A Study In Healthy Volunteers To Estimate The Pharmacokinetics Of Four Modified-Release Formulations Of Dimebon (Latrepirdine)

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00988624
• Date of registration: 01/10/2009
• Prospective Registration: Yes
• Primary sponsor: Pfizer
• Public title: A Study In Healthy Volunteers To Estimate The Pharmacokinetics Of Four Modified-Release Formulations Of Dimebon (Latrepirdine)
• Scientific title: A Phase 1, Randomized, Open-Label, Single Dose Cross-Over Study In Healthy Volunteers To Estimate The Pharmacokinetics Of Four Modified-Release Formulations Of Dimebon (Latrepirdine)
• Date of first enrolment: October 2009
• Target sample size: 20
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00988624
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion criteria

Inclusion Criteria:

- Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive.

Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).

Exclusion Criteria:

- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
allergic disease (including drug allergies, but excluding untreated, asymptomatic,
seasonal allergies at time of dosing).

- Subjects with any history of a previous seizure (including childhood febrile
seizures) or convulsion or significant head trauma.

- Subjects with hypersensitivity reactions to dimebon or other antihistamines.

- Any condition possibly affecting drug absorption (eg, gastrectomy).

- Smokers who use greater than 5 cigarettes per day.

- Use of proton pump inhibitors, antacids, and H2-blockers are prohibited for the
duration of the study.

- Pregnant or nursing females; females of childbearing potential who are unwilling or
unable to use an acceptable method of non-hormonal contraception.



Age minimum: 18 Years
Age maximum: 55 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Alzheimer's Disease

Huntington Disease

Intervention(s)

Drug: Dimebon MR2

Drug: Dimebon MR1

Drug: Dimebon IR Tablet

Drug: Dimebon MR3

Drug: Dimebon MR4

Primary Outcome(s)

PK endpoints for dimebon and M7 (where appropriate) for each formulation: AUC0-24, AUC0-24(dn), AUCinf (as data permit) AUCinf(dn), AUClast, AUClast(dn), Tlag, Cmax, Tmax, and t1/2 (as data permit). [Time Frame: Day 1-3 of Period 1, 2, 3, 4, or 5]

Secondary Outcome(s)

Safety and tolerability for each formulation (AEs, ECG, vital signs, safety labs) [Time Frame: Day 1-3 of Period 1, 2, 3, 4, or 5]

Secondary ID(s)

B1451023

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Medivation, Inc.