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Dexpramipexole SAD/MAD Study

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ClinicalTrials.gov Identifier: NCT01449578
Recruitment Status : Completed
First Posted : October 10, 2011
Last Update Posted : November 25, 2014
Sponsor:
Information provided by (Responsible Party):
Knopp Biosciences

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Drug: Dexpramipexole Drug: Dexpramipexole Placebo Phase 1

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Blinded, Placebo-Controlled Ascending Dose Study of the Safety and Pharmacokinetics of Dexpramipexole in Healthy Volunteers
Study Start Date : November 2011
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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. ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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
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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): NCT01449578


Locations
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United States, Kansas
Research Site
Overland Park, Kansas, United States
Sponsors and Collaborators
Knopp Biosciences
More Information
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Responsible Party: Knopp Biosciences
ClinicalTrials.gov Identifier: NCT01449578    
Other Study ID Numbers: 223HV103
First Posted: October 10, 2011    Key Record Dates
Last Update Posted: November 25, 2014
Last Verified: November 2014
Additional relevant MeSH terms:
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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