Dexpramipexole SAD/MAD Study

This study has been completed.
Sponsor:
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01449578
First received: September 22, 2011
Last updated: January 26, 2012
Last verified: January 2012
  Purpose

This Phase 1 study will explore the safety, tolerability, and pharmacokinetics of single doses ranging from 300 to 600 mg and multiple daily doses ranging from 225 mg to 300 mg BID dexpramipexole in healthy volunteers.


Condition Intervention Phase
Amyotrophic Lateral Sclerosis
Drug: Dexpramipexole
Drug: Dexpramipexole Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Blinded, Placebo-Controlled Ascending Dose Study of the Safety and Pharmacokinetics of Dexpramipexole in Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • Safety and tolerability based on medical review of adverse events & results of vital sign measurements, electrocardiogram (ECGs), physical examinations and clinical laboratory tests. [ Time Frame: Change from baseline to 11 Days. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Dexpramipexole pharmacokinetics time frame in plasma [ Time Frame: pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours post-dose ] [ Designated as safety issue: No ]

Enrollment: 63
Study Start Date: November 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Part A, Treatment 1
Dexpramipexole single dose (SAD Dose 1)
Drug: Dexpramipexole
Oral Tablet at varying doses
Other Name: BIIB050
Placebo Comparator: Part A, Treatment 1 placebo
Dexpramipexole single dose placebo (SAD Dose 1)
Drug: Dexpramipexole Placebo
Oral tablet at varying doses
Experimental: Part A, Treatment 2
Dexpramipexole single dose (SAD Dose 2)
Drug: Dexpramipexole
Oral Tablet at varying doses
Other Name: BIIB050
Placebo Comparator: Part A, Treatment 2 placebo
Dexpramipexole single dose placebo (SAD Dose 2)
Drug: Dexpramipexole Placebo
Oral tablet at varying doses
Experimental: Part A, Treatment 3
Dexpramipexole single dose (SAD Dose 3)
Drug: Dexpramipexole
Oral Tablet at varying doses
Other Name: BIIB050
Placebo Comparator: Part A, Treatment 3 placebo
Dexpramipexole single dose placebo (SAD Dose 3)
Drug: Dexpramipexole Placebo
Oral tablet at varying doses
Experimental: Part B, Treatment 1
Dexpramipexole multiple dose (MAD Dose 1)
Drug: Dexpramipexole
Oral Tablet at varying doses
Other Name: BIIB050
Placebo Comparator: Part B, Treatment 1 placebo
Dexpramipexole multiple dose placebo (MAD Dose 1)
Drug: Dexpramipexole Placebo
Oral tablet at varying doses
Experimental: Part B, Treatment 2
Dexpramipexole multiple dose (MAD Dose 2)
Drug: Dexpramipexole
Oral Tablet at varying doses
Other Name: BIIB050
Placebo Comparator: Part B, Treatment 2 placebo
Dexpramipexole multiple dose placebo (MAD Dose 2)
Drug: Dexpramipexole Placebo
Oral tablet at varying doses

Detailed Description:

Preclinical and clinical data to date support the exploration of doses of dexpramipexole higher than 150 mg twice daily for their effectiveness in slowing the progression of ALS. Exploration of doses of dexpramipexole higher than 150 mg twice daily is justified by preclinical and clinical data that suggest that higher doses could potentially be more effective in slowing the progression of ALS than the dose of dexpramipexole currently being explored in Phase 3 studies (150 mg twice daily).

This is a Phase 1, single-center, blinded, randomized, placebo controlled, ascending-dose study consisting of 2 parts; Part A (single-ascending dose [SAD]) and Part B (multiple ascending dose [MAD]). The study will explore safety, tolerability, and pharmacokinetics of single doses ranging from 300 to 600 mg and multiple daily doses ranging from 225 mg to 300 mg BID dexpramipexole in healthy volunteers.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Must give written informed consent.
  • Adult males/females aged 18 to 55 years inclusive and between 19 and 30 kg/m2 body mass index (BMI), inclusive at screening.
  • Subjects who are healthy as determined by prestudy medical history, physical examination and 12-lead ECG.
  • 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.
  • Normal systemic blood pressure defined as a systolic blood pressure of 90 to 140 mmHg and a diastolic blood pressure of 50 to 90 mmHg.

Exclusion Criteria:

  • History of cardiovascular disease (e.g., hypertension, arrhythmia, heart failure, Long QT Syndrome, or other conditions/diseases causing prolongation of the QT/QTc interval).
  • A prolongation of QT/QTc interval (e.g., repeated demonstration of a QT/QTc interval >450 ms before study treatment administration) at screening, admission or pre-dose on Day 1.
  • Any clinically important abnormalities in resting ECG that may interfere with the interpretation of QTc interval changes at screening, admission or pre-dose on Day 1.
  • Prior exposure to dexpramipexole.
  • Treatment with pramipexole or any dopamine agonist within 1 year.
  • Treatment with another investigational drug or approved therapy for investigational use within 30 days, or 5 half-lives (whichever is longer), or in follow up for any other drug, biologic, or device study.
  • Currently active infection or serious infection (e.g., pneumonia, septicemia) within the 2 months prior to Day -2 as determined by the Investigator.
  • Female subjects who are pregnant, currently breastfeeding, or attempting to conceive during the study.
  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: NCT01449578

Locations
United States, Kansas
Research Site
Overland Park, Kansas, United States
Sponsors and Collaborators
Biogen Idec
  More Information

No publications provided

Responsible Party: Biogen Idec Medical Director, Biogen Idec, Inc.
ClinicalTrials.gov Identifier: NCT01449578     History of Changes
Other Study ID Numbers: 223HV103
Study First Received: September 22, 2011
Last Updated: January 26, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Amyotrophic Lateral Sclerosis
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Motor Neuron Disease
Neurodegenerative Diseases
TDP-43 Proteinopathies
Neuromuscular Diseases
Proteostasis Deficiencies
Metabolic Diseases
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 September 18, 2014