Dexpramipexole Renal PK Study

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01424176
• Date of registration: 23/06/2011
• Prospective Registration: Yes
• Primary sponsor: Knopp Biosciences
• Public title: Dexpramipexole Renal PK Study
• Scientific title: A Multicenter, Open-Label, Single-dose, Pharmacokinetic and Safety Study of Dexpramipexole (BIIB050) in Healthy Subjects and Subjects With Renal Impairment
• Date of first enrolment: July 2011
• Target sample size: 36
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01424176
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
• Phase: Phase 1

Countries of recruitment

United States

Key inclusion & exclusion criteria

Inclusion Criteria:

- Adult males/females aged 18 to 75 years inclusive and between 19 and 36 kg/m2
inclusive BMI.

- Subjects with renal impairment must have stable renal disease (i.e., no change in
disease status within the 28 days prior to dosing) as determined by the Investigator
with laboratory and clinical findings that support the diagnosis of renal impairment.

- Subjects with renal impairment (excluding ESRD subjects), must have 2 separate
estimates of creatinine clearance that are within 25% of each other, obtained >5 days
apart, but not >6 months apart

- Subjects must have a GFR (estimated GFR; as defined by estimation of creatinine
clearance using the MDRD formula) of =80 (healthy volunteers), between 50 and 79
(mild renal impairment), between 30 and 49 (moderate renal impairment), or <30
(severe renal impairment), or must require dialysis =3 times a week (ESRD).

- Healthy volunteers must be matched to renally impaired subjects for age (± 10 years),
gender, and if possible BMI (± 20%).

Exclusion Criteria:

- Healthy volunteers who have received prescription medication within the 14 days prior
to dosing (except for birth control).

- Renally impaired subjects who have received prescription medication within the 14
days prior to dosing (except for birth control and medications taken at a stable dose
for underlying conditions, as determined by the Investigator).



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Amyotrophic Lateral Sclerosis

Renal Insufficiency

Intervention(s)

Drug: Dexpramipexole (dose 1)

Drug: Dexpramipexole (dose 2)

Primary Outcome(s)

Cmax after single dose of dexpramipexole [Time Frame: pre dose and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours after dosing in all subjects, and in addition at 96, 120, and 144 hours after dosing in subjects with severe renal impairment and ESRD.]

AUC after single dose of dexpramipexole [Time Frame: pre dose and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours after dosing in all subjects, and in addition at 96, 120, and 144 hours after dosing in subjects with severe renal impairment and ESRD.]

Secondary Outcome(s)

Vital Sign monitoring [Time Frame: pre-144 hrs post dose]

ECG Monitoring [Time Frame: pre-144 hrs post dose]

AE monitoring [Time Frame: pre-144 hrs post dose]

Mointoring of Clinical Laboratory tests [Time Frame: pre-144 hours post dose]

Secondary ID(s)

223RI101

Source(s) of Monetary Support

Please refer to primary and secondary sponsors