HealthyPhase 1NCT00948662
Study Evaluating The Safety And Tolerability Of Administration Of Single Oral Doses Of SAM-760 To Healthy Subjects
A Phase 1 study testing SAM-760 and ketoconazole in people with Healthy, run by Pfizer at 1 site in France.
Trial summary
This study will assess the safety and tolerability of ascending single oral doses of SAM-760 in healthy young adult and healthy elderly subjects. The secondary objectives are to provide the concentrations of SAM-760 in the blood and to evaluate the effect of a high-fat meal on the concentrations in the blood of… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- SAM-760 and ketoconazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2009to 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men or women of non-childbearing potential aged 18 to 50 years inclusive (healthy young subjects) and > 65 years (healthy elderly subjects) at screening.
- Body mass index (BMI) in the range of 18 to 32 kg/m2 and body weight >= 50 kg.
Who cannot join
- Presence or history of any disorder that may prevent the successful completion of the study.
- Any surgical or medical condition that may interfere with the absorption, distribution, metabolism, or excretion of the investigational drug or placebo.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ascending Single Dose Study Of The Safety, Tolerability And Pharmacokinetics Of SAM-760 Administered Orally To Healthy Young And Healthy Elderly Subjects
This study will assess the safety and tolerability of ascending single oral doses of SAM-760 in healthy young adult and healthy elderly subjects. The secondary objectives are to provide the concentrations of SAM-760 in the blood and to evaluate the effect of a high-fat meal on the concentrations in the blood of SAM-760 administered to healthy young adult subjects, and to evaluate the effects of concomitant administration of ketoconazole on the safety and the concentrations of SAM-760 in the blood of a single dose of SAM-760 in healthy young adult subjects.
- Conditions
- Healthy
- Being tested
- SAM-760, Placebo of SAM-760, ketoconazole
- Keywords
- Safety, tolerability, ascending single doses, healthy subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAM-760Drug
SAM-760 capsule, 0.25, 0.75, 2.25, 5, 10, 15, 20, 25, 35 and 45mg, single dose, 1 day
Placebo of SAM-760Drug
Also called Placebo
SAM-760 matching placebo capsule, single dose, 1 day,
ketoconazoleDrug
Also called ketoconazole interaction arm
Ketoconazole oral tablets, 200 mg bid, 14 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | active arm/healthy young Receives: Drug: SAM-760 |
| 2 | Placebo comparator | placebo arm Receives: Drug: Placebo of SAM-760 |
| 3 | Other | ketoconazole interaction evaluation Receives: Drug: ketoconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events as a measure of safety and tolerability.
Measured: 5 days
Secondary outcomes (4)
Maximum concentration (Cmax) for PF-05212377 over time.
Measured: 5 days
Measurement of Area Under the curve (AUC) for PF-05212377.
Measured: 5 days
Time of maximum (Tmax) concentration of PF-05212377 in plasma.
Measured: 5 days
Elimination half life (t1/2) of PF-05212377.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2009 (estimated)
- Study startSep 2009
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00948662
- Sponsor's protocol ID
- 3276A1-1000
- Other IDs
- B2081001
- Status last verified
- Feb 2013
- First submitted
- 28 Jul 2009
- Last updated
- 25 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ascending Single Dose Study Of The Safety, Tolerability And Pharmacokinetics Of SAM-760 Administered Orally To Healthy Young And Healthy Elderly Subjects
- ClinicalTrials.gov ID
- NCT00948662
- Acronym / sponsor ID
- 3276A1-1000
- Conditions
- Healthy
- Keywords
- Safety, tolerability, ascending single doses, healthy subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 29 Jul 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 will assess the safety and tolerability of ascending single oral doses of SAM-760 in healthy young adult and healthy elderly subjects. The secondary objectives are to provide the concentrations of SAM-760 in the blood and to evaluate the effect of a high-fat meal on the concentrations in the blood of SAM-760 administered to healthy young adult subjects, and to evaluate the effects of concomitant administration of ketoconazole on the safety and the concentrations of SAM-760 in the blood of a single dose of SAM-760 in healthy young adult subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: SAM-760active arm/healthy young |
| 2 | Placebo comparator | Drug: Placebo of SAM-760placebo arm |
| 3 | Other | Drug: ketoconazoleketoconazole interaction evaluation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Men or women of non-childbearing potential aged 18 to 50 years inclusive (healthy young subjects) and > 65 years (healthy elderly subjects) at screening.
- Body mass index (BMI) in the range of 18 to 32 kg/m2 and body weight >= 50 kg.
Key exclusion criteria (2 listed)
- Presence or history of any disorder that may prevent the successful completion of the study.
- Any surgical or medical condition that may interfere with the absorption, distribution, metabolism, or excretion of the investigational drug or placebo.
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 |
|---|---|---|
| SAM-760SAM-760 capsule, 0.25, 0.75, 2.25, 5, 10, 15, 20, 25, 35 and 45mg, single dose, 1 day | Drug | 1 |
| Placebo of SAM-760Also: PlaceboSAM-760 matching placebo capsule, single dose, 1 day, | Drug | 2 |
| ketoconazoleAlso: ketoconazole interaction armKetoconazole oral tablets, 200 mg bid, 14 days | Drug | 3 |
Primary outcome
Number of participants with adverse events as a measure of safety and tolerability.
Time frame: 5 days
4 secondary outcomes
Maximum concentration (Cmax) for PF-05212377 over time.
Time frame: 5 days
Measurement of Area Under the curve (AUC) for PF-05212377.
Time frame: 5 days
Time of maximum (Tmax) concentration of PF-05212377 in plasma.
Time frame: 5 days
Elimination half life (t1/2) of PF-05212377.
Time frame: 5 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 25 Feb 2013.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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 SAM-760 and ketoconazole 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 2 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 25 Feb 2013. 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?
Number of participants with adverse events as a measure of safety and tolerability. (time frame: 5 days). 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 25 Feb 2013.