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

Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00097747
• Other study ID #: AFX01-0401
• Secondary ID: 2004-001655-11
• Status: Completed
• Phase: Phase 1
• First received: November 30, 2004
• Last updated: December 19, 2012
• Start date: August 2004
• Est. completion date: January 2005

Study information

• Verified date: December 2012
• Source: Affymax
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: January 2005
• Est. primary completion date: January 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia
• Cancer
• Chronic Kidney Disease
• Chronic Renal Failure
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Drug:
• Placebo

• peginesatide

Locations

Country	Name	City	State
United Kingdom	Research Facility	London

Sponsors (1)

Lead Sponsor	Collaborator
Affymax

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events		28 Days	Yes
Secondary	PK parameters		28 Days	No
Secondary	Pharmacodynamic (PD) parameters		28 Days	No