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CompletedPhase 1

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

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

Lead sponsor

Pfizer

Asset

Dimebon

Listed sites

1

Recruiting sites

-

Enrollment

14

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Age 18-55

Primary endpoint

•Dextromethorphan exposure in combination

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDB1451022
NCT IDNCT00788047

Timeline

Milestones

Study start2008-11 (month precision)
Study first posted2008-11-10estimated
Primary completion2009-01actual (month precision)
Study completion2009-01actual (month precision)
Last update posted2009-03-09estimated

Assets

Drug assets

Dimebon

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age18 Years
Maximum age55 Years
SexAll
Healthy volunteersAccepted

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.

Endpoints (3)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)
2
Safety / tolerability / PK
1

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

Safety and Tolerability (Adverse Events, Vital Signs, Clinical Labs, Electrocardiograms)

Time frame:Day 15

event count, event

Other (unclassified)

2 endpoints
Primary/protocol endpoint/low confidence

Dextromethorphan exposure in combination with Dimebon 20 mg TID relative to Dextromethorphan exposure alone

Time frame:Day 12

descriptive

Secondary/protocol endpoint/low confidence

Dextrorphan (the metabolite of dextromethorphan) exposure

Time frame:Day 12

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.