Clinical trial NCT01536249: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Amyotrophic Lateral Sclerosis
Lead sponsor: Knopp Biosciences
Sponsor class: INDUSTRY
First posted: 2012-02-22
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: 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
timeFrame: 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:
measure: PK parameters of dexpramipexole including, but not limited to, half-life when given with or without cimetidine
timeFrame: 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.
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Research Site
state: Kansas
Study officials:
References: