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

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ClinicalTrials.gov Identifier: NCT01316055
Recruitment Status : Completed
First Posted : March 16, 2011
Results First Posted : November 7, 2012
Last Update Posted : November 7, 2012
Sponsor:
Information provided by (Responsible Party):
Acorda Therapeutics

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Renal Insufficiency
Intervention Drug: Dalfampridine-ER
Enrollment 42
Recruitment Details First subject screened January, 2011. Last subject out August, 2011. Full Service Phase 1 Units.
Pre-assignment Details  
Arm/Group Title Healthy: Dalfampridine-ER 7.5 mg Mild Renal: Dalfampridine-ER 7.5 mg Moderate Renal: Dalfampridine-ER 7.5 mg
Hide Arm/Group Description

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

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

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
Period Title: Overall Study
Started 13 17 12
Completed 12 17 12
Not Completed 1 0 0
Reason Not Completed
Lost to Follow-up             1             0             0
Arm/Group Title Healthy: Dalfampridine-ER 7.5 mg Mild Renal: Dalfampridine-ER 7.5 mg Moderate Renal: Dalfampridine-ER 7.5 mg Total
Hide Arm/Group Description

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

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

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 of all reporting groups
Overall Number of Baseline Participants 13 17 12 42
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 17 participants 12 participants 42 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
11
  84.6%
10
  58.8%
2
  16.7%
23
  54.8%
>=65 years
2
  15.4%
7
  41.2%
10
  83.3%
19
  45.2%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants 17 participants 12 participants 42 participants
41.9  (14.65) 63.2  (7.22) 67.1  (7.65) 57.7  (14.71)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 17 participants 12 participants 42 participants
Female
3
  23.1%
7
  41.2%
4
  33.3%
14
  33.3%
Male
10
  76.9%
10
  58.8%
8
  66.7%
28
  66.7%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 13 participants 17 participants 12 participants 42 participants
Asian 0 4 2 6
Black or African American 1 2 2 5
White 11 11 8 30
Other 1 0 0 1
1.Primary Outcome
Title The Steady State Area Under the Drug Concentration Time Curve From 0 to 12 Hours Post Dose AUC(0-12).
Hide Description 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.
Time Frame 0 and 1,2,3,4,5,6,8, and 12 hours after the last dose
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT)
Arm/Group Title Healthy: Dalfampridine-ER 7.5 mg Mild Renal: Dalfampridine-ER 7.5 mg Moderate Renal: Dalfampridine-ER 7.5 mg
Hide Arm/Group Description:

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

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

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
Overall Number of Participants Analyzed 12 17 12
Geometric Mean (90% Confidence Interval)
Unit of Measure: hour*nanogram/milliliter
157.8
(130.4 to 190.9)
276.5
(241.5 to 316.7)
415.3
(383.8 to 449.4)
2.Secondary Outcome
Title 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.
Hide Description [Not Specified]
Time Frame 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Healthy: Dalfampridine-ER 7.5 mg Mild Renal: Dalfampridine-ER 7.5 mg Moderate Renal: Dalfampridine-ER 7.5 mg
Hide Arm/Group Description:

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

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

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
Overall Number of Participants Analyzed 12 17 12
Geometric Mean (90% Confidence Interval)
Unit of Measure: nanogram/milliliter
20.61
(17.76 to 23.92)
33.92
(29.92 to 38.47)
46.69
(43.68 to 49.91)
3.Secondary Outcome
Title 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.
Hide Description [Not Specified]
Time Frame 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Healthy: Dalfampridine-ER 7.5 mg Mild Renal: Dalfampridine-ER 7.5 mg Moderate Renal: Dalfampridine-ER 7.5 mg
Hide Arm/Group Description:

Dalfampridine-ER 7.5 mg 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

Dalfampridine-ER 7.5 mg 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

Dalfampridine-ER 7.5 mg 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
Overall Number of Participants Analyzed 12 17 12
Geometric Mean (90% Confidence Interval)
Unit of Measure: liter/hour
47.54
(39.29 to 57.52)
27.12
(23.68 to 31.06)
18.06
(16.69 to 19.54)
Time Frame Total study participation was to last for approximately 7 days consisting of 2 in-clinic confinement periods (exclusive of up to 14 days of screening), and follow-up 3 days post final discharge.
Adverse Event Reporting Description All adverse events with an onset time after dosing and up to 72 hours after the last dose of study drug were considered treatment-emergent. In addition, adverse events with onset date before start of trial treatment but with worsening in intensity during the treatment period were also considered treatment-emergent.
 
