Dexpramipexole Japanese PK Study

This study has been completed.
Sponsor:
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01424163
First received: July 28, 2011
Last updated: July 19, 2012
Last verified: July 2012
  Purpose

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 Intervention Phase
Amyotrophic Lateral Sclerosis
Drug: Single dose reduced
Drug: Single dose standard
Drug: Multiple Dose
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]
  • 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) ] [ Designated as safety issue: Yes ]
  • 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) ] [ Designated as safety issue: Yes ]
  • 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) ] [ Designated as safety issue: Yes ]

Enrollment: 56
Study Start Date: August 2011
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01424163

Locations
United Kingdom
Research Site
London, United Kingdom
Sponsors and Collaborators
Biogen Idec
  More Information

No publications provided

Responsible Party: Biogen Idec Medical Director, Biogen Idec, Ltd.
ClinicalTrials.gov Identifier: NCT01424163     History of Changes
Other Study ID Numbers: 223HV101
Study First Received: July 28, 2011
Last Updated: July 19, 2012
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

ClinicalTrials.gov processed this record on August 21, 2014