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Study to Assess the Safety and the Phosphate Binding Capacity of Renazorb (SPI-014)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Spectrum Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT01560884
First received: March 20, 2012
Last updated: November 6, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Safety
Phosphate Binding Capacity
Drug: Renazorb 1500 mg/day
Drug: Renazorb 3000 mg/day
Drug: Renazorb 4500 mg/day
Drug: Renazorb 6000 mg/day
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: A Double Blind, Dose-Ranging, Phase 1 Study In Healthy Volunteers to Assess Safety and the Phosphate Binding Capacity of Lanthanum Dioxycarbonate (SPI-014, Renazorb)

Further study details as provided by Spectrum Pharmaceuticals, Inc:

Primary Outcome Measures:
  • Efficacy [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
    Efficacy will be evaluated by comparing difference in urine and fecal phosphorous excretion before and after treatment.


Secondary Outcome Measures:
  • Serum concentrations of lanthanum. [ Time Frame: 30 Days ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
    Safety will be evaluated by physical examinations, vital sign measurements, safety laboratory tests, ECGs, AEs, and serious adverse events (SAEs).


Enrollment: 32
Study Start Date: April 2012
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group B
Six subjects will be randomly assigned to receive SPI-014 3000 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
Other Name: Renazorb
Active Comparator: Group C
Six subjects will be randomly assigned to receive SPI-014 4500 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
Other Name: Renazorb
Active Comparator: Group D
Six subjects will be randomly assigned to receive SPI-014 6000 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
Other Name: Renazorb
Active Comparator: Group A
Six subjects will be randomly assigned to receive SPI-014 1500 mg/day dose and 2 subjects to receive placebo
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
Other Name: Renazorb

Detailed Description:

This is a double blind, dose-ranging study in healthy volunteers. Four sequential dose cohorts of 8 subjects each are planned. Six subjects will be randomly assigned to receive SPI-014 and 2 subjects to receive placebo within each cohort. The doses of SPI-014 will be 1500 mg/day (Group A), 3000 mg/day (Group B), 4500 mg/day (Group C) and 6000 mg/day (Group D), taken orally 3 times a day within 15 min after meals.

Following a screening period and evaluation of eligibility criteria, subjects will be admitted to the clinical research unit. From Day 1 to Day 10 subjects will be placed on a controlled phosphate diet (approved by a qualified dietician). From Day 1 to Day 5 (each day), 24 hour urine and feces will be collected at each voiding and pooled in separate containers for baseline phosphorus content. On Days 6 to 10, the subjects will receive SPI-014 or placebo within 15 minutes after each of the 3 main meals (see table below). From the morning of Day 8 to the morning of Day 13, 24 hour urine and feces will be collected for each day to determine phosphorus content. Subjects will be discharged on Day 13 and return 7 days later for an End-of-Study Visit on Day 20.

Starting dose will be 1500 mg/day. All safety data, including laboratory tests and adverse events, will be reviewed prior to escalation to the next cohort. After completion of first cohort, if no grades 3 AEs (vomiting and nausea) are observed in the first cohort on Day 20,Confidential 24 treatment of the second cohort begins. Similarly, third and fourth cohort will follow after the completion of the second and third cohort respectively.

Subjects will be admitted to the clinical research unit on Day -1 and remain at the clinical research unit until Day 13. From Day 1 to Day 10, subjects will consume a phosphate-controlled diet designed to provide 37.5 mmol (1200 mg) of elemental phosphorus per day (3 meals and 1 snack). The mean phosphorus contents of the meals are 12.1 mmol (387 mg), 8.6 mmol (275 mg), 12.0 mmol (416 mg), and 2.6 mmol (83 mg) for breakfast, lunch, dinner, and snack, respectively. With breakfast, the majority of the phosphorus is administered in milk. With the other meals phosphorus is primarily administered in solid food. During this 10-day treatment period subjects will be required to ingest all meals in their entirety.

The primary endpoint is phosphate binding capacity of SPI-014 as judged by levels of phosphorus in feces and urine. Phosphate excretion in urine is expected to go down and fecal excretion is expected to go up after treatment with SPI-014. Safety assessments are periodic physical examinations with vital sign measurements, safety laboratory tests, ECGs, AEs, and serious adverse events (SAEs).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male and female volunteers ≥ 18 years of age without history of significant medical disease will be enrolled.

Exclusion Criteria:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01560884

Locations
United States, Maryland
PAREXEL International - Baltimore Early Phase Clinical Unit
Baltimore, Maryland, United States, 21225
Sponsors and Collaborators
Spectrum Pharmaceuticals, Inc
Investigators
Principal Investigator: Ronald Goldwater PAREXEL, Harbor Hospital Center, Baltimore, MD 21225
  More Information

No publications provided

Responsible Party: Spectrum Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT01560884     History of Changes
Other Study ID Numbers: SPI-RZB-11-101
Study First Received: March 20, 2012
Last Updated: November 6, 2013
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on November 20, 2014