Dexpramipexole Japanese PK Study

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:

A Single and Multiple Dose, Open-Label Study of the Pharmacokinetics, Safety, and Tolerability of Dexpramipexole (BIIB050) in Healthy Japanese and Caucasian Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01424163
• Other study ID #: 223HV101
• Status: Completed
• Phase: Phase 1
• Start date: August 2011
• Est. completion date: February 2012

Study information

• Verified date: November 2014
• Source: Knopp Biosciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 dosing) and will remain in the clinical unit under observation until discharge. All subjects will have a final follow up visit. Whilst resident in the clinic, subjects will receive 4 treatments: The first 3 treatments comprise Part A of the study and the final treatment group comprises Part B.

Part A:

Treatment 1: Dose 1 (reduced) of dexpramipexole; a single dose Treatment 2: Dose 2 (standard) dexpramipexole; a single dose Treatment 3: Dose 3 (standard) dexpramipexole; 5 doses administered at 12 hour intervals Part B: Dose 4 (standard) dexpramipexole; 5 doses administered at 12 hour intervals There will be a minimum washout of 3 days between treatments.

For all subjects, prior to proceeding to the next treatment group, safety and tolerability data will be reviewed.

Caucasian subjects will be matched individually (on a 1:1 basis) to Japanese subjects with respect to gender and age and if possible BMI.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease

Intervention

Drug:
• Single dose reduced
Treatment 1 (Part A)
• Single dose standard
Treatment 2 (Part A)
• Multiple Dose
Treatment 3 (Part A)
• Multiple Dose
Part B

Locations

Country	Name	City	State
United Kingdom	Research Site	London

Sponsors (2)

Lead Sponsor	Collaborator
Knopp Biosciences	Biogen

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax of dexpramipexole		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.
Primary	AUC of dexpramipexole		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	Changes in clinical laboratory tests		pre-dose to 72 hrs post-dose in each dose group and again at follow-up (14 hrs post last dose)
Secondary	ECG changes		pre-dose to 72 hrs post-dose in each dose group and again at follow-up (14 hrs post last dose)
Secondary	Vital Sign changes		pre-dose to 72 hrs post-dose in each dose group and again at follow-up (14 hrs post last dose)
Secondary	Adverse Event monitoring		pre-dose to 72 hrs post-dose in each dose group and again at follow-up (14 hrs post last dose)