Safety, PK, And Hematological Activity Of AMD3100 In Subjects With Renal Impairment - Full Text View

Sponsored by:	Genzyme
Information provided by:	Genzyme
ClinicalTrials.gov Identifier:	NCT00445302

Purpose

Eligible male and female subjects with renal impairment (aged 18-78 years) and healthy control subjects (aged in the upper age range of the renal impairment subjects) 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 14 days prior to AMD3100 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 AMD3100 administration for blood samples and safety assessments.

Condition	Intervention	Phase
Renal Impairment	Drug: AMD3100	Phase I

Drug Information available for: JM 3100

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase I Study Of The Safety, Pharmacokinetics, And Hematological Activity Of AMD3100 (240 µg/kg) In Subjects With Renal Impairment

Further study details as provided by Genzyme:

Primary Outcome Measures:

To determine the effects of impaired renal function on the pharmacokinetics of 240 μg/kg SC dose of AMD3100.

Secondary Outcome Measures:

To determine whether impaired renal function alters the hematological effect of a 240 µg/kg SC dose of AMD3100 on circulating WBCs and CD34+ cells and whether this effect is independent of changes in AMD3100 PK
to evaluate the safety of a 240µg/kg subcutaneous dose of AMD3100 administered to subjects with renal impairment.

Estimated Enrollment:	18
Study Start Date:	January 2006
Study Completion Date:	August 2007

Detailed Description:

This is a phase I, open label, multi-center study in which up to eighteen subjects with renal impairment and six healthy control subjects with normal renal function will receive a single dose of AMD3100 (240 µg/kg) administered by subcutaneous (SC) injection.

Eligible male and female subjects with renal impairment (aged 18-78 years) and healthy control subjects (aged in the upper age range of the renal impairment subjects) will be enrolled in the study. Subjects with renal impairment will be enrolled and stratified into three cohorts using their Screening 24 hour urine collection to measured creatinine clearance (CLcr) values (an estimate of Glomerular Filtration Rate): Mild Impairment (CLcr = 51-80 ml/min), Moderate Impairment (CLcr = 31-50 ml/min), and Severe Impairment (CLcr <31 ml/min, not requiring dialysis). Control subjects will have normal renal function (CLcr >90 ml/min), as determined by a Screening 24 hour urine collection.

The screening visits will occur 14 days prior to AMD3100 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 AMD3100 administration for blood samples and safety assessments.

Eligibility

Ages Eligible for Study:	18 Years to 78 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.
WBC ≧3.5 x 10e9/L.
Absolute PMN count >2.5 x 10e9/L.
PLT count >125 x 10e9/L.
SGOT, SGPT, and total bilirubin <2x upper limit of normal.
Negative for HIV.
Age: Renal impairment subjects, 18-78 years. Control subjects, 35-78 years.
CLcr: Renal impairment cohorts, Mild Impairment (CLcr = 51-80 ml/min), Moderate Impairment (CLcr = 31-50 ml/min), and Severe Impairment (CLcr <31 ml/min, not requiring dialysis). Control subjects, CLcr >90 ml/min.

Exclusion Criteria:

Known sensitivity to AMD3100 or any of its components.
Pregnant or breast-feeding.
Actual body weight exceeds 175% of ideal body BMI.
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.
Abnormal ECG with clinically significant rhythm disturbance,(ventricular arrhythmias), or other conduction abnormality that in the opinion of the investigator warrants exclusion of the subject from the trial.
History of clinically significant thrombocytopenia.
Received blood transfusions within 30 days prior to trial entry.
Any subject who requires therapeutic intervention within the 30 days prior to administration of study medication in order to meet the inclusion/exclusion criteria.
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 enrolment and dosing with AMD3100 (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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00445302

Locations

United States, California
Apex Research of Riverside
Santa Ana, California, United States, 92705
United States, Nebraska
Creighton University Medical Center
OMAHA, Nebraska, United States, 68131

Sponsors and Collaborators

Genzyme

More Information

No publications provided

Study ID Numbers:	AMD31001101
Study First Received:	March 7, 2007
Last Updated:	June 6, 2008
ClinicalTrials.gov Identifier:	NCT00445302 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Genzyme:

AMD3100

Study placed in the following topic categories:

Anti-HIV Agents
Anti-Retroviral Agents
JM 3100
Antiviral Agents

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-HIV Agents
Anti-Retroviral Agents
JM 3100

Therapeutic Uses
Antiviral Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 06, 2009