2012to Aug 2012
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

  • Males and females, 18 to 75 years old, inclusive
  • Body mass index (BMI) 18 to 40 kg/m2, inclusive, at Screening
  • Females of child-bearing potential must have a negative pregnancy test at Screening and on Day -1 (Cohort A) or Day -6 (Cohort B) and must agree to use highly effective contraception methods from Screening throughout the duration of the Treatment Period and for 14 days following the last dose of study drug
  • Inclusion criteria (Cohort A [Healthy subjects with normal renal function] only):
  • Estimated creatinine clearance (CLCR), according to the Cockcroft-Gault (C-G) equation, ≥ 90 mL/min at Screening
  • Age, BMI, and sex comparable to those of subjects of Cohort B
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  • Good health status as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
  • Diagnosis of CKD
  • Estimated glomerular filtration rate (eGFR), according to the Modification of Diet in Renal Disease (MDRD) equation, < 30 mL/min/1.73 m2 (and not receiving dialysis)
  • Stable medication dose and dosing regimen for treatment of the complications of renal disease or other concomitant chronic illnesses for at least 2 weeks prior to study drug administration

Who cannot join

  • History of uncontrolled or unstable cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematopoietic, psychiatric, and/or neurological disease
  • Current or recent (within 3 months) gastrointestinal (GI) disease or any GI surgery that could impact absorption of study drug
  • Any major surgery within 4 weeks of dosing with study drug
  • Donation of blood or plasma to a blood bank or in a clinical study (except a screening visit) within 4 weeks of dosing with study drug
  • Blood transfusion within 4 weeks of dosing with study drug
  • Consumption of > 14 alcoholic drinks per week, or more than 4 alcoholic drinks on any one day
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  • History of regular use of tobacco- or nicotine-containing products in excess of 10 cigarettes per day or equivalent
  • History of substance abuse within 12 months prior to Screening
  • Positive drug screen
  • Positive alcohol test
  • Clinically significant history of hepatic disease
  • QTcF interval > 480 msec at Screening or Day -6 (for Cohort B) or Day -1 (for Cohort A)
  • History of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmia, or torsade de pointes
  • Known hypersensitivity or previous intolerance to ranolazine or any of its excipients
  • Treatment with selected medications
  • Pregnancy or lactation
  • Other condition(s) that, in the opinion of the Investigator, would prevent compliance with the study protocol
  • Exclusion criteria (Cohort A [Healthy subjects with normal renal function] only):
  • Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG, or clinical laboratory determinations
  • Hemoglobin < 12 g/dL for males, < 11 g/dL for females at Screening
  • Any prescription and over-the-counter medications, including herbal products
  • Any clinical, ECG, and laboratory findings beyond those which are consistent with the degree of renal dysfunction
  • History of or anticipated near-term need for renal transplant (within 3 months)
  • History of hemodialysis or peritoneal dialysis within 1 year prior to Screening, or anticipated need for hemodialysis or peritoneal dialysis during the study
  • History of acute renal failure or nephrotic syndrome within 1 year prior to Screening
  • History of diabetic ketoacidosis
  • History of severe hypoglycemia
  • Other condition(s) that, in the opinion of the Investigator, would prevent compliance with the study protocol

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Clinical Pharmacology of Miami

    Miami, Florida, 33014

Other trials in United States

About this study

Official title: A Phase 1, Parallel-group, Open-label, Multiple-dose Study to Assess the Pharmacokinetics, Safety, and Tolerability of Ranolazine ER in Subjects With Severe Renal Impairment as Compared to Healthy Subjects With Normal Renal Function

The purpose of this study is to assess the effect of severe renal impairment on the steady-state PK, as well as safety and tolerability, of ranolazine, compared to subjects with normal renal function.

Read the detailed description

The primary objective of this study is to assess the effects of severe renal impairment (RI) on the steady-state pharmacokinetics (PK) of ranolazine and key metabolites. The secondary objective of this study is to assess the safety and tolerability of multiple oral doses of ranolazine in subjects with severe RI.

Being tested
RANEXA
Keywords
Ranolazine, renal impairment
Medical subject headings
Renal Insufficiency

What participants receive

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

  • RANEXADrug

    500mg BID up to 1000mg BID

Study groups in NCT01675973
Study groupRoleWhat they receive
Subjects with severe renal impairmentExperimentalCohort B (subjects with severe RI): Approximately 10 subjects will be enrolled to obtain approximately 8 evaluable subjects.
Receives: Drug: RANEXA
Subjects with normal renal functionExperimentalCohort A (healthy subjects with normal renal function): Approximately 10 subjects will be enrolled to obtain approximately 8 evaluable subjects.
Receives: Drug: RANEXA

What is being measured

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

  1. Area under the plasma concentration vs time curve over the dosing interval at steady state (AUCtau) and Maximum observed plasma concentration at steady-state (Cmax)

    • Maximum observed plasma ranolazine concentration at steady-state (Cmax) [Time frame: 0, 1, 2, 3, 4, 6, 8, 10, and 12 hours post-dose on Day 7 for Cohort A and Days -1 and 7 for Cohort B]
    • Area under the plasma ranolazine concentration versus time curve over the dosing interval at steady state (AUCtau) [Time frame: 0, 1, 2, 3, 4, 6, 8, 10, and 12 hours post-dose on Day 7 for Cohort A and Days -1 and 7 for Cohort B]

    Measured: Day 7 for Cohorts A & B, and Day -1 for Cohort B only.

Secondary outcomes (1)

  1. Number of subjects with AEs

    Measured: From Day -5 for Cohort B or Day 1 for Cohort A through the 14-day follow-up.

Timeline

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

  1. First posted30 Aug 2012 (estimated)
  2. Study startJul 2012
  3. Primary completionAug 2012
  4. Study completionAug 2012

Why it stopped: Study met stopping criteria specified within protocol.

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
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01675973
Sponsor's protocol ID
GS-US-259-0112
Status last verified
Dec 2012
First submitted
26 Jul 2012
Last updated
6 Dec 2012
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing RANEXA in people with Severe Renal Impairment, run by Gilead Sciences at 1 site 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 10 inclusion and 28 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: stopped early, as of the sponsor's last update on 6 Dec 2012. 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 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 was stopped early (reason given: Study met stopping criteria specified within protocol.). Results are not available in the source record.

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 vs time curve over the dosing interval at steady state (AUCtau) and Maximum observed plasma concentration at steady-state (Cmax) (time frame: Day 7 for Cohorts A & B, and Day -1 for Cohort B only.). 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 NCT01675973.

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 6 Dec 2012.

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