HealthyPhase 1NCT01089738
A Study To Look At Safety And Blood Concentrations After Multiple Doses Of PF-03382792 In Healthy Elderly Individuals
A Phase 1 study testing PF-03382792 0.5mg, PF-03382792 1.5 mg and PF-03382792 5 mg in people with Healthy, run by Pfizer.
Trial summary
This study is designed to look at the safety and blood concentrations of PF-03382792 in healthy elderly subjects after taking multiple doses for 14 days. Read more about this study
- Who is it for?
- Ages 65 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- PF-03382792 0.5mg, PF-03382792 1.5 mg and PF-03382792 5 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2010to 25 Apr 2011
- 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 65 to 80 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Healthy volunteer aged 65-80 years old
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2
- Total body weight >50 kg (110 lbs).
Who cannot join
- 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 symptoms or signs of adrenal insufficiency.
- Subjects with clinically significant ocular lens abnormalities as detected by the investigator based on the findings of a slit lamp examination performed by an ophthalmologist.
About this study
Official title: An Investigator And Subject-blind Phase 1 Study To Characterize The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Multiple Doses Of Pf-03382792 In Healthy Elderly Subjects
This study is designed to look at the safety and blood concentrations of PF-03382792 in healthy elderly subjects after taking multiple doses for 14 days.
Read the detailed description
To examine safety, toleratibilty and pharmacokinetics of PF-03382792 in healthy elderly subjects.
- Conditions
- Healthy
- Being tested
- PF-03382792 0.5mg, PF-03382792 1.5 mg, PF-03382792 5 mg, PF-03382792 15 mg
- Keywords
- mulitple dose, pharmacokinetics, safety, healthy elderly volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-03382792 0.5mgDrug
0.5 mg PF-03382792, qd, for 14 days or placebo
PF-03382792 1.5 mgDrug
1.5 mg PF-03382792, qd, for 14 days or placebo
PF-03382792 5 mgDrug
5 mg PF-03382792, qd, for 14 days or placebo
PF-03382792 15 mgDrug
15 mg PF-03382792, qd, for 14 days or placebo
| Study group | Role | What they receive |
|---|---|---|
| Dosing | Experimental | Ascending Doses Receives: Drug: PF-03382792 0.5mg; Drug: PF-03382792 1.5 mg; Drug: PF-03382792 5 mg; Drug: PF-03382792 15 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Endpoints include: AEs, vital signs, triplicate ECGs,
Measured: Day 0 to Day 28
Safety Endpoints include: Cosyntropin Stimulation Test, Clinical Examinations, Slit Lamp Examination, Aldosterone Concentrations
Measured: Day 0 to Day 28
Safety Endpoints include: safety laboratory endpoints (including a complete blood count and a full chemistry panel, including electrolytes, hepatic transaminases, and urinalysis, with microscopic analysis if dipstick analysis is positive),
Measured: Day 0 to Day 28
Pharmacokinetic endpoints include: Plasma concentrations of PF 03382792 and its N dealkylated metabolite, PF 03227077, will be measured and used to determine Cmax, Tmax, AUC on Day 1 and Css,max, Tss,max, AUC, Css,min, Css,avg on Days 7 and 14.
Measured: Day 0 to Day 28
Additional pharmacokinetic endpoints: the accumulation ratio (Rac) will be determined from Day 14 and Day 1 AUC. If data permit, t1/2 and urinary excretion parameters (CLR for the parent and Ae and Ae%) will be calculated.
Measured: Day 0 to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2010 (estimated)
- Study start1 Nov 2010
- Primary completion25 Apr 2011 (estimated)
- Study completion25 Apr 2011 (estimated)
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
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 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
- NCT01089738
- Sponsor's protocol ID
- B1651003
- Status last verified
- Nov 2018
- First submitted
- 17 Mar 2010
- Last updated
- 6 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical\_trials/trial\_data\_and\_results/data\_requests
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigator And Subject-blind Phase 1 Study To Characterize The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Multiple Doses Of Pf-03382792 In Healthy Elderly Subjects
- ClinicalTrials.gov ID
- NCT01089738
- Acronym / sponsor ID
- B1651003
- Conditions
- Healthy
- Keywords
- mulitple dose, pharmacokinetics, safety, healthy elderly volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2010 (actual)
- Primary completion
- 25 Apr 2011 (estimated)
- Study completion
- 25 Apr 2011 (estimated)
- First posted
- 18 Mar 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 study is designed to look at the safety and blood concentrations of PF-03382792 in healthy elderly subjects after taking multiple doses for 14 days.
Detailed description
To examine safety, toleratibilty and pharmacokinetics of PF-03382792 in healthy elderly subjects.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dosing | Experimental | Drug: PF-03382792 0.5mg, Drug: PF-03382792 1.5 mg, Drug: PF-03382792 5 mg, Drug: PF-03382792 15 mgAscending Doses |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Healthy volunteer aged 65-80 years old
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2
- Total body weight >50 kg (110 lbs).
Key exclusion criteria (3 listed)
- 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 symptoms or signs of adrenal insufficiency.
- Subjects with clinically significant ocular lens abnormalities as detected by the investigator based on the findings of a slit lamp examination performed by an ophthalmologist.
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-03382792 0.5mg0.5 mg PF-03382792, qd, for 14 days or placebo | Drug | Dosing |
| PF-03382792 1.5 mg1.5 mg PF-03382792, qd, for 14 days or placebo | Drug | Dosing |
| PF-03382792 5 mg5 mg PF-03382792, qd, for 14 days or placebo | Drug | Dosing |
| PF-03382792 15 mg15 mg PF-03382792, qd, for 14 days or placebo | Drug | Dosing |
Primary outcome
Safety Endpoints include: AEs, vital signs, triplicate ECGs,
Time frame: Day 0 to Day 28
Safety Endpoints include: Cosyntropin Stimulation Test, Clinical Examinations, Slit Lamp Examination, Aldosterone Concentrations
Time frame: Day 0 to Day 28
Safety Endpoints include: safety laboratory endpoints (including a complete blood count and a full chemistry panel, including electrolytes, hepatic transaminases, and urinalysis, with microscopic analysis if dipstick analysis is positive),
Time frame: Day 0 to Day 28
Pharmacokinetic endpoints include: Plasma concentrations of PF 03382792 and its N dealkylated metabolite, PF 03227077, will be measured and used to determine Cmax, Tmax, AUC on Day 1 and Css,max, Tss,max, AUC, Css,min, Css,avg on Days 7 and 14.
Time frame: Day 0 to Day 28
Additional pharmacokinetic endpoints: the accumulation ratio (Rac) will be determined from Day 14 and Day 1 AUC. If data permit, t1/2 and urinary excretion parameters (CLR for the parent and Ae and Ae%) will be calculated.
Time frame: Day 0 to Day 28
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2018.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests
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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
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PF-03382792 0.5mg, PF-03382792 1.5 mg and PF-03382792 5 mg in people with Healthy, run by Pfizer.
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 3 inclusion and 3 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: withdrawn, as of the sponsor's last update on 6 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Safety Endpoints include: AEs, vital signs, triplicate ECGs, (time frame: Day 0 to Day 28). 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 6 Nov 2018.