Dexpramipexole and Cimetidine Drug Drug Interaction (DDI)

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01536249
• Other study ID #: 223HV104
• Status: Completed
• Phase: Phase 1
• First received: February 16, 2012
• Last updated: November 24, 2014
• Start date: March 2012
• Est. completion date: April 2012

Study information

• Verified date: November 2014
• Source: Knopp Biosciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis

Intervention

Drug:
• Dexpramipexole
Single Oral Dose
• Cimetidine plus Dexpramipexole
Multiple Oral Doses

Locations

Country	Name	City	State
United States	Research Site	Overland Park	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Knopp Biosciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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.	No