Alzheimer's Disease, Huntington Disease
Conditions
Keywords
bioavailability pharmacokinetics Alzheimer's Disease Huntington Disease
Brief summary
This study will evaluate four different modified release formulation to estimate the amount of dimebon available to the body relative to the current dimebon formulation that is given three times a day. The results of this study will help inform and guide further formulation development efforts with the ultimate goal of reducing dose frequency to once-a-day or twice-a-day.
Interventions
DRUGDimebon IR Tablet
Pharmacokinetics of a single oral dose of 10 mg dimebon immediate release tablet will be assessed on Day 1 - 3.
DRUGDimebon MR1
Pharmacokinetics of a single oral dose of 10 mg dimebon modified release formulation, MR1, will be assessed on Day 1 - 3.
DRUGDimebon MR2
Pharmacokinetics of a single oral dose of 10 mg dimebon modified release formulation, MR2, will be assessed on Day 1 - 3.
DRUGDimebon MR3
Pharmacokinetics of a single oral dose of 10 mg dimebon modified release formulation, MR3, will be assessed on Day 1 - 3.
DRUGDimebon MR4
Pharmacokinetics of a single oral dose of 10 mg dimebon modified release formulation, MR4, will be assessed on Day 1 - 3.
Sponsors
Medivation, Inc.
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). | Day 1-3 of Period 1, 2, 3, 4, or 5 |
Secondary
| Measure | Time frame |
|---|---|
| Safety and tolerability for each formulation (AEs, ECG, vital signs, safety labs) | Day 1-3 of Period 1, 2, 3, 4, or 5 |
Countries
United States
Outcome results
None listed