Dexpramipexole and Cimetidine Drug Drug Interaction (DDI)
This study has been completed.
Sponsor:
Biogen Idec
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01536249
First received: February 16, 2012
Last updated: July 19, 2012
Last verified: July 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Amyotrophic Lateral Sclerosis |
Drug: Dexpramipexole Drug: Cimetidine plus Dexpramipexole |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-Label Study to Assess the Effect of Cimetidine on the Pharmacokinetics of Dexpramipexole (BIIB050) in Healthy Volunteers |
Resource links provided by NLM:
Genetics Home Reference related topics:
amyotrophic lateral sclerosis
MedlinePlus related topics:
Amyotrophic Lateral Sclerosis
Drug Information available for:
Cimetidine
Cimetidine hydrochloride
Pramipexole dihydrochloride
Pramipexole
U.S. FDA Resources
Further study details as provided by Biogen Idec:
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 [ 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. ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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. ] [ Designated as safety issue: No ]
| Enrollment: | 14 |
| Study Start Date: | March 2012 |
| Study Completion Date: | April 2012 |
| Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Dexpramipexole single dose & 12 Doses Cimetidine
300 mg Dexpramipexole Oral Dose (to be taken in conjunction with multiple doses of Cimetidine at 400 mg per dose)
|
Drug: Cimetidine plus Dexpramipexole
Multiple Oral Doses
|
|
Experimental: Dexpramipexole single Dose
300 mg Dexpramipexole Oral Dose
|
Drug: Dexpramipexole
Single Oral Dose
|
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| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Biogen Idec Medical Director, Biogen Idec, Inc. |
| ClinicalTrials.gov Identifier: | NCT01536249 History of Changes |
| Other Study ID Numbers: | 223HV104 |
| Study First Received: | February 16, 2012 |
| Last Updated: | July 19, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Amyotrophic Lateral Sclerosis Sclerosis Motor Neuron Disease Spinal Cord Diseases Central Nervous System Diseases Nervous System Diseases Neurodegenerative Diseases TDP-43 Proteinopathies Neuromuscular Diseases Proteostasis Deficiencies Metabolic Diseases Pathologic Processes Cimetidine Pramipexol Enzyme Inhibitors |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Histamine H2 Antagonists Histamine Antagonists Histamine Agents Neurotransmitter Agents Physiological Effects of Drugs Anti-Ulcer Agents Gastrointestinal Agents Therapeutic Uses Antioxidants Protective Agents Antiparkinson Agents Anti-Dyskinesia Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 19, 2013