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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

Page last updated: August 23, 2015

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