PAINPhase 1NCT01601834
A First In Human Study In Healthy People To Evaluate Safety, Toleration And Time Course Of Plasma Concentration Of Single Oral Doses Of PF-06273340
A Phase 1 study of PAIN, run by Pfizer at 1 site in Belgium.
Trial summary
The purpose of this study in healthy people is to evaluate safety, toleration and time course of plasma concentration of single oral doses of PF-06273340. The effect of food on the Pharmacokinetic of PF-06273340 may also be investigated. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- PAIN
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- May 2012to Jun 2012
- 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 male subjects or female subjects of non-child bearing potential between the ages of 18 and 55 years, inclusive.
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
- An informed consent document signed and dated by the subject
- Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
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).
- Any condition possibly affecting drug absorption (e.g., gastrectomy).
- A positive urine drug screen.
- History of regular alcohol consumption exceeding 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.
- Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication.
- Screening supine blood pressure >= 140 mm Hg (systolic) or >= 90 mm Hg (diastolic), on a single measurement (confirmed by a single repeat, if necessary) following at least 5 minutes of rest.
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- 12-lead ECG demonstrating QTc >450 msec at screening. If QTc exceeds 450 msec, the ECG should be repeated two more times and the average of the three QTc values should be used to determine the subject's eligibility.
- Females of child bearing potential.
- Use of prescription or non-prescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication. Herbal supplements must be discontinued 28 days prior to the first dose of study medication. As an exception, acetaminophen/paracetamol may be used at doses of 1 g/day. Limited use of non-prescription medications that are not believed to affect subject safety or the overall results of the study may be permitted on a case-by-case basis following approval by the sponsor.
- Blood donation of approximately 1 pint (500 mL) within 56 days prior to dosing. History of sensitivity to heparin or heparin-induced thrombocytopenia.
- Unwilling or unable to comply with the Lifestyle guidelines described in this protocol.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double Blind (3rd Party Open) Randomized, Placebo Controlled, Crossover Dose Escalation Study To Investigate The Safety, Toleration And Pharmacokinetics Of Pf-06273340 In Healthy Volunteers
The purpose of this study in healthy people is to evaluate safety, toleration and time course of plasma concentration of single oral doses of PF-06273340. The effect of food on the Pharmacokinetic of PF-06273340 may also be investigated.
- Conditions
- PAIN
- Being tested
- PF-06273340 or Placebo
- Keywords
- Phase 1, Single Dose, Pharmacokinetics, Safety, Toleration
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-06273340 or PlaceboDrug
PF-06273340 will be administered as an extemporaneously prepared solution for all doses. Correspondingly, placebo doses will be administered as solution.
PF-06273340 or PlaceboDrug
PF-06273340 will be administered as an extemporaneously prepared solution for all doses. Correspondingly, placebo doses will be administered as solution.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Experimental intervention: PF-06273340 or placebo | Experimental | Subjects in Cohort 1 will receive single ascending doses of PF-06273340 or placebo to investigate the safety/tolerability and PK of PF-06273340. The effect of food on PK may also be investigated. Receives: Drug: PF-06273340 or Placebo |
| Cohort 2: Experimental intervention: PF-06273340 or placebo | Experimental | Subjects in Cohort 2 will receive single ascending doses of PF-06273340 or placebo to investigate the safety/tolerability and PK of PF-06273340. The effect of food on PK may also be investigated. Receives: Drug: PF-06273340 or Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration (Cmax)
Measured: 0,0.25,0.5,1,1.5,2,4,6,8,12,24,36,48,72 hours post-dose
Time of maximum concentration (Tmax)
Measured: 0,0.25,0.5,1,1.5,2,4,6,8,12,24,36,48,72 hours post-dose
Area under the plasma concentration time profile from time zero to the time of last quantifiable concentration (AUClast)
Measured: 0,0.25,0.5,1,1.5,2,4,6,8,12,24,36,48,72 hours post-dose
Area under the plasma concentration time profile from time zero extrapolated to inifinite time (AUCinf)
Measured: 0,0.25,0.5,1,1.5,2,4,6,8,12,24,36,48,72 hours post-dose
Area under the plasma concentration time profile from time zero to quantifiable concentration 24 h post dose (AUC24)
Measured: 0,0.25,0.5,1,1.5,2,4,6,8,12,24,36,48,72 hours post-dose
Apparent Clearance (CL/F)
Measured: 0,0.25,0.5,1,1.5,2,4,6,8,12,24,36,48,72 hours post-dose
Apparent Volume of Distribution (Vz/F)
Measured: 0,0.25,0.5,1,1.5,2,4,6,8,12,24,36,48,72 hours post-dose
t1/2 = Terminal Elimination half life
Measured: 0,0.25,0.5,1,1.5,2,4,6,8,12,24,36,48,72 hours post-dose
Urine: Ae24 (amount excreted in urine), Ae24% (%dose excreted in urine to time 24 h) and CLr (Renal Clearance) for selected doses