HealthyPhase 1MADNCT01159496
Multiple Ascending Dose Study To Assess Safety, Tolerability And Pharmacokinetics Of PF-05212377 (SAM-760)
A Phase 1 study testing PF-05212377 (SAM-760) in people with Healthy, run by Pfizer at 1 site in France.
Trial summary
This is a multiple ascending dose study to assess the safety, tolerability and pharmacokinetics of PF-05212377 (SAM-760) administered orally once a day for 14 days to healthy young adults and healthy elderly subjects. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- PF-05212377 (SAM-760)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2010to Dec 2010
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Inclusion Criteria for young healthy population: Healthy male and/or female subjects of non-child bearing potential (WONCBP) between the ages of 18 and 55 years, inclusive. (Healthy is defined as no clinically relevant abnormalities identified at screening by a detailed medical history, full physical examination, including blood pressure and heart rate measurement, 12-lead ECG, neurological examination and clinical laboratory tests.)
- Inclusion Criteria for elderly population: Healthy male and/or female subjects of non-child bearing potential between the ages of 65 and 85 years, inclusive. Subjects must be in reasonably good health as determined by the investigator based on a detailed medical history, full physical examination (including blood pressure and pulse rate measurement), 12-lead ECG and clinical laboratory tests. Subjects with mild, chronic, stable disease (eg, controlled hypertension, non-insulin dependent diabetes, osteoarthritis) may be enrolled if deemed medically prudent by the investigator.
Who cannot join
- Presence or history of any disorder that may prevent the successful completion of the study.
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
- A score of greater than or equal to 20 on the Beck Depression Inventory and/or a response of 1, 2, or 3 to the question related to suicide.
- History of seizure disorder and/or severe head trauma (other than a single childhood febrile seizure).
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, dermatologic, muscular or allergic disease or disorder (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- Any surgical or medical condition that may interfere with the absorption, distribution, metabolism, or excretion of the study treatment.
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- Acute disease state (eg, nausea, vomiting, fever, or diarrhea) within 7 days before study Day 1.
- History of drug abuse within 1 year before study Day 1 or a positive urine drug screen.
- Admitted alcohol abuse or history of alcohol use that may interfere with the subject's ability to comply with the protocol requirements.
- Consumption of more than 14 drinks/week for females or 21 drinks/week for males (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 smoke more than 10 cigarettes per day.
- Pregnant or nursing females; females of childbearing potential.
- Males who are unwilling to abstain from sexual intercourse or use a condom with all child-bearing potential women for the duration of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Investigator And Subject-Blind, Sponsor Open, Placebo Controlled Phase 1 Study To Characterize The Safety, Tolerability, And Pharmacokinetics Of Ascending Multiple Doses Of PF-05212377 (SAM-760) Administered Orally To Healthy Young And Elderly Subjects
This is a multiple ascending dose study to assess the safety, tolerability and pharmacokinetics of PF-05212377 (SAM-760) administered orally once a day for 14 days to healthy young adults and healthy elderly subjects. The study will be conducted under double-blind conditions (neither the investigator nor the subject will know if he/she has received PF-05212377 or a placebo). The Sponsor will know if the subject has received active treatment or a placebo.
- Conditions
- Healthy
- Being tested
- PF-05212377 (SAM-760), Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-05212377 (SAM-760)Drug
Also called SAM-760
Oral capsule, once daily for 14 days 1.5 mg, 5 mg, 15 mg, 30 mg and 50 mg
PlaceboDrug
Oral capsule, once daily for 14 days
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Not described Receives: Drug: PF-05212377 (SAM-760) |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events (spontaneous and solicited).
Measured: 0-24days
Change from baseline in vital signs.
Measured: 0-24 days
Change from baseline in triplicate ECGs.
Measured: 0-24 days
Clinical safety laboratory endpoints, including a complete blood count, reticulocytes and a full chemistry panel, including electrolytes, hepatic transaminases, and urinalysis, with microscopic analysis if dipstick analysis is positive.
Measured: 0-24 days
Physical examinations and neurological examinations
Measured: 0-24 days
Secondary outcomes (2)
Pharmacokinetics in young adults (Plasma concentration of PF-05212377 over time (eg, AUC, Cmax, Tmax, t1/2).
