A Phase 1 Multiple Dose Study to Compare the Effects of AMG 223 and Sevelamer HCL (Renagel®)

This study has been completed.
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00756860
First received: September 11, 2008
Last updated: May 31, 2012
Last verified: May 2012
  Purpose

The purpose of this study is to determine if subjects on 2g AMG 223 will achieve 60% or greater reduction in urinary phosphorus from baseline compared to subjects on 2g Renagel®.

Renagel®, Sevelamer HCl is currently the market leader for the treatment of hyperphosphatemia in patients on dialysis.


Condition Intervention Phase
Healthy Volunteers
Drug: AMG 223
Drug: Renagel® (sevelamer hydrochloride)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1 Multiple Dose Study to Compare the Effects of AMG 223 and Sevelamer HCL (Renagel®) on Phosphate Binding in Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • To compare the effects of 2g AMG 223 and 2g Renagel® on 24 hour urinary phosphorous excretion after multiple doses in healthy volunteers. [ Time Frame: Including the 28-day Screening period, the 15-day residency period, and the follow-up on Day 15 (one week after discharge from the clinical research unit), the maximum subject participation is approximately 50 days. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To compare the effects of 2g AMG 223 and 2g Renagel® on 24 hour fecal phosphorous excretion after multiple doses in healthy volunteers. [ Time Frame: Including the 28-day Screening period, the 15-day residency period, and the follow-up on Day 15 (one week after discharge from the clinical research unit), the maximum subject participation is approximately 50 days. ] [ Designated as safety issue: No ]
  • To assess safety and tolerability of multiple doses of 2g AMG 223 in healthy volunteers. [ Time Frame: Including the 28-day Screening period, the 15-day residency period, and the follow-up on Day 15 (one week after discharge from the clinical research unit), the maximum subject participation is approximately 50 days. ] [ Designated as safety issue: No ]

Enrollment: 66
Study Start Date: May 2008
Study Completion Date: September 2009
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 2
30 subjects will be randomized on Day -1
Drug: Renagel® (sevelamer hydrochloride)
2g Renagel® (2 x 800 mg capsules + 1 x 400 mg capsule) TID on Days 1 through 7
Experimental: 1
30 subjects will be randomized on Day -1
Drug: AMG 223
2 g AMG 223 (4 x 500 mg capsules ) TID on Days 1 through 7

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy non-smoking men and women between the ages of 18 and 45 years, inclusive the time of consent. Healthy is defined as an absence of clinically relevant abnormalities, as identified by a detailed medical history, complete physical examination, vital signs, 12 lead ECG, and clinical laboratory tests at Screening through randomization Females of child-bearing potential must be non-lactating, must have a negative serum pregnancy test before study enrollment, and must use a highly effective form of contraception for at least 3 months before study drug administration, during the study, and for an additional 1 month after study completion
  • Male participants and/or their partners must use a highly effective form of contraception during sexual intercourse during the study and for an additional 1 month after study completion
  • A body mass index (BMI) between 18 and 30 kg/m2, inclusive
  • Serum phosphate within normal range
  • Willing and able to provide written informed consent
  • Willing and able to be confined to the clinical research unit (CRU) as required by the protocol
  • Must abstain from any caffeine or alcohol within 72 hours of Day-7 through Day 7 inclusive.

Exclusion Criteria:

  • Evidence or history of clinically significant hematologic, renal, endocrinologic, pulmonary, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing) judged to be relevant by the investigator
  • History of bowel obstruction, dysphagia, swallowing disorders, gastrointestinal disorders such as inflammatory bowel disease, constipation, major gastrointestinal surgery, hemorrhoids, or gastric/duodenal ulcers
  • Unable or unwilling to swallow numerous capsules/tablets
  • Known hypersensitivity to Renagel® or its constituents
  • Having an estimated glomerular filtration rate (GFR) < 80 ml/ min (Cockcroft Gault equation)
  • Blood donation > 500 mL within 60 days of Screening
  • History of alcohol abuse (more than 14 alcoholic drinks per week for men and 7 alcoholic drinks per week for women (one drink equals 12 oz beer, 8 oz of wine, or a drink containing one ounce of liquor) or use of illicit drugs within 12 months of Screening
  • Positive results for the following tests:
  • Urine drug and breath alcohol at Screening or Day -7,
  • Serum pregnancy test (females only) at Screening or Day -7,
  • Human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), or hepatitis C antibody (HepCAb) at Screening
  • Women who are pregnant, breastfeeding, or plan to become pregnant during the course of the study Participation in another clinical trial with any investigational drug or device within 30 days or 5 half lives of the investigational drug (if known), whichever is longer, of study drug administration
  • Use of prescription and nonprescription drugs (herbal remedies, vitamins, and nutraceuticals) within 14 days or 5 half-lives, whichever is longer, before Day -7 and during the study (excluding acetaminophen at doses of 2 g/day and hormonal birth control pills)
  • Use of prescription and nonprescription drugs that may affect gut motility within 14 days or 5 half-lives, whichever is longer, before Day -7 and during the study
  • Subject will not be available for follow-up assessment or concerns for subject's compliance with the protocol procedures
  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: NCT00756860

Sponsors and Collaborators
Amgen Research (Munich) GmbH
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00756860     History of Changes
Other Study ID Numbers: 20070885
Study First Received: September 11, 2008
Last Updated: May 31, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Sevelamer
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014