HealthyPhase 1NCT02070289
A Study to Evaluate Safety, Toleration and Time Course of Plasma Concentration of Multiple Oral Doses of PF-06372865 in Healthy Subjects of Two AgeGroups, Aged 18-55 Years (Group 1) and Aged 56-75 Years (Group 2)
A Phase 1 study testing PF-06372865 in people with Healthy, run by Pfizer at 1 site in Belgium.
Trial summary
The purpose of this study is to investigate safety, toleration and time course of plasma concentration of multiple oral doses of PF-06372865 for 14 days in healthy subjects of two age groups, 18-55 years (Group 1) and 56-75 years (Group 2). Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- PF-06372865
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- Mar 2014to Jul 2014
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For Group 1 specific: Healthy male and/or female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive at Screening. 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.
- For Group 2 specific: Male and/or female subjects of non-childbearing potential between the ages of 56 and 75 years, inclusive at Screening. 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, osteoarthritis) may be enrolled if deemed medically prudent by the Investigator. At least 50% of the subjects enrolled in these cohorts must be 60 years of age and above at Screening.
- For Group 2 specific: Subjects taking daily prescription or non-prescription medications for management of acceptable chronic medical conditions must be on a stable dose of these, as defined by non change in dose for the 3 months prior to the first dose of study medication and no planned changes during the conduct of the study.
Who cannot join
- For Group 1 specific: 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).
- For Group 2 specific : Evidence or history of unstable disease or moderate to severe conditions which would, in the Investigator's opinion, interfere with the study evaluations or impact on the safety of participating subjects, such as orthostatic hypotension.
- Subjects with history of sleep apnea
- Any condition possibly affecting drug absorption (eg, gastrectomy).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Double Blind (3rd Party Open) Randomized, Placebo Controlled, Dose Escalation Study To Investigate The Safety, Tolerability And Pharmacokinetics Of Repeat Doses Of Pf-06372865 In Subjects Aged 18-55 (Group 1) And 56-75 Years (Group 2)
The purpose of this study is to investigate safety, toleration and time course of plasma concentration of multiple oral doses of PF-06372865 for 14 days in healthy subjects of two age groups, 18-55 years (Group 1) and 56-75 years (Group 2).
- Conditions
- Healthy
- Being tested
- PF-06372865, Placebo
- Keywords
- Multiple dose, safety, tolerability, PK
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-06372865Drug
Tablets, 2.5 mg BID, 14 days
PlaceboDrug
Tablets, BID, 14 days
PF-06372865Drug
Tablets, to be decided dose, BID or titration, 14 days
PlaceboDrug
Tablets, BID or titration, 14 days
PF-06372865Drug
Tablets, to be decided dose, BID or titration, 14 days
PlaceboDrug
Tablets, BID or titration, 14 days
PF-06372865Drug
Tablets, to be decided dose, BID or titration, 14 days
PlaceboDrug
Tablets, BID or titration, 14 days
PF-06372865Drug
Tablets, to be decided dose, BID or titration, 14 days
PlaceboDrug
Tablets, BID or titration, 14 days
PF-06372865Drug
Tablets, to be decided dose, BID or titration, 14 days
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Cohort 1 | Experimental | Not described Receives: Drug: PF-06372865; Drug: Placebo |
| Group 1: Cohort 2 | Experimental | Not described Receives: Drug: PF-06372865; Drug: Placebo |
| Group 1: Cohort 3 | Experimental | Not described Receives: Drug: PF-06372865; Drug: Placebo |
| Group 2: Cohort 4 | Experimental | Not described Receives: Drug: PF-06372865; Drug: Placebo |
| Group 1 or 2: Cohort 5 | Experimental | Not described Receives: Drug: PF-06372865; Drug: Placebo |
| Group 1 or 2: Cohort 6 | Experimental | Not described Receives: Drug: PF-06372865 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Concentration (Cmax)
Measured: 14 days
Area Under the Curve from Time Zero to end of dosing interval (AUCtau)
Measured: 14 days
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2014 (estimated)
- Study startMar 2014
- Primary completionJul 2014
- Study completionJul 2014
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 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
- NCT02070289
- Sponsor's protocol ID
- B7431002
- Status last verified
- Aug 2014
- First submitted
- 20 Feb 2014
- Last updated
- 18 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Double Blind (3rd Party Open) Randomized, Placebo Controlled, Dose Escalation Study To Investigate The Safety, Tolerability And Pharmacokinetics Of Repeat Doses Of Pf-06372865 In Subjects Aged 18-55 (Group 1) And 56-75 Years (Group 2)
- ClinicalTrials.gov ID
- NCT02070289
- Acronym / sponsor ID
- B7431002
- Conditions
- Healthy
- Keywords
- Multiple dose, safety, tolerability, PK
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 25 Feb 2014 (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.
