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Dexpramipexole and Cimetidine Drug Drug Interaction (DDI)

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ClinicalTrials.gov Identifier: NCT01536249
Recruitment Status : Completed
First Posted : February 22, 2012
Last Update Posted : November 25, 2014
Sponsor:
Information provided by (Responsible Party):
Knopp Biosciences

Brief Summary:
This study will assess the effect of cimetidine on the pharmacokinetics (PK) of dexpramipexole in healthy volunteer and evaluate the safety and tolerability of dexpramipexole when given with or without cimetidine. Additionally, this study will explore the influence of genetic variation on the PK of dexpramipexole when given with or without cimetidine.

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Drug: Dexpramipexole Drug: Cimetidine plus Dexpramipexole Phase 1

Detailed Description:

This is a single-center, open-label, randomized, two-period, crossover study in approximately 14 healthy subjects. The goals of this study are as follows:

To assess the effect of cimetidine on the pharmacokinetics (PK) of dexpramipexole in healthy volunteers.

To evaluate the safety and tolerability of dexpramipexole when given with or without cimetidine.

To explore the influence of genetic variation on the PK of dexpramipexole when given with or without cimetidine.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Study to Assess the Effect of Cimetidine on the Pharmacokinetics of Dexpramipexole (BIIB050) in Healthy Volunteers
Study Start Date : March 2012
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012


Arm Intervention/treatment
Experimental: Dexpramipexole single dose & 12 Doses Cimetidine
300 mg Dexpramipexole Oral Dose (to be taken in conjunction with multiple doses of Cimetidine at 400 mg per dose)
Drug: Cimetidine plus Dexpramipexole
Multiple Oral Doses

Experimental: Dexpramipexole single Dose
300 mg Dexpramipexole Oral Dose
Drug: Dexpramipexole
Single Oral Dose




Primary Outcome Measures :
  1. Determination of the effect of cimetidine on the PK of dexpramipexole parameters including: AUC: Area under the plasma-concentration time curve over a specified time period; Cmax: Maximum observed plasma concentration and CLr: renal clearance [ Time Frame: pre-dose and at 15, 30, and 45 minutes, and 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, and 72 hours after dexpramipexole administration in each dosing period. ]

Secondary Outcome Measures :
  1. PK parameters of dexpramipexole including, but not limited to, half-life when given with or without cimetidine [ Time Frame: pre-dose and at 15, 30, and 45 minutes, and 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, and 72 hours after dexpramipexole administration in each dosing period. ]


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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:

  • Subjects who, in the opinion of the Investigator, are healthy as determined by medical history, physical examination, and 12 lead ECG
  • Adult males/females aged 18 to 55 years inclusive
  • Male and female subjects of childbearing potential must practice effective contraception during the study and up to 90 days after their last dose.

Exclusion Criteria:

  • History of malignant disease, including solid tumors and hematologic malignancies.
  • History of clinically significant endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, and renal, or other major diseases, as determined by the Investigator.
  • Treatment with prescription medication and/or over-the-counter products and herbal-containing and/or alternative health preparations and procedures.
  • Surgery within 90 days prior to check-in.

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): NCT01536249


Locations
United States, Kansas
Research Site
Overland Park, Kansas, United States
Sponsors and Collaborators
Knopp Biosciences

Responsible Party: Knopp Biosciences
ClinicalTrials.gov Identifier: NCT01536249     History of Changes
Other Study ID Numbers: 223HV104
First Posted: February 22, 2012    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
Cimetidine
Pramipexole
Anti-Ulcer Agents
Gastrointestinal Agents
Histamine H2 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Antioxidants
Protective Agents
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agonists
Dopamine Agents