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

NCT00097747 | Completed Phase 1

• 2 other identifiers: AFX01-04012004-001655-11
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Adverse events

  28 Days

Secondary Outcomes (2)

• PK parameters

  28 Days

• Pharmacodynamic (PD) parameters

  28 Days

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Single injection administered intravenously

Drug: Placebo

Peginesatide 0.025 mg/kg

EXPERIMENTAL

Single peginesatide dose of 0.025 milligram per kilogram (mg/kg) administered intravenously.

Drug: peginesatide

Peginesatide 0.05 mg/kg

EXPERIMENTAL

Single peginesatide dose of 0.05 mg/kg administered intravenously.

Drug: peginesatide

Peginesatide 0.10 mg/kg

EXPERIMENTAL

Single peginesatide dose of 0.10 mg/kg administered intravenously.

Drug: peginesatide

Interventions

Placebo DRUG

Placebo

peginesatide DRUG

Also known as: Omontys, Hematide, AF37702 Injection

Peginesatide 0.025 mg/kg; Peginesatide 0.05 mg/kg; Peginesatide 0.10 mg/kg

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Affymax: lead

Study Sites (1)

Research Facility

London, HA1 3UJ, United Kingdom

Location

MeSH Terms

Conditions

Anemia; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Neoplasms

Interventions

peginesatide; hematide

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Affymax

  Affymax, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2004
• First Posted: December 1, 2004
• Study Start: August 1, 2004
• Primary Completion: January 1, 2005
• Study Completion: January 1, 2005
• Last Updated: December 21, 2012

Record last verified: 2012-12

Locations

GB (1)