The purpose of this study is to investigate safety, toleration and time course of plasma concentration of multiple oral doses of PF-06372865 for 14 days in healthy subjects of two age groups, 18-55 years (Group 1) and 56-75 years (Group 2).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group 1: Cohort 1 | Experimental | Drug: PF-06372865, Drug: Placebo |
| Group 1: Cohort 2 | Experimental | Drug: PF-06372865, Drug: Placebo |
| Group 1: Cohort 3 | Experimental | Drug: PF-06372865, Drug: Placebo |
| Group 2: Cohort 4 | Experimental | Drug: PF-06372865, Drug: Placebo |
| Group 1 or 2: Cohort 5 | Experimental | Drug: PF-06372865, Drug: Placebo |
| Group 1 or 2: Cohort 6 | Experimental | Drug: PF-06372865 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- For Group 1 specific: Healthy male and/or female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive at Screening. 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.
- For Group 2 specific: Male and/or female subjects of non-childbearing potential between the ages of 56 and 75 years, inclusive at Screening. 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, osteoarthritis) may be enrolled if deemed medically prudent by the Investigator. At least 50% of the subjects enrolled in these cohorts must be 60 years of age and above at Screening.
- For Group 2 specific: Subjects taking daily prescription or non-prescription medications for management of acceptable chronic medical conditions must be on a stable dose of these, as defined by non change in dose for the 3 months prior to the first dose of study medication and no planned changes during the conduct of the study.
Key exclusion criteria (4 listed)
- For Group 1 specific: 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).
- For Group 2 specific : Evidence or history of unstable disease or moderate to severe conditions which would, in the Investigator's opinion, interfere with the study evaluations or impact on the safety of participating subjects, such as orthostatic hypotension.
- Subjects with history of sleep apnea
- Any condition possibly affecting drug absorption (eg, gastrectomy).
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-06372865Tablets, 2.5 mg BID, 14 days | Drug | Group 1: Cohort 1 |
| PlaceboTablets, BID, 14 days | Drug | Group 1: Cohort 1 |
| PF-06372865Tablets, to be decided dose, BID or titration, 14 days | Drug | Group 1: Cohort 2 |
| PlaceboTablets, BID or titration, 14 days | Drug | Group 1: Cohort 2 |
| PF-06372865Tablets, to be decided dose, BID or titration, 14 days | Drug | Group 1: Cohort 3 |
| PlaceboTablets, BID or titration, 14 days | Drug | Group 1: Cohort 3 |
| PF-06372865Tablets, to be decided dose, BID or titration, 14 days | Drug | Group 2: Cohort 4 |
| PlaceboTablets, BID or titration, 14 days | Drug | Group 2: Cohort 4 |
| PF-06372865Tablets, to be decided dose, BID or titration, 14 days | Drug | Group 1 or 2: Cohort 5 |
| PlaceboTablets, BID or titration, 14 days | Drug | Group 1 or 2: Cohort 5 |
| PF-06372865Tablets, to be decided dose, BID or titration, 14 days | Drug | Group 1 or 2: Cohort 6 |
Primary outcome
Maximum Observed Plasma Concentration (Cmax)
Time frame: 14 days
Area Under the Curve from Time Zero to end of dosing interval (AUCtau)
Time frame: 14 days
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: 14 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 18 Aug 2014.
- 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-06372865 in people with Healthy, run by Pfizer at 1 site in Belgium.
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 4 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 18 Aug 2014. 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 Belgium. 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?
Maximum Observed Plasma Concentration (Cmax) (time frame: 14 days). The study lists 3 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 18 Aug 2014.