Measured: 0-21 days
Pharmacokinetics in elderly subjects (Plasma concentration of PF-05212377 over time (eg, AUC, Cmax, Tmax, t1/2).
Measured: 0-21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01159496
- Sponsor's protocol ID
- B2081003
- Acronym
- MAD
- Status last verified
- Mar 2011
- First submitted
- 7 Jul 2010
- Last updated
- 10 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Investigator And Subject-Blind, Sponsor Open, Placebo Controlled Phase 1 Study To Characterize The Safety, Tolerability, And Pharmacokinetics Of Ascending Multiple Doses Of PF-05212377 (SAM-760) Administered Orally To Healthy Young And Elderly Subjects
- ClinicalTrials.gov ID
- NCT01159496
- Acronym / sponsor ID
- MAD / B2081003
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 9 Jul 2010 (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 is a multiple ascending dose study to assess the safety, tolerability and pharmacokinetics of PF-05212377 (SAM-760) administered orally once a day for 14 days to healthy young adults and healthy elderly subjects. The study will be conducted under double-blind conditions (neither the investigator nor the subject will know if he/she has received PF-05212377 or a placebo). The Sponsor will know if the subject has received active treatment or a placebo.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Drug: PF-05212377 (SAM-760) |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Inclusion Criteria for young healthy population: Healthy male and/or female subjects of non-child bearing potential (WONCBP) between the ages of 18 and 55 years, inclusive. (Healthy is defined as no clinically relevant abnormalities identified at screening by a detailed medical history, full physical examination, including blood pressure and heart rate measurement, 12-lead ECG, neurological examination and clinical laboratory tests.)
- Inclusion Criteria for elderly population: Healthy male and/or female subjects of non-child bearing potential between the ages of 65 and 85 years, inclusive. Subjects must be in reasonably good health as determined by the investigator based on a detailed medical history, full physical examination (including blood pressure and pulse rate measurement), 12-lead ECG and clinical laboratory tests. Subjects with mild, chronic, stable disease (eg, controlled hypertension, non-insulin dependent diabetes, osteoarthritis) may be enrolled if deemed medically prudent by the investigator.
Key exclusion criteria (13 listed)
- Presence or history of any disorder that may prevent the successful completion of the study.
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
- A score of greater than or equal to 20 on the Beck Depression Inventory and/or a response of 1, 2, or 3 to the question related to suicide.
- History of seizure disorder and/or severe head trauma (other than a single childhood febrile seizure).
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, dermatologic, muscular or allergic disease or disorder (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
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 |
|---|---|---|
| PF-05212377 (SAM-760)Also: SAM-760Oral capsule, once daily for 14 days 1.5 mg, 5 mg, 15 mg, 30 mg and 50 mg | Drug | Active |
| PlaceboOral capsule, once daily for 14 days | Drug | Placebo |
Primary outcome
Adverse events (spontaneous and solicited).
Time frame: 0-24days
Change from baseline in vital signs.
Time frame: 0-24 days
Change from baseline in triplicate ECGs.
Time frame: 0-24 days
Clinical safety laboratory endpoints, including a complete blood count, reticulocytes and a full chemistry panel, including electrolytes, hepatic transaminases, and urinalysis, with microscopic analysis if dipstick analysis is positive.
Time frame: 0-24 days
Physical examinations and neurological examinations
Time frame: 0-24 days
2 secondary outcomes
Pharmacokinetics in young adults (Plasma concentration of PF-05212377 over time (eg, AUC, Cmax, Tmax, t1/2).
Time frame: 0-21 days
Pharmacokinetics in elderly subjects (Plasma concentration of PF-05212377 over time (eg, AUC, Cmax, Tmax, t1/2).
Time frame: 0-21 days
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 10 Mar 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 PF-05212377 (SAM-760) in people with Healthy, run by Pfizer at 1 site in France.
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 2 inclusion and 13 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 10 Mar 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 France. 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. Some participants in this study may receive a placebo. 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?
Adverse events (spontaneous and solicited). (time frame: 0-24days). The study lists 5 primary outcomes in all. 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 10 Mar 2011.