Dexpramipexole and Cimetidine Drug Drug Interaction (DDI)

Phase 1

Completed

• Conditions: Amyotrophic Lateral Sclerosis
• Interventions: Drug: Cimetidine plus Dexpramipexole; Drug: Dexpramipexole

• Registration Number: NCT01536249
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2012-02-16
• Study First Submitted QC: 2012-02-21
• Study First Posted: 2012-02-22
• Study Start: 2012-03
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-24
• Last Update Posted: 2014-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Dexpramipexole single dose & 12 Doses Cimetidine	Cimetidine plus Dexpramipexole	300 mg Dexpramipexole Oral Dose (to be taken in conjunction with multiple doses of Cimetidine at 400 mg per dose)
Dexpramipexole single Dose	Dexpramipexole	300 mg Dexpramipexole Oral Dose

Primary Outcome Measures

Name	Time	Method
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	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

Name	Time	Method
PK parameters of dexpramipexole including, but not limited to, half-life when given with or without cimetidine	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.

Trial Locations

Locations (1)

Research Site; 🇺🇸 Overland Park, Kansas, United States