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

NCT ID: NCT01316055

Last Updated: 2012-11-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2011-09-30

Brief 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.

Detailed Description

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

Conditions

Renal Insufficiency

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Healthy: Dalfampridine-ER 7.5 mg

Dalfampridine-ER 7.5 mg single and steady-state dosing in healthy volunteers

Group Type: ACTIVE_COMPARATOR

Dalfampridine-ER

Intervention Type: DRUG

2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up

Mild renal: Dalfampridine-ER 7.5 mg

Dalfampridine-ER 7.5 mg single and steady-state dosing in volunteers with mild renal impairment

Group Type: ACTIVE_COMPARATOR

Dalfampridine-ER

Intervention Type: DRUG

2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up

Moderate renal: Dalfampridine-ER 7.5 mg

Dalfampridine-ER 7.5 mg single and steady-state dosing in volunteers with moderate renal impairment

Group Type: ACTIVE_COMPARATOR

Dalfampridine-ER

Intervention Type: DRUG

2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up

Interventions

Dalfampridine-ER

2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Acorda Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Herbert R Henney, PharmD

Role: STUDY_DIRECTOR

Acorda Therapeutics

Locations

ACRI - Phase 1

Anaheim, California, United States

MRA Clinical Research

South Miami, Florida, United States

Countries

United States

Other Identifiers

RD7.5D-ER012010

Identifier Type: -

Identifier Source: org_study_id