HealthyPhase 1NCT03126149
First in Human Study for PF-06667272
A Phase 1 study testing PF-06667272 in people with Healthy, run by Pfizer at 1 site in Belgium.
Trial summary
The current study is the first clinical trial proposed with PF-06667272. It is designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of single ascending doses of PF-06667272 under fed and fasted conditions, in healthy adult subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- PF-06667272
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteBelgium
- Study dates
- 11 May 2017to 5 Sep 2017
- 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 males and female of non-childbearing potential;
- Body Mass Index 17.5-30.5 kg/m2;
- Body weight >50 kg;
Who cannot join
- Evidence of 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-blind (Sponsor-open), Placebo-controlled Study To Assess The Safety, Tolerability, And Pharmacokinetics Of Single Escalating Oral Doses Of Pf-06667272 Under Fed And Fasted Conditions, In Healthy Adult Subjects
The current study is the first clinical trial proposed with PF-06667272. It is designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of single ascending doses of PF-06667272 under fed and fasted conditions, in healthy adult subjects.
- Conditions
- Healthy
- Being tested
- PF-06667272, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-06667272Drug
Single ascending dose of PF-06667272
PlaceboOther
Single dose of placebo
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1_Period 1_Active | Experimental | Single ascending dose of PF-06667272 Receives: Drug: PF-06667272 |
| Cohort 1_Period 1_Placebo | Placebo comparator | Single dose of placebo Receives: Other: Placebo |
| Cohort 1_Period 2_Active | Experimental | Single ascending dose of PF-06667272 Receives: Drug: PF-06667272 |
| Cohort 1_Period 2_Placebo | Placebo comparator | Single dose of placebo Receives: Other: Placebo |
| Cohort 1_Period 3_Active | Experimental | Single ascending dose of PF-06667272 Receives: Drug: PF-06667272 |
| Cohort 1_Period 3_Placebo | Placebo comparator | Single dose of placebo Receives: Other: Placebo |
| Cohrot 1_Period 4_Active | Experimental | Single ascending dose of PF-06667272 Receives: Drug: PF-06667272 |
| Cohort 1_Period 4_Placebo | Placebo comparator | Single dose of placebo Receives: Other: Placebo |
| Cohort 2_Period 1_Active | Experimental | Single ascending dose of PF-06667272 Receives: Drug: PF-06667272 |
| Cohort 2_Period 1_Placebo | Placebo comparator | Single dose of placebo Receives: Other: Placebo |
| Cohort 2_Period 2_Active | Experimental | Single ascending dose of PF-06667272 Receives: Drug: PF-06667272 |
| Cohort 2_Period 2_Placebo | Placebo comparator | Single dose of placebo Receives: Other: Placebo |
| Cohort 2_Period 3_Active | Experimental | Single ascending dose of PF-06667272 Receives: Drug: PF-06667272 |
| Cohort 2_Period 3_Placebo | Placebo comparator | Single dose of placebo Receives: Other: Placebo |
| Cohort 2_Period 4_Active | Experimental | Single ascending dose of PF-06667272 Receives: Drug: PF-06667272 |
| Cohort 2_Period 4_Placebo | Placebo comparator | Single dose of placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Treatment Emergent Treatment-Related Adverse Events (AEs) or other safety concerns
Assessment by adverse event monitoring, 12 lead ECGs, telemetry, vital signs and clinical safety laboratory measurements.
Treatment-related AE was any untoward medical occurrence attributed to study drug in a subject who received study drug. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to Drug was assessed by the investigator (Yes/No). Subjects with multiple occurrences of an AE within a category were counted once within the category.
Measured: Baseline (Day 1, hour 0) up to 28 days after last dose of study medication
Secondary outcomes (7)
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06667272 and PF-06818073
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Measured: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0- infinity)] for PF-06667272 and PF-06818073 (as permitted)
AUC (0-infinity)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-infinity). It is obtained from AUC (0-t) plus AUC (t-infinity).
