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Dexpramipexole Japanese PK Study

Primary Purpose

Amyotrophic Lateral Sclerosis

Status

Completed

Phase

Phase 1

Locations

United Kingdom

Study Type

Interventional

Intervention

Single dose reduced

Single dose standard

Multiple Dose

About this trial

This is an interventional basic science trial for Amyotrophic Lateral Sclerosis

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Research Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Treatment 1 (Part A)

Treatment 2 (Part A)

Treatment 3 (Part A)

Treatment for Part B

Arm Description

Dexpramipexole single dose (reduced dose)

Dexpramipexole single dose (Standard dose)

Dexpramipexole multiple dosing

Outcomes

Primary Outcome Measures

Cmax of dexpramipexole

AUC of dexpramipexole

Secondary Outcome Measures

Changes in clinical laboratory tests

ECG changes

Vital Sign changes

Adverse Event monitoring

Full Information

NCT ID

NCT01424163

First Posted

July 28, 2011

Last Updated

June 16, 2021

Sponsor

Knopp Biosciences

Collaborators

Biogen

1. Study Identification

Unique Protocol Identification Number

NCT01424163

Brief Title

Dexpramipexole Japanese PK Study

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2014

Overall Recruitment Status

Completed

Study Start Date

August 2011 (undefined)

Primary Completion Date

February 2012 (Actual)

Study Completion Date

February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Knopp Biosciences

Collaborators

Biogen

4. Oversight

Data Monitoring Committee

5. Study Description

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 subjects.

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Amyotrophic Lateral Sclerosis

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

57 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment 1 (Part A)

Arm Type

Experimental

Arm Description

Dexpramipexole single dose (reduced dose)

Arm Title

Treatment 2 (Part A)

Arm Type

Experimental

Arm Description

Dexpramipexole single dose (Standard dose)

Arm Title

Treatment 3 (Part A)

Arm Type

Experimental

Arm Description

Dexpramipexole multiple dosing

Arm Title

Treatment for Part B

Arm Type

Experimental

Arm Description

Dexpramipexole multiple dosing

Intervention Type

Drug

Intervention Name(s)

Single dose reduced

Intervention Description

Treatment 1 (Part A)

Intervention Type

Drug

Intervention Name(s)

Single dose standard

Intervention Description

Treatment 2 (Part A)

Intervention Type

Drug

Intervention Name(s)

Multiple Dose

Intervention Description

Treatment 3 (Part A)

Intervention Type

Drug

Intervention Name(s)

Multiple Dose

Intervention Description

Part B

Primary Outcome Measure Information:

Title

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.

Title

AUC of dexpramipexole

Time Frame

Secondary Outcome Measure Information:

Title

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)

Title

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)

Title

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)

Title

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)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility 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.

Facility Information:

Facility Name

Research Site

City

London

Country

United Kingdom

12. IPD Sharing Statement

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Dexpramipexole Japanese PK Study

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