Status:
COMPLETED
Dexpramipexole Japanese PK Study
Lead Sponsor:
Knopp Biosciences
Collaborating Sponsors:
Biogen
Conditions:
Amyotrophic Lateral Sclerosis
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
This is a single and multiple dose, open-label study to evaluate the pharmacokinetics (PK), safety, and tolerability of dexpramipexole administered orally to adult Japanese and Caucasian healthy subje...
Detailed Description
The study is designed to evaluate the influence of ethnic factors on dexpramipexole safety, tolerability, and PK. Subjects will be admitted to the clinical unit on Day -1 (the day prior to first dosin...
Eligibility Criteria
Inclusion
- Subjects who are able and willing to give written informed consent.
- Adult Japanese and Caucasian males/females aged 18 to 60 years inclusive and between 18 and 30 kg/m2 body mass index (BMI), inclusive.
- Male and female subjects will be enrolled on the study. Male subjects and female subjects of childbearing potential, must practice effective contraception during the study and be willing and able to continue contraception for 1 month (females) or 3 months (males) after their last dose of study treatment
- Japanese subjects must be born in Japan and have both parents and four grandparents of Japanese descent.
- Japanese subjects must have lived outside of Japan for no more than 5 years.
- Japanese subjects must not have significant changes with regard to diet; i.e., their diet must not have significantly changed since leaving Japan.
- Caucasian subjects will be matched individually (on a 1:1 basis) to Japanese subjects with respect to gender and age, and if possible BMI.
Exclusion
- Subjects who do not conform to the above inclusion criteria.
- Female subjects who are pregnant, trying to become pregnant or lactating.
- Subjects who have a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, connective tissue diseases or disorders.
- Subjects who have a clinically relevant surgical history.
- Subjects who have previously received dexpramipexole or pramipexole.
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT01424163
Start Date
August 1 2011
End Date
February 1 2012
Last Update
June 22 2021
Active Locations (1)
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1
Research Site
London, United Kingdom