Study Purpose:
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.Study Status:
Not recruiting
Disease:
Amyotrophic Lateral Sclerosis
Study Type:
Interventional
Type of Intervention:
Drug
Intervention Name:
Dexpramipexole, Cimetidine plus Dexpramipexole
Placebo:
Phase:
Phase 1
Study Chair(s)/Principal Investigator(s):
N/A
Clinicaltrials.gov ID:
Neals Affiliated?
No
Coordinating Center Contact Information
Research Site
Overland Park, Kansas, 66212 United States
Full Study Summary:
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.
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 Sponsor:
Knopp Biosciences
Estimated Enrollment:
14
Estimated Study Start Date:
02 / 29 / 2012
Estimated Study Completion Date:
04 / 01 / 2012
Posting Last Modified Date:
11 / 25 / 2014
Date Study Added to neals.org:
02 / 22 / 2012
Minimum Age:
18 Years
Maximum Age:
55 Years
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.
Research Site
Overland Park, Kansas
United States