A Phase 1 Study To Evaluate The Effect Of Dimebon On The Pharmacokinetics Of Dextromethorphan
This study has been completed.
Sponsor:
Pfizer
Collaborator:
Medivation, Inc.
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00788047
First received: November 7, 2008
Last updated: March 5, 2009
Last verified: March 2009
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Purpose
This drug-drug interaction study is being conducted to evaluate the potential effect of Dimebon on the pharmacokinetics on dextromethorphan, a probe substrate of the cytochrome P450 2D6 (CYP2D6) enzyme, after multiple dose administration to healthy adult subjects.
| Condition | Intervention | Phase |
|---|---|---|
|
Huntington Disease Alzheimer Disease |
Drug: Dextromethorphan Drug: Dimebon + Dextromethorphan |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | A Phase 1, Randomized, Open-Label, Two-Way Crossover Study To Evaluate The Steady-State Effect Of Dimebon [PF-01913539] On The Single-Dose Pharmacokinetics Of The CYP2D6 Substrate Dextromethorphan In Healthy Subjects |
Resource links provided by NLM:
Genetics Home Reference related topics:
Alzheimer disease
chorea-acanthocytosis
Huntington disease
McLeod neuroacanthocytosis syndrome
U.S. FDA Resources
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Dextromethorphan exposure in combination with Dimebon 20 mg TID relative to Dextromethorphan exposure alone [ Time Frame: Day 12 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Safety and Tolerability (Adverse Events, Vital Signs, Clinical Labs, Electrocardiograms) [ Time Frame: Day 15 ] [ Designated as safety issue: Yes ]
- Dextrorphan (the metabolite of dextromethorphan) exposure [ Time Frame: Day 12 ] [ Designated as safety issue: No ]
| Enrollment: | 14 |
| Study Start Date: | November 2008 |
| Study Completion Date: | January 2009 |
| Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Regimen A (Reference) |
Drug: Dextromethorphan
Dextromethorphan HCl 30 syrup single dose
|
| Experimental: Regimen B (Test) |
Drug: Dimebon + Dextromethorphan
Dimebon 20 mg tablets given three times daily for 14 days plus Dextromethorphan HCl 30 syrup single dose administered on Day 12
|
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Healthy adult subjects.
- Extensive or ultra-rapid metabolizers of CYP2D6 substrates, predicted by genotype.
Exclusion Criteria:
- Existence of significant medical conditions that would impact study results or pose unacceptable risks to study subjects.
- Pregnant or nursing females or females of childbearing potential who are unwilling or unable to use an acceptable method of contraception.
- Use of prescription or nonprescription drugs and dietary supplements within 7 days prior to the first dose of study medication.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00788047
Locations
| United States, Connecticut | |
| Pfizer Investigational Site | |
| New Haven, Connecticut, United States, 06511 | |
Sponsors and Collaborators
Pfizer
Medivation, Inc.
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
| ClinicalTrials.gov Identifier: | NCT00788047 History of Changes |
| Other Study ID Numbers: | B1451022 |
| Study First Received: | November 7, 2008 |
| Last Updated: | March 5, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Alzheimer Disease Huntington Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Basal Ganglia Diseases Chorea Dyskinesias Movement Disorders |
Heredodegenerative Disorders, Nervous System Genetic Diseases, Inborn Cognition Disorders Dextromethorphan Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Antitussive Agents Central Nervous System Agents Therapeutic Uses Respiratory System Agents |
ClinicalTrials.gov processed this record on May 16, 2013