Alzheimer's DiseasePhase 1NCT00825084
A Phase 1 Study To Evaluate The Pharmacokinetics, Safety, And Tolerability Of Dimebon [PF-01913539] In Japanese And Western Healthy Subjects
A Phase 1 study testing Dimebon in people with Alzheimer's Disease and Huntington's Disease, run by Pfizer at 1 site in United States.
Trial summary
This study is to characterize the pharmacokinetics of single and multiple oral doses of Dimebon in Japanese healthy subjects. This study is also to evaluate the safety and tolerability of single and multiple oral doses of Dimebon in Japanese healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease, Huntington's Disease
- What is being tested?
- Dimebon
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to May 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG, and clinical laboratory tests).
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight within the range of 50 to 100 kg.
- An informed consent document signed and dated by the subject or a legally-acceptable representative.
- Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- Japanese subjects must have four Japanese grandparents who were born in Japan.
Who cannot join
- Asian or Polynesian subjects in Western subject groups.
- Any condition possibly affecting drug absorption (e.g., gastrectomy, active peptic ulcer within last 3 months).
- History of regular alcohol consumption exceeding an average of 7 drinks/week for females and 14 drinks/week for men (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening.
- Subjects who, by history, smoke more than 5 cigarettes per day.
- Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication.
- 12-lead ECG demonstrating QTc >450 msec at screening. If QTc exceeds 450 msec, the ECG may be repeated two more times and the average of the three QTc values should be used to determine the subject's eligibility.
- Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of nonhormonal contraception as outlined in this protocol from at least 14 days prior to the first dose of study medication.
- Use of prescription or nonprescription drugs, vitamins and dietary supplements, within 7 days or 5 half-lives (whichever is longer) of the first dose of study medication. Herbal supplements and hormonal methods of contraception (including oral and transdermal contraceptives, injectable progesterone, progestin subdermal implants, progesterone-releasing IUDs, postcoital contraceptive methods) and hormone replacement therapy must be discontinued 28 days prior to the first dose of study medication. Depo-Provera® must be discontinued at least 6 months prior to the first dose of study medication. As an exception, acetaminophen/paracetamol may be used at doses of ≤ 2 grams/day. Limited use of non-prescription medications that are not believed to affect subject safety or the overall results of the study may be permitted on a case-by-case basis following approval by the sponsor.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pfizer Investigational Site
Glendale, California, 91206
About this study
Official title: A Phase 1, Randomized, Subject- And Investigator-Blind, Sponsor-Open, Placebo-Controlled, Parallel-Cohort, Single-Dose Escalation, And Multiple-Dose Titration Study To Evaluate The Pharmacokinetics, Safety, And Tolerability Of Dimebon [PF-01913539] In Japanese And Western Healthy Subjects
This study is to characterize the pharmacokinetics of single and multiple oral doses of Dimebon in Japanese healthy subjects. This study is also to evaluate the safety and tolerability of single and multiple oral doses of Dimebon in Japanese healthy subjects. The secondary objective of this study is to compare the pharmacokinetics, safety and tolerability of single and multiple oral doses of Dimebon in Japanese and Western healthy subjects.
- Conditions
- Alzheimer's Disease, Huntington's Disease
- Being tested
- Dimebon
- Keywords
- Dimebon, Japanese and Western population, pharmacokinetics
- Medical subject headings
- Alzheimer Disease, Huntington Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DimebonDrug
dose escalation of single oral doses of 5, 10 and 20 mg
DimebonDrug
dose escalation of single oral doses of 5, 10 and 20 mg
DimebonDrug
10 mg TID of Dimebon for 7 days followed by 20 mg TID of Dimebon for 7 days
DimebonDrug
10 mg TID of Dimebon for 7 days followed by 20 mg TID of Dimebon for 7 days
| Study group | Role | What they receive |
|---|---|---|
| single dose cohort-Japanese group | Experimental | Japanese healthy subjects Receives: Drug: Dimebon |
| single dose cohort-Western group | Experimental | Western healthy subjects Receives: Drug: Dimebon |
| multiple dose cohort-Japanese group | Experimental | Japanese healthy subjects Receives: Drug: Dimebon |
| multiple dose cohort-Western group | Experimental | Western healthy subjects Receives: Drug: Dimebon |
What is being measured
The primary outcome is the main question the study is designed to answer.
