Dexpramipexole Japanese PK Study

• Register: ClinicalTrials.gov
• Last refreshed on: 28 June 2021
• Main ID: NCT01424163
• Date of registration: 28/07/2011
• Prospective Registration: Yes
• Primary sponsor: Knopp Biosciences
• Public title: Dexpramipexole Japanese PK Study
• Scientific title: A Single and Multiple Dose, Open-Label Study of the Pharmacokinetics, Safety, and Tolerability of Dexpramipexole (BIIB050) in Healthy Japanese and Caucasian Subjects
• Date of first enrolment: August 2011
• Target sample size: 57
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01424163
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Crossover Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

United Kingdom

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 60 Years
Gender: All

Health Condition(s) or Problem(s) studied

Amyotrophic Lateral Sclerosis

Intervention(s)

Drug: Multiple Dose

Drug: Single dose standard

Drug: Single dose reduced

Primary Outcome(s)

AUC of dexpramipexole [Time Frame: pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours after dosing on Days 1 and 5 in Treatments 1 and 2, and after the fifth dose on Day 11 in Treatment 3 for Parts A & B.]

Cmax of dexpramipexole [Time Frame: pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours after dosing on Days 1 and 5 in Treatments 1 and 2, and after the fifth dose on Day 11 in Treatment 3 for Parts A & B.]

Secondary Outcome(s)

ECG changes [Time Frame: pre-dose to 72 hrs post-dose in each dose group and again at follow-up (14 hrs post last dose)]

Vital Sign changes [Time Frame: pre-dose to 72 hrs post-dose in each dose group and again at follow-up (14 hrs post last dose)]

Adverse Event monitoring [Time Frame: pre-dose to 72 hrs post-dose in each dose group and again at follow-up (14 hrs post last dose)]

Changes in clinical laboratory tests [Time Frame: pre-dose to 72 hrs post-dose in each dose group and again at follow-up (14 hrs post last dose)]

Secondary ID(s)

223HV101

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Biogen