Arm/Group Title Healthy: Dalfampridine-ER 7.5 mg Mild Renal: Dalfampridine-ER 7.5 mg Moderate Renal: Dalfampridine-ER 7.5 mg
Hide Arm/Group Description

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

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

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
All-Cause Mortality
Healthy: Dalfampridine-ER 7.5 mg Mild Renal: Dalfampridine-ER 7.5 mg Moderate Renal: Dalfampridine-ER 7.5 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
Healthy: Dalfampridine-ER 7.5 mg Mild Renal: Dalfampridine-ER 7.5 mg Moderate Renal: Dalfampridine-ER 7.5 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/13 (0.00%)      0/17 (0.00%)      0/12 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Healthy: Dalfampridine-ER 7.5 mg Mild Renal: Dalfampridine-ER 7.5 mg Moderate Renal: Dalfampridine-ER 7.5 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/13 (61.54%)      8/17 (47.06%)      4/12 (33.33%)    
Blood and lymphatic system disorders       
Lymphadenitis 1  1/13 (7.69%)  1 0/17 (0.00%)  0 0/12 (0.00%)  0
Gastrointestinal disorders       
Abdominal distension 1  0/13 (0.00%)  0 1/17 (5.88%)  1 0/12 (0.00%)  0
Diarrhoea 1  1/13 (7.69%)  1 0/17 (0.00%)  0 1/12 (8.33%)  1
Frequent bowel movements 1  0/13 (0.00%)  0 1/17 (5.88%)  1 0/12 (0.00%)  0
General disorders       
Any TEAEs (treatment emergent adverse effects) 1  8/13 (61.54%)  10 8/17 (47.06%)  10 4/12 (33.33%)  7
Investigations       
Blood creatine phosphokinase increased 1  0/13 (0.00%)  0 1/17 (5.88%)  1 0/12 (0.00%)  0
Metabolism and nutrition disorders       
Hyperglycaemia 1  1/13 (7.69%)  1 0/17 (0.00%)  0 1/12 (8.33%)  1
Hypoglycaemia 1  0/13 (0.00%)  0 0/17 (0.00%)  0 1/12 (8.33%)  2
Musculoskeletal and connective tissue disorders       
Arthralgia 1  0/13 (0.00%)  0 0/17 (0.00%)  0 2/12 (16.67%)  2
Back pain 1  1/13 (7.69%)  1 0/17 (0.00%)  0 0/12 (0.00%)  0
Muscular weakness 1  1/13 (7.69%)  1 0/17 (0.00%)  0 0/12 (0.00%)  0
Myalgia 1  0/13 (0.00%)  0 1/17 (5.88%)  1 0/12 (0.00%)  0
Neck pain 1  0/13 (0.00%)  0 1/17 (5.88%)  1 0/12 (0.00%)  0
Nervous system disorders       
Dizziness 1  2/13 (15.38%)  2 1/17 (5.88%)  1 1/12 (8.33%)  1
Headache 1  2/13 (15.38%)  2 3/17 (17.65%)  3 0/12 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Dyspnoea 1  1/13 (7.69%)  1 0/17 (0.00%)  0 0/12 (0.00%)  0
Vascular disorders       
Hypertension 1  0/13 (0.00%)  0 1/17 (5.88%)  1 0/12 (0.00%)  0
1
Term from vocabulary, MedDRA 13.1
[Not Specified]
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.
Sponsor (Acorda) has right to review and comment on proposed publications within a specified time frame, up to 60 days; multi-center trials require joint publication unless specifically permitted otherwise.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Herbert Henney, PharmD
Organization: Vice President - Clinical Development & Medical Affairs (CDMA)
Phone: (914) 347-4300 ext 5138
EMail: hhenney@acorda.com
Layout table for additonal information
Responsible Party: Acorda Therapeutics
ClinicalTrials.gov Identifier: NCT01316055    
Other Study ID Numbers: RD7.5D-ER012010
First Submitted: March 14, 2011
First Posted: March 16, 2011
Results First Submitted: August 24, 2012
Results First Posted: November 7, 2012
Last Update Posted: November 7, 2012