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Pharmacokinetics of Eleclazine in Adults With Normal and Impaired Renal Function

NCT02441829 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2015-12-22

No results posted yet for this study

Summary

This study will evaluate the pharmacokinetics (PK), safety, and tolerability of a single oral dose of eleclazine and its metabolite, GS-623134, in participants with normal and impaired renal function. Participants in the healthy control group will be matched to participants with impaired renal function by age (± 5 years), gender, and body mass index (± 10%).

Conditions

  • Long QT Syndrome

Interventions

DRUG

Eleclazine

Eleclazine tablets administered orally in morning with food

Sponsors & Collaborators

Principal Investigators

  • Brian McNabb, MD · Gilead Sciences

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • United States
  • Moldova
  • Romania

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02441829 on ClinicalTrials.gov