Measured: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose
Maximum Observed Plasma Concentration (Cmax) for PF-06667272 and PF-06818073
Maximum Observed Plasma Concentration (Cmax)
Measured: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose
Time to Reach Maximum Observed Concentration for PF-06667272 and PF-06818073
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Measured: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose
Plasma Decay Half-Life (t1/2) for PF-06667272 and PF-06818073
Plasma Decay Half-Life (t1/2)
Measured: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose
Apparent Total Body Clearance (CL/F) for PF-06667272
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after apparent total body clearance is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Measured: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose
Apparent Volume of Distribution (Vz/F) for PF-06667272
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
Measured: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2017
- Study start11 May 2017
- Primary completion5 Sep 2017
- Study completion5 Sep 2017
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
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 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
- NCT03126149
- Sponsor's protocol ID
- C0231002
- Other IDs
- 2017-000590-36, 2017
- Status last verified
- Oct 2017
- First submitted
- 19 Apr 2017
- Last updated
- 19 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- 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 19 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-blind (Sponsor-open), Placebo-controlled Study To Assess The Safety, Tolerability, And Pharmacokinetics Of Single Escalating Oral Doses Of Pf-06667272 Under Fed And Fasted Conditions, In Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT03126149
- Acronym / sponsor ID
- C0231002
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 11 May 2017 (actual)
- Primary completion
- 5 Sep 2017 (actual)
- Study completion
- 5 Sep 2017 (actual)
- First posted
- 24 Apr 2017 (actual)
- 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 current study is the first clinical trial proposed with PF-06667272. It is designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of single ascending doses of PF-06667272 under fed and fasted conditions, in healthy adult subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 16
| Arm | Type | Receives |
|---|---|---|
| Cohort 1_Period 1_Active | Experimental | Drug: PF-06667272Single ascending dose of PF-06667272 |
| Cohort 1_Period 1_Placebo | Placebo comparator | Other: PlaceboSingle dose of placebo |
| Cohort 1_Period 2_Active | Experimental | Drug: PF-06667272Single ascending dose of PF-06667272 |
| Cohort 1_Period 2_Placebo | Placebo comparator | Other: PlaceboSingle dose of placebo |
| Cohort 1_Period 3_Active | Experimental | Drug: PF-06667272Single ascending dose of PF-06667272 |
| Cohort 1_Period 3_Placebo | Placebo comparator | Other: PlaceboSingle dose of placebo |
| Cohrot 1_Period 4_Active | Experimental | Drug: PF-06667272Single ascending dose of PF-06667272 |
| Cohort 1_Period 4_Placebo | Placebo comparator | Other: PlaceboSingle dose of placebo |
| Cohort 2_Period 1_Active | Experimental | Drug: PF-06667272Single ascending dose of PF-06667272 |
| Cohort 2_Period 1_Placebo | Placebo comparator | Other: PlaceboSingle dose of placebo |
| Cohort 2_Period 2_Active | Experimental | Drug: PF-06667272Single ascending dose of PF-06667272 |
| Cohort 2_Period 2_Placebo | Placebo comparator | Other: PlaceboSingle dose of placebo |
| Cohort 2_Period 3_Active | Experimental | Drug: PF-06667272Single ascending dose of PF-06667272 |
| Cohort 2_Period 3_Placebo | Placebo comparator | Other: PlaceboSingle dose of placebo |
| Cohort 2_Period 4_Active | Experimental | Drug: PF-06667272Single ascending dose of PF-06667272 |
| Cohort 2_Period 4_Placebo | Placebo comparator | Other: PlaceboSingle dose of placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy males and female of non-childbearing potential;
- Body Mass Index 17.5-30.5 kg/m2;
- Body weight >50 kg;
Key exclusion criteria (1 listed)
- Evidence of 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)
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-06667272Single ascending dose of PF-06667272 | Drug | Cohort 1_Period 1_Active, Cohort 1_Period 2_Active, Cohort 1_Period 3_Active, Cohort 2_Period 1_Active, Cohort 2_Period 2_Active, Cohort 2_Period 3_Active, Cohort 2_Period 4_Active, Cohrot 1_Period 4_Active |
| PlaceboSingle dose of placebo | Other | Cohort 1_Period 1_Placebo, Cohort 1_Period 2_Placebo, Cohort 1_Period 3_Placebo, Cohort 1_Period 4_Placebo, Cohort 2_Period 1_Placebo, Cohort 2_Period 2_Placebo, Cohort 2_Period 3_Placebo, Cohort 2_Period 4_Placebo |
Primary outcome
Number of Subjects With Treatment Emergent Treatment-Related Adverse Events (AEs) or other safety concerns
Time frame: Baseline (Day 1, hour 0) up to 28 days after last dose of study medication
Assessment by adverse event monitoring, 12 lead ECGs, telemetry, vital signs and clinical safety laboratory measurements. Treatment-related AE was any untoward medical occurrence attributed to study drug in a subject who received study drug. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to Drug was assessed by the investigator (Yes/No). Subjects with multiple occurrences of an AE within a category were counted once within the category.
7 secondary outcomes
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06667272 and PF-06818073
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0- infinity)] for PF-06667272 and PF-06818073 (as permitted)
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose
Maximum Observed Plasma Concentration (Cmax) for PF-06667272 and PF-06818073
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose
Time to Reach Maximum Observed Concentration for PF-06667272 and PF-06818073
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose
Plasma Decay Half-Life (t1/2) for PF-06667272 and PF-06818073
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose
Apparent Total Body Clearance (CL/F) for PF-06667272
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose
Apparent Volume of Distribution (Vz/F) for PF-06667272
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post 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 19 Oct 2017.
- 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
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-06667272 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 1 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 19 Oct 2017. 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. 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 Subjects With Treatment Emergent Treatment-Related Adverse Events (AEs) or other safety concerns (time frame: Baseline (Day 1, hour 0) up to 28 days after last dose of study medication). 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 19 Oct 2017.