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
Results First Received: August 24, 2012  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Basic Science
Condition: Renal Insufficiency
Intervention: Drug: Dalfampridine-ER

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
First subject screened January, 2011. Last subject out August, 2011. Full Service Phase 1 Units.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Healthy: Dalfampridine-ER 7.5 mg

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

Dalfampridine-ER : 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

Dalfampridine-ER : 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

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


Participant Flow:   Overall Study
    Healthy: Dalfampridine-ER 7.5 mg     Mild Renal: Dalfampridine-ER 7.5 mg     Moderate Renal: Dalfampridine-ER 7.5 mg  
STARTED     13     17     12  
COMPLETED     12     17     12  
NOT COMPLETED     1     0     0  
Lost to Follow-up                 1                 0                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Healthy: Dalfampridine-ER 7.5 mg

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

Dalfampridine-ER : 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

Dalfampridine-ER : 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

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

Total Total of all reporting groups

Baseline Measures
    Healthy: Dalfampridine-ER 7.5 mg     Mild Renal: Dalfampridine-ER 7.5 mg     Moderate Renal: Dalfampridine-ER 7.5 mg     Total  
Number of Participants  
[units: participants]
  13     17     12     42  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     11     10     2     23  
>=65 years     2     7     10     19  
Age  
[units: years]
Mean ± Standard Deviation
  41.9  ± 14.65     63.2  ± 7.22     67.1  ± 7.65     57.7  ± 14.71  
Gender  
[units: participants]
       
Female     3     7     4     14  
Male     10     10     8     28  
Race/Ethnicity, Customized  
[units: participants]
       
Asian     0     4     2     6  
Black or African American     1     2     2     5  
White     11     11     8     30  
Other     1     0     0     1  



  Outcome Measures
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1.  Primary:   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 ]

2.  Secondary:   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 ]

3.  Secondary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Herbert Henney, PharmD
Organization: Vice President - Clinical Development & Medical Affairs (CDMA)
phone: (914) 347-4300 ext 5138
e-mail: hhenney@acorda.com


No publications provided


Responsible Party: Acorda Therapeutics
ClinicalTrials.gov Identifier: NCT01316055     History of Changes
Other Study ID Numbers: RD7.5D-ER012010
Study First Received: March 14, 2011
Results First Received: August 24, 2012
Last Updated: October 9, 2012
Health Authority: United States: Food and Drug Administration