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Study to Assess the Safety and the Phosphate Binding Capacity of Renazorb

NCT01560884 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2013-11-08

No results posted yet for this study

Summary

The purpose of this trial is to study safety, tolerability, and phosphate binding capacity of Renazorb (SPI-014) in healthy volunteers before conducting trials in patients with renal failure. Renal excretion of phosphate is expected to decrease and fecal excretion of phosphate is expected to increase after treatment.

Conditions

  • Safety
  • Phosphate Binding Capacity

Interventions

DRUG

Renazorb 1500 mg/day

Six subjects will be randomly assigned to receive SPI-014 1500 mg/day dose and 2 subjects to receive placebo

DRUG

Renazorb 3000 mg/day

Six subjects will be randomly assigned to receive SPI-014 3000 mg/day dose and 2 subjects to receive placebo

DRUG

Renazorb 4500 mg/day

Six subjects will be randomly assigned to receive SPI-014 4500 mg/day dose and 2 subjects to receive placebo

DRUG

Renazorb 6000 mg/day

Six subjects will be randomly assigned to receive SPI-014 6000 mg/day dose and 2 subjects to receive placebo

Sponsors & Collaborators

  • Spectrum Pharmaceuticals, Inc

    lead INDUSTRY

Principal Investigators

  • Ronald Goldwater · PAREXEL, Harbor Hospital Center, Baltimore, MD 21225

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2012-09-30
Completion
2012-09-30

Countries

  • United States

Study Locations

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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 NCT01560884 on ClinicalTrials.gov