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Dexpramipexole Japanese PK Study

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ClinicalTrials.gov Identifier: NCT01424163
Recruitment Status : Completed
First Posted : August 26, 2011
Last Update Posted : November 25, 2014
Sponsor:
Collaborator:
Biogen
Information provided by (Responsible Party):
Knopp Biosciences

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.

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Drug: Single dose reduced Drug: Single dose standard Drug: Multiple Dose Phase 1

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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 Start Date : August 2011
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012


Arm Intervention/treatment
Experimental: Treatment 1 (Part A)
Dexpramipexole single dose (reduced dose)
Drug: Single dose reduced
Treatment 1 (Part A)
Experimental: Treatment 2 (Part A)
Dexpramipexole single dose (Standard dose)
Drug: Single dose standard
Treatment 2 (Part A)
Experimental: Treatment 3 (Part A)
Dexpramipexole multiple dosing
Drug: Multiple Dose
Treatment 3 (Part A)
Experimental: Treatment for Part B
Dexpramipexole multiple dosing
Drug: Multiple Dose
Part B



Primary Outcome Measures :
  1. 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. ]
  2. 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. ]

Secondary Outcome Measures :
  1. 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) ]
  2. 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) ]
  3. 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) ]
  4. 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) ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01424163


Locations
United Kingdom
Research Site
London, United Kingdom
Sponsors and Collaborators
Knopp Biosciences
Biogen

Responsible Party: Knopp Biosciences
ClinicalTrials.gov Identifier: NCT01424163     History of Changes
Other Study ID Numbers: 223HV101
First Posted: August 26, 2011    Key Record Dates
Last Update Posted: November 25, 2014
Last Verified: November 2014

Additional relevant MeSH terms:
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Pramipexole
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents