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Dexpramipexole Japanese PK Study

NCT01424163 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2021-06-22

No results posted yet for this study

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

Interventions

DRUG

Single dose reduced

Treatment 1 (Part A)

DRUG

Single dose standard

Treatment 2 (Part A)

DRUG

Multiple Dose

Treatment 3 (Part A)

DRUG

Multiple Dose

Part B

Sponsors & Collaborators

  • Biogen

    collaborator INDUSTRY

  • Knopp Biosciences

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2012-02-29
Completion
2012-02-29

Countries

  • United Kingdom

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01424163 on ClinicalTrials.gov