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Safety and Pharmacokinetics of Single Intravenous Doses of Peginesatide in Healthy Volunteers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00097747
First Posted: December 1, 2004
Last Update Posted: December 21, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Affymax
  Purpose
The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and minimum pharmacologically active dose of peginesatide in Healthy Volunteers.

Condition Intervention Phase
Anemia Chronic Kidney Disease Chronic Renal Failure Cancer Drug: Placebo Drug: peginesatide Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 1, Double-blind, Placebo-controlled, Dose Escalation Study of the Safety and Pharmacokinetics of Single Intravenous Doses of Peginesatide in Healthy Volunteers

Further study details as provided by Affymax:

Primary Outcome Measures:
  • Adverse events [ Time Frame: 28 Days ]

Secondary Outcome Measures:
  • PK parameters [ Time Frame: 28 Days ]
  • Pharmacodynamic (PD) parameters [ Time Frame: 28 Days ]

Enrollment: 28
Study Start Date: August 2004
Study Completion Date: January 2005
Primary Completion Date: January 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Single injection administered intravenously
Drug: Placebo
Experimental: Peginesatide 0.025 mg/kg
Single peginesatide dose of 0.025 milligram per kilogram (mg/kg) administered intravenously.
Drug: peginesatide
Other Names:
  • Omontys
  • Hematide
  • AF37702 Injection
Experimental: Peginesatide 0.05 mg/kg
Single peginesatide dose of 0.05 mg/kg administered intravenously.
Drug: peginesatide
Other Names:
  • Omontys
  • Hematide
  • AF37702 Injection
Experimental: Peginesatide 0.10 mg/kg
Single peginesatide dose of 0.10 mg/kg administered intravenously.
Drug: peginesatide
Other Names:
  • Omontys
  • Hematide
  • AF37702 Injection

Detailed Description:
This was a Phase 1, double-blind, placebo-controlled trial of peginesatide, an erythropoiesis stimulating agent, with approximately 7 treatment cohorts and 7 healthy volunteer participants per cohort. In each cohort of 7 participants, a ratio of 5:2 participants was randomly assigned to receive a single dose of peginesatide or placebo, respectively, administered as an intravenous infusion. Planned peginesatide dose levels were to escalate by cohort. The study was conducted at a single clinical center.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Main eligibility criteria:

  • Participant is a healthy male, age ≥ 18 years and ≤ 40 years, with body mass index (BMI) ≥ 18 and ≤ 30 kilograms per squared meter (kg/m^2), and weight ≥ 50 and ≤ 95 kilograms (kg)
  • Participant has hemoglobin of ≤ 16 grams per deciliter (g/dL) at the time of study entry
  • Participant has normal iron stores
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00097747


Locations
United Kingdom
Research Facility
London, United Kingdom, HA1 3UJ
Sponsors and Collaborators
Affymax
Investigators
Study Director: Affymax Affymax, Inc.
  More Information

Responsible Party: Affymax
ClinicalTrials.gov Identifier: NCT00097747     History of Changes
Other Study ID Numbers: AFX01-0401
2004-001655-11 ( EudraCT Number )
First Submitted: November 30, 2004
First Posted: December 1, 2004
Last Update Posted: December 21, 2012
Last Verified: December 2012

Keywords provided by Affymax:
anemia
chronic kidney disease
CKD
chronic renal failure
CRF
erythropoietin
EPO
erythropoiesis stimulating agent
ESA
Hematide™
hemoglobin
Hb
Hgb
Omontys
peginesatide
red blood cell
red blood cell production

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Failure, Chronic
Urologic Diseases