A Study In Healthy Volunteers To Estimate The Pharmacokinetics Of Four Modified-Release Formulations Of Dimebon (Latrepirdine)
This study has been completed.
Sponsor:
Pfizer
Collaborator:
Medivation, Inc.
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00988624
First received: October 1, 2009
Last updated: January 11, 2010
Last verified: January 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Alzheimer's Disease Huntington Disease |
Drug: Dimebon IR Tablet Drug: Dimebon MR1 Drug: Dimebon MR2 Drug: Dimebon MR3 Drug: Dimebon MR4 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-availability Study Intervention Model: Crossover Assignment Masking: Open Label |
| Official 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) |
Resource links provided by NLM:
Genetics Home Reference related topics:
Alzheimer disease
chorea-acanthocytosis
Huntington disease
McLeod neuroacanthocytosis syndrome
U.S. FDA Resources
Further study details as provided by Pfizer:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
| Enrollment: | 20 |
| Study Start Date: | October 2009 |
| Study Completion Date: | December 2009 |
| Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Period 1 |
Drug: Dimebon IR Tablet
Pharmacokinetics of a single oral dose of 10 mg dimebon immediate release tablet will be assessed on Day 1 - 3.
|
| Experimental: Period 2 |
Drug: Dimebon MR1
Pharmacokinetics of a single oral dose of 10 mg dimebon modified release formulation, MR1, will be assessed on Day 1 - 3.
|
| Experimental: Period 3 |
Drug: Dimebon MR2
Pharmacokinetics of a single oral dose of 10 mg dimebon modified release formulation, MR2, will be assessed on Day 1 - 3.
|
| Experimental: Period 4 |
Drug: Dimebon MR3
Pharmacokinetics of a single oral dose of 10 mg dimebon modified release formulation, MR3, will be assessed on Day 1 - 3.
|
| Experimental: Period 5 |
Drug: Dimebon MR4
Pharmacokinetics of a single oral dose of 10 mg dimebon modified release formulation, MR4, will be assessed on Day 1 - 3.
|
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00988624
Locations
| United States, Connecticut | |
| Pfizer Investigational Site | |
| New Haven, Connecticut, United States, 06511 | |
Sponsors and Collaborators
Pfizer
Medivation, Inc.
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
| ClinicalTrials.gov Identifier: | NCT00988624 History of Changes |
| Other Study ID Numbers: | B1451023 |
| Study First Received: | October 1, 2009 |
| Last Updated: | January 11, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
bioavailability pharmacokinetics Alzheimer's Disease Huntington Disease |
Additional relevant MeSH terms:
|
Alzheimer Disease Huntington Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders |
Mental Disorders Basal Ganglia Diseases Chorea Dyskinesias Movement Disorders Heredodegenerative Disorders, Nervous System Genetic Diseases, Inborn Cognition Disorders |
ClinicalTrials.gov processed this record on May 23, 2013