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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Alzheimer Disease; Huntington Disease

Treatments: Drug: Dimebon + Dextromethorphan; Drug: Dextromethorphan

Study type: Interventional

Funder types: Industry

Identifiers

NCT00788047

B1451022

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

14 participants in 2 patient groups

Regimen A (Reference)

Other group

Treatment:

Drug: Dextromethorphan

Regimen B (Test)

Experimental group

Treatment:

Drug: Dimebon + Dextromethorphan