Dexpramipexole and Cimetidine Drug Drug Interaction (DDI)

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01536249

Enrollment

Registered

2012-02-22

Start date

2012-03-31

Completion date

2012-04-30

Last updated

2014-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amyotrophic Lateral Sclerosis

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.

Interventions

DRUGDexpramipexole

Single Oral Dose

DRUGCimetidine plus Dexpramipexole

Multiple Oral Doses

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026