Dexpramipexole Japanese PK Study

NCT01424163 | Completed Phase 1

• 1 other identifier: 223HV101
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Amyotrophic Lateral Sclerosis

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (4)

• 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)

• ECG changes

  pre-dose to 72 hrs post-dose in each dose group and again at follow-up (14 hrs post last dose)

• Vital Sign changes

  pre-dose to 72 hrs post-dose in each dose group and again at follow-up (14 hrs post last dose)

• Adverse Event monitoring

  pre-dose to 72 hrs post-dose in each dose group and again at follow-up (14 hrs post last dose)

Study Arms (4)

Treatment 1 (Part A)

EXPERIMENTAL

Dexpramipexole single dose (reduced dose)

Drug: Single dose reduced

Treatment 2 (Part A)

EXPERIMENTAL

Dexpramipexole single dose (Standard dose)

Drug: Single dose standard

Treatment 3 (Part A)

EXPERIMENTAL

Dexpramipexole multiple dosing

Drug: Multiple Dose

Treatment for Part B

EXPERIMENTAL

Dexpramipexole multiple dosing

Drug: Multiple Dose

Interventions

Single dose reduced DRUG

Treatment 1 (Part A)

Treatment 1 (Part A)

Single dose standard DRUG

Treatment 2 (Part A)

Treatment 2 (Part A)

Multiple Dose DRUG

Treatment 3 (Part A)

Treatment 3 (Part A)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Knopp Biosciences: lead
• Biogen: collaborator

Study Sites (1)

Research Site

London, United Kingdom

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2011
• First Posted: August 26, 2011
• Study Start: August 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: June 22, 2021

Record last verified: 2014-11

Locations

GB (1)