Pharmacokinetics (PK) of Dalfampridine-ER 7.5 mg BID in Healthy Volunteers and Subjects With Mild or Moderate Renal Impairment

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Acorda Therapeutics
ClinicalTrials.gov Identifier:
NCT01316055
First received: March 14, 2011
Last updated: October 9, 2012
Last verified: October 2012

March 14, 2011
October 9, 2012
January 2011
August 2011   (final data collection date for primary outcome measure)
The Steady State Area Under the Drug Concentration Time Curve From 0 to 12 Hours Post Dose AUC(0-12). [ Time Frame: 0 and 1,2,3,4,5,6,8, and 12 hours after the last dose ] [ Designated as safety issue: Yes ]
AUC(0-12) was based on blood samples taken at specified outcome measure time frame for dalfampridine-ER 7.5 mg tablets in healthy adult volunteers and people with mild or moderate renal impairment.
To characterize the steady-state pharmacokinetics of Dalfampridine-ER 7.5 mg tablets in healthy adults and people with mild and moderate renal impairment and to examine between group differences [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
pharmacokinetics of 7.5 mg dalfampridine-ER
Complete list of historical versions of study NCT01316055 on ClinicalTrials.gov Archive Site
  • The Maximum Measured Plasma Concentration (Cmax) at Steady State, of Dalfampridine-ER 7.5 mg Tablets in Healthy Adult Volunteers and Those With Mild and Moderate Renal Impairment and Examine Between-group Differences. [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
  • The Steady State Fractional Clearance, Calculated as the Dose / AUC(0-12) (CL/Fss) of Dalfampridine-ER 7.5 mg Tablets in Healthy Adult Volunteers and Those With Mild and Moderate Renal Impairment and Examine Between-group Differences. [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
To characterize the single dose pharmacokinetics of Dalfampridine-ER 7.5 mg tablets in healthy adult volunteers and those with mild and moderate renal impairment and examine between-group differences. [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Pharmacokinetics (PK) of Dalfampridine-ER 7.5 mg BID in Healthy Volunteers and Subjects With Mild or Moderate Renal Impairment
A Parallel, Three Arm, Open-label, Multi-dose Pharmacokinetic Study of Dalfampridine-ER 7.5 mg Twice Daily in Both Healthy Volunteers and Those With Mild and Moderate Renal Impairment

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.

Pharmacokinetics in normal, mildly renally impaired, and moderately renally impaired subjects

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Renal Insufficiency
Drug: Dalfampridine-ER
2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up
  • Active Comparator: Healthy: Dalfampridine-ER 7.5 mg
    Dalfampridine-ER 7.5 mg single and steady-state dosing in healthy volunteers
    Intervention: Drug: Dalfampridine-ER
  • Active Comparator: Mild renal: Dalfampridine-ER 7.5 mg
    Dalfampridine-ER 7.5 mg single and steady-state dosing in volunteers with mild renal impairment
    Intervention: Drug: Dalfampridine-ER
  • Active Comparator: Moderate renal: Dalfampridine-ER 7.5 mg
    Dalfampridine-ER 7.5 mg single and steady-state dosing in volunteers with moderate renal impairment
    Intervention: Drug: Dalfampridine-ER
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
September 2011
August 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01316055
RD7.5D-ER012010
No
Acorda Therapeutics
Acorda Therapeutics
Not Provided
Study Director: Herbert R Henney, PharmD Acorda Therapeutics
Acorda Therapeutics
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP