Safety, Pharmacokinetics (PK), And Hematological Activity Of AMD3100 (Plerixafor) In Subjects With Renal Impairment

NCT00445302 | Completed Phase 1 Results

• 1 other identifier: AMD31001101
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 3

Brief Summary

Eligible male and female subjects with renal impairment (aged 18-78 years) and healthy control subjects (aged 35 to 78 years) will be enrolled in the study. Subjects with renal impairment will be enrolled and entered into three groups based on their renal function: Mild Impairment, Moderate Impairment, and Severe Impairment(not requiring dialysis). Control subjects will have normal renal function. The screening visits will occur within 14 days prior to plerixafor administration on study day one. Subjects will be monitored for 10 hours following administration of the study drug. In addition, subjects will return to the clinic at 24 and 48 hours after plerixafor administration for blood samples and safety assessments.

Conditions

Renal Impairment

Keywords

AMD3100

Outcome Measures

Primary Outcomes (2)

• Dose-Normalized Maximum Concentration of Plerixafor (Cmax)

  Evaluation of Cmax following a single dose of 240 µg/kg plerixafor administered on Day 1. Cmax was normalized by dose.

  Pre-dose of plerixafor to 24 hours post-plerixafor

• Dose-Normalized Area Under the Plerixafor Concentration Time Curve From Time 0 to 24 Hours Post-dose (AUC0-24h)

  Evaluation of AUC0-24 hour following a single dose of 240 µg/kg plerixafor administered on Day 1. AUC0-24 was normalized by dose.

  Pre-dose of plerixafor to 24 hours post-plerixafor

Secondary Outcomes (3)

• Change From Baseline in Absolute CD34+ Cell Counts at Day 2

  Baseline, Day 2

• Change From Baseline in Absolute White Blood Cell (WBC) Counts at Day 2

  Baseline and Day 2

• Number of Participants in Overall Safety Summary of Adverse Events (TEAE)

  up to Day 3

Study Arms (4)

Normal renal function

ACTIVE COMPARATOR

Participants with normal renal function (creatinine clearance (CLcr) \> 90 ml/min) who serve as the study control. Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.

Drug: plerixafor

Mild renal impairment

EXPERIMENTAL

Participants have mild renal impairment (creatinine clearance (CLcr) = 51 to 80 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.

Drug: plerixafor

Moderate renal impairment

EXPERIMENTAL

Participants have moderate renal impairment (creatinine clearance (CLcr) = 31 to 50 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.

Drug: plerixafor

Severe renal impairment

EXPERIMENTAL

Participants have severe renal impairment (creatinine clearance (CLcr) \< 31 mL/min, not requiring dialysis). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.

Drug: plerixafor

Interventions

plerixafor DRUG

Single dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection

Also known as: Mozobil, AMD3100

Mild renal impairment; Moderate renal impairment; Normal renal function; Severe renal impairment

Eligibility Criteria

• Age: 18 Years - 78 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed patient informed consent form prior to any study procedures at Screening.
• Subject has not consumed alcohol in the 48 hours prior to the administration of study drug.
• Subject agrees to refrain from consumption of alcohol for the duration of the trial.
• Subject agrees to practice an approved method of contraception for the duration of the study.
• White blood cell count ≧3.5\*10\^9/L.
• Absolute polymorphonuclear leukocyte count \>2.5\*10\^9/L.
• Platelet count \>125\*10\^9/L.
• Serum glutamic oxaloacetic transaminase (SGOT), serum glutamic pyruvic transaminase (SGPT) and total bilirubin \<2 times upper limit of normal (ULN).
• Negative for Human Immunodeficiency Virus (HIV).
• Age: Renal impairment subjects, 18-78 years. Control subjects, 35-78 years.
• Creatinine clearance measured from 24-hour urine collection (CLcr u): Renal impairment cohorts, Mild Impairment (CLcr u = 51-80 ml/min), Moderate Impairment (CLcr u = 31-50 ml/min), and Severe Impairment (CLcr u \<31 ml/min, not requiring dialysis). Control subjects, CLcr u \>90 ml/min.

You may not qualify if:

• Known sensitivity to plerixafor or any of its components.
• Pregnant or breast-feeding.
• Actual body weight exceeds 175% of ideal body mass index.
• Subjects judged by the investigator to be at significant risk of failing to comply with the requirements of the protocol.
• Any subject who has started new medication within 14 days prior to study drug administration.
• Treatment with an investigational product within 30 days prior to trial entry.
• Any significant untreated or newly diagnosed medical condition other than renal impairment that in the opinion of the investigator may interfere with the conduct of the study.
• History of clinically significant thrombocytopenia.
• Received blood transfusions within 30 days prior to trial entry.
• Active malignant/neoplastic disease requiring treatment of any kind.
• Active infection requiring antibiotics
• Renal impairment requiring any method of dialysis
• History of kidney transplant
• Subjects having clinical status or laboratory parameter deterioration between the time of enrollment and dosing with plerixafor (such that they no longer meet entry criteria) may be removed from the study at the discretion of the treating physician, principal investigator, or sponsor.

Sponsors & Collaborators

• Genzyme, a Sanofi Company: lead

Study Sites (3)

Apex Research of Riverside

Santa Ana, California, 92705, United States

Location

Prism Research, 1000 Westgate Dr. suite 149

Saint Paul, Minnesota, 55114, United States

Location

Creighton University Medical Center

Omaha, Nebraska, 68131, United States

Location

MeSH Terms

Conditions

Renal Insufficiency

Interventions

plerixafor

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Genzyme Medical Information
• Organization: Genzyme Corporation

1-800-745-4447

Study Officials

• Medical Monitor

  Genzyme, a Sanofi Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 7, 2007
• First Posted: March 8, 2007
• Study Start: January 1, 2006
• Primary Completion: August 1, 2007
• Study Completion: August 1, 2007
• Last Updated: March 13, 2014
• Results First Posted: January 12, 2011

Record last verified: 2014-02

Locations

US (3)