Pharmacokinetics (PK) of Dalfampridine-ER 7.5 mg BID in Healthy Volunteers and Subjects With Mild or Moderate Renal Impairment
Condition: Renal Insufficiency
MeSH terms: Renal Insufficiency
Intervention: Dalfampridine-ER
Intervention description: 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up
Intervention MeSH terms: 4-Aminopyridine
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 42.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The steady-state pharmacokinetics of Dalfampridine-ER (extended release) 7.5 mg (milligram)
      tablets in healthy adult volunteers and those with mild and moderate renal impairment, and
      examine between group comparisons.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Either gender between the ages of 18 and 75 years

          -  Have a body mass index (BMI) ranging between 18.5 - 35.0 kg/m2, inclusive

          -  Have adequate cognitive function to understand and sign the IRB approved informed
             consent prior to the performance of any study-specific procedures

          -  Be willing and able to comply with all trial requirements

          -  Fit into one of three 12-subject groups: normal renal function (CrCl > 80 mL/min),
             mild renal impairment (CrCl 51-80 mL/min), and moderate renal impairment (CrCl 30-50
             mL/min)

          -  Have sufficient venous access to permit blood sample collection

          -  Women of childbearing potential must have a negative β-HCG pregnancy test at the
             Screening Visit.

        Exclusion Criteria:

          -  Women who are either pregnant or breastfeeding, and women of childbearing potential
             (i.e., has not had a hysterectomy or bilateral oophorectomy, or is not at least two
             years postmenopausal) who are engaged in active heterosexual relations and not using
             any of the following birth control methods: tubal ligation, implantable contraception
             device, oral, patch or injectible contraceptive, double barrier method, or sexual
             activity restricted to a vasectomized partner;

          -  History of seizure(s);

          -  Unstable, acute, or severe (CrCl < 30 mL/min) renal failure;

          -  Clinically significant abnormal findings on the physical examination, ECG, vital
             signs, medical history, or clinical laboratory results during screening (other than
             abnormal renal values);

          -  Any unstable cardiovascular, enterohepatic, respiratory, or immunologic disorder or
             disease that may substantially affect the pharmacokinetics of Dalfampridine-ER;

          -  Known allergy to pyridine-containing substances, or any of the inactive ingredients of
             the Dalfampridine-ER tablet (colloidal silicon dioxide, hydroxypropyl methylcellulose,
             magnesium stearate, microcrystalline cellulose, polyethylene glycol, and titanium
             dioxide);

          -  Participation in an investigational drug trial 30 days prior to Screening or plans to
             enroll in an investigational drug trial at any time during this study;

          -  Any medical condition including psychiatric disease that would interfere with the
             interpretation of the study results or the conduct of the study;

          -  Subject has started a new medication (prescription, vitamins, herbal medications, or
             other over-the-counter medications), or had a change in their existing medication
             within 30 days prior to screening;

          -  History of drug or alcohol abuse in the past 2 years, or tests positive for drugs of
             abuse at Screening;

          -  Donation of blood or blood components within 30 days prior to administration of
             investigational drug. The Investigator should instruct subjects who participate in
             this study not to donate blood or blood components during their participation in the
             study and up to four weeks after the completion of the study.