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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Affymax
ClinicalTrials.gov Identifier:
NCT00097747
First received: November 30, 2004
Last updated: December 19, 2012
Last verified: December 2012
  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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Affymax:

Primary Outcome Measures:
  • Adverse events [ Time Frame: 28 Days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • PK parameters [ Time Frame: 28 Days ] [ Designated as safety issue: No ]
  • Pharmacodynamic (PD) parameters [ Time Frame: 28 Days ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 40 Years
Genders 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
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: NCT00097747

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

No publications provided

Responsible Party: Affymax
ClinicalTrials.gov Identifier: NCT00097747     History of Changes
Other Study ID Numbers: AFX01-0401, 2004-001655-11
Study First Received: November 30, 2004
Last Updated: December 19, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee

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:
Anemia
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency
Renal Insufficiency, Chronic
Hematologic Diseases
Urologic Diseases
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 31, 2014