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

Stopped early · Phase 1

Conditions studied: Severe Renal Impairment

In brief

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.

Key facts

Study ID

NCT01675973

Run by

Gilead Sciences

People needed

4

Starts

2012-07-01

Expected to finish

2012-08-01

Last updated by the study team

2012-12-06

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• Exclusion criteria (All Cohorts):
• 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
• 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
• Exclusion criteria (Cohort B, Severe RI):
• 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)

Where it is running

• Clinical Pharmacology of Miami — Miami, Florida, United States

Full record on ClinicalTrials.gov

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