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

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ClinicalTrials.gov Identifier: NCT00097747
Recruitment Status : Completed
First Posted : December 1, 2004
Last Update Posted : December 21, 2012
Sponsor:
Information provided by (Responsible Party):
Affymax

Study Description
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Brief Summary:
The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and minimum pharmacologically active dose of peginesatide in Healthy Volunteers.

Condition or disease Intervention/treatment Phase
Anemia Chronic Kidney Disease Chronic Renal Failure Cancer Drug: Placebo Drug: peginesatide Phase 1

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
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
Study Start Date : August 2004
Actual Primary Completion Date : January 2005
Actual Study Completion Date : January 2005
Arms and Interventions
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Arm Intervention/treatment
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


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

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

Eligibility Criteria
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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
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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
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United Kingdom
Research Facility
London, United Kingdom, HA1 3UJ
Sponsors and Collaborators
Affymax
Investigators
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Study Director: Affymax Affymax, Inc.
More Information
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Responsible Party: Affymax
ClinicalTrials.gov Identifier: NCT00097747    
Other Study ID Numbers: AFX01-0401
2004-001655-11 ( EudraCT Number )
First Posted: December 1, 2004    Key Record Dates
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:
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Kidney Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Failure, Chronic
Urologic Diseases