plasma drug concentrations
Measured: 72 hours post last dose
Secondary outcomes (1)
Safety will be including physical/neurological examination findings, clinical safety laboratory assessments, 12-lead ECGs, vital sign measurements and adverse event monitoring
Measured: 72 hours post last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2009 (estimated)
- Study startFeb 2009
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medivation, Inc.
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00825084
- Sponsor's protocol ID
- B1451014
- Status last verified
- Apr 2011
- First submitted
- 12 Jan 2009
- Last updated
- 26 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Subject- And Investigator-Blind, Sponsor-Open, Placebo-Controlled, Parallel-Cohort, Single-Dose Escalation, And Multiple-Dose Titration Study To Evaluate The Pharmacokinetics, Safety, And Tolerability Of Dimebon [PF-01913539] In Japanese And Western Healthy Subjects
- ClinicalTrials.gov ID
- NCT00825084
- Acronym / sponsor ID
- B1451014
- Conditions
- Alzheimer's Disease, Huntington's Disease
- Keywords
- Dimebon, Japanese and Western population, pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Collaborators
- Medivation, Inc.
- Study start
- Feb 2009
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 19 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to characterize the pharmacokinetics of single and multiple oral doses of Dimebon in Japanese healthy subjects. This study is also to evaluate the safety and tolerability of single and multiple oral doses of Dimebon in Japanese healthy subjects. The secondary objective of this study is to compare the pharmacokinetics, safety and tolerability of single and multiple oral doses of Dimebon in Japanese and Western healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| single dose cohort-Japanese group | Experimental | Drug: DimebonJapanese healthy subjects |
| single dose cohort-Western group | Experimental | Drug: DimebonWestern healthy subjects |
| multiple dose cohort-Japanese group | Experimental | Drug: DimebonJapanese healthy subjects |
| multiple dose cohort-Western group | Experimental | Drug: DimebonWestern healthy subjects |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG, and clinical laboratory tests).
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight within the range of 50 to 100 kg.
- An informed consent document signed and dated by the subject or a legally-acceptable representative.
- Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- Japanese subjects must have four Japanese grandparents who were born in Japan.
Key exclusion criteria (8 listed)
- Asian or Polynesian subjects in Western subject groups.
- Any condition possibly affecting drug absorption (e.g., gastrectomy, active peptic ulcer within last 3 months).
- History of regular alcohol consumption exceeding an average of 7 drinks/week for females and 14 drinks/week for men (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening.
- Subjects who, by history, smoke more than 5 cigarettes per day.
- Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dimebondose escalation of single oral doses of 5, 10 and 20 mg | Drug | single dose cohort-Japanese group |
| Dimebondose escalation of single oral doses of 5, 10 and 20 mg | Drug | single dose cohort-Western group |
| Dimebon10 mg TID of Dimebon for 7 days followed by 20 mg TID of Dimebon for 7 days | Drug | multiple dose cohort-Japanese group |
| Dimebon10 mg TID of Dimebon for 7 days followed by 20 mg TID of Dimebon for 7 days | Drug | multiple dose cohort-Western group |
Primary outcome
plasma drug concentrations
Time frame: 72 hours post last dose
1 secondary outcome
Safety will be including physical/neurological examination findings, clinical safety laboratory assessments, 12-lead ECGs, vital sign measurements and adverse event monitoring
Time frame: 72 hours post last dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2011.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dimebon in people with Alzheimer's Disease and Huntington's Disease, run by Pfizer at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
plasma drug concentrations (time frame: 72 hours post last dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2011.