Dexpramipexole and Cimetidine Drug Drug Interaction (DDI)

Knopp Biosciences14 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Amyotrophic Lateral Sclerosis

Interventions

DexpramipexoleDRUG

Single Oral Dose

Cimetidine plus DexpramipexoleDRUG

Multiple Oral Doses

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 (1)

Research Site

Overland Park, Kansas, United States

Outcomes

Primary Outcomes

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 Outcomes

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.

Data from ClinicalTrials.gov

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