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Dexpramipexole and Cimetidine Drug Drug Interaction (DDI)

Primary Purpose

Amyotrophic Lateral Sclerosis

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Dexpramipexole

Cimetidine plus Dexpramipexole

About this trial

This is an interventional treatment trial for Amyotrophic Lateral Sclerosis

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Research Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Dexpramipexole single dose & 12 Doses Cimetidine

Dexpramipexole single Dose

Arm Description

300 mg Dexpramipexole Oral Dose (to be taken in conjunction with multiple doses of Cimetidine at 400 mg per dose)

300 mg Dexpramipexole Oral Dose

Outcomes

Primary Outcome Measures

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 Measures

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

Full Information

NCT ID

NCT01536249

First Posted

February 16, 2012

Last Updated

November 24, 2014

Sponsor

Knopp Biosciences

1. Study Identification

Unique Protocol Identification Number

NCT01536249

Brief Title

Dexpramipexole and Cimetidine Drug Drug Interaction (DDI)

Official Title

An Open-Label Study to Assess the Effect of Cimetidine on the Pharmacokinetics of Dexpramipexole (BIIB050) in Healthy Volunteers

Study Type

Interventional

2. Study Status

Record Verification Date

November 2014

Overall Recruitment Status

Completed

Study Start Date

March 2012 (undefined)

Primary Completion Date

April 2012 (Actual)

Study Completion Date

April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Knopp Biosciences

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Amyotrophic Lateral Sclerosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dexpramipexole single dose & 12 Doses Cimetidine

Arm Type

Experimental

Arm Description

300 mg Dexpramipexole Oral Dose (to be taken in conjunction with multiple doses of Cimetidine at 400 mg per dose)

Arm Title

Dexpramipexole single Dose

Arm Type

Experimental

Arm Description

300 mg Dexpramipexole Oral Dose

Intervention Type

Drug

Intervention Name(s)

Dexpramipexole

Intervention Description

Single Oral Dose

Intervention Type

Drug

Intervention Name(s)

Cimetidine plus Dexpramipexole

Intervention Description

Multiple Oral Doses

Primary Outcome Measure Information:

Title

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 Outcome Measure Information:

Title

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility 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.

Facility Information:

Facility Name

Research Site

City

Overland Park

State/Province

Kansas

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Dexpramipexole and Cimetidine Drug Drug Interaction (DDI)

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