A Phase 1 Study To Evaluate The Effect Of Dimebon On The Pharmacokinetics Of Dextromethorphan

Alzheimer Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00788047
• Other study ID #: B1451022
• Status: Completed
• Phase: Phase 1
• First received: November 7, 2008
• Last updated: March 5, 2009
• Start date: November 2008
• Est. completion date: January 2009

Study information

• Verified date: March 2009
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Huntington Disease

Intervention

Drug:
• Dextromethorphan
Dextromethorphan HCl 30 syrup single dose
• Dimebon + Dextromethorphan
Dimebon 20 mg tablets given three times daily for 14 days plus Dextromethorphan HCl 30 syrup single dose administered on Day 12

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Pfizer	Medivation, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dextromethorphan exposure in combination with Dimebon 20 mg TID relative to Dextromethorphan exposure alone		Day 12	No
Secondary	Safety and Tolerability (Adverse Events, Vital Signs, Clinical Labs, Electrocardiograms)		Day 15	Yes
Secondary	Dextrorphan (the metabolite of dextromethorphan) exposure		Day 12	No

External Links

•   To obtain contact information for a study center near you, click here.