Dexpramipexole and Cimetidine Drug Drug Interaction (DDI)
Information source: Knopp Biosciences
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Amyotrophic Lateral Sclerosis
Intervention: Dexpramipexole (Drug); Cimetidine plus Dexpramipexole (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Knopp Biosciences
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.
Clinical Details
Official title: An Open-Label Study to Assess the Effect of Cimetidine on the Pharmacokinetics of Dexpramipexole (BIIB050) in Healthy Volunteers
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: 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
Secondary outcome: PK parameters of dexpramipexole including, but not limited to, half-life when given with or without cimetidine
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
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.
Locations and Contacts
Research Site, Overland Park, Kansas, United States
Additional Information
Starting date: March 2012
Last updated: November 24, 2014
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