Dexpramipexole Japanese PK Study

• Status: Completed
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: All

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 subjects.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Knopp Biosciences
• Collaborator: Biogen
• Treatments: Pramipexole

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.