Back to resultsSafety and Pharmacokinetics of Single Intravenous Doses of Peginesatide in Healthy Volunteers
Primary Purpose
Anemia, Chronic Kidney Disease, Chronic Renal Failure
Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
Placebo
peginesatide
Sponsored by
About this trial
This is an interventional treatment trial for Anemia focused on measuring 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
Eligibility 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
Sites / Locations
- Research Facility
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Experimental
Experimental
Experimental
Arm Label
Placebo
Peginesatide 0.025 mg/kg
Peginesatide 0.05 mg/kg
Peginesatide 0.10 mg/kg
Arm Description
Single injection administered intravenously
Single peginesatide dose of 0.025 milligram per kilogram (mg/kg) administered intravenously.
Single peginesatide dose of 0.05 mg/kg administered intravenously.
Single peginesatide dose of 0.10 mg/kg administered intravenously.
Outcomes
Primary Outcome Measures
Adverse events
Secondary Outcome Measures
PK parameters
Pharmacodynamic (PD) parameters
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00097747
Brief Title
Safety and Pharmacokinetics of Single Intravenous Doses of Peginesatide in Healthy Volunteers
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 Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
January 2005 (Actual)
Study Completion Date
January 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Affymax
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and minimum pharmacologically active dose of peginesatide in Healthy Volunteers.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia, Chronic Kidney Disease, Chronic Renal Failure, Cancer
Keywords
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Single injection administered intravenously
Arm Title
Peginesatide 0.025 mg/kg
Arm Type
Experimental
Arm Description
Single peginesatide dose of 0.025 milligram per kilogram (mg/kg) administered intravenously.
Arm Title
Peginesatide 0.05 mg/kg
Arm Type
Experimental
Arm Description
Single peginesatide dose of 0.05 mg/kg administered intravenously.
Arm Title
Peginesatide 0.10 mg/kg
Arm Type
Experimental
Arm Description
Single peginesatide dose of 0.10 mg/kg administered intravenously.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Type
Drug
Intervention Name(s)
peginesatide
Other Intervention Name(s)
Omontys, Hematide, AF37702 Injection
Primary Outcome Measure Information:
Title
Adverse events
Time Frame
28 Days
Secondary Outcome Measure Information:
Title
PK parameters
Time Frame
28 Days
Title
Pharmacodynamic (PD) parameters
Time Frame
28 Days
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Affymax
Organizational Affiliation
Affymax, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Research Facility
City
London
ZIP/Postal Code
HA1 3UJ
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Safety and Pharmacokinetics of Single Intravenous Doses of Peginesatide in Healthy Volunteers
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