Safety, Pharmacokinetics (PK), And Hematological Activity Of AMD3100 (Plerixafor) In Subjects With Renal Impairment
Condition: Renal Impairment
MeSH terms: Renal Insufficiency
Intervention: plerixafor
Intervention description: Single dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection
Intervention MeSH terms: Plerixafor
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Maximum age: 78 Years
Healthy volunteers: No
Keywords: AMD3100

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.
    

Eligibility 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.

          -  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.

        Exclusion Criteria:

          -  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.

          -  Abnormal electrocardiogram 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 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.