Safety and Pharmacokinetics of Single Intravenous Doses of Peginesatide in Healthy Volunteers - Full Text View

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:

MedlinePlus related topics: Anemia Chronic Kidney Disease Kidney Diseases Kidney Failure

U.S. FDA Resources

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:


Kidney Diseases Kidney Failure, Chronic Renal Insufficiency, Chronic Renal Insufficiency Urologic Diseases

ClinicalTrials.gov processed this record on February 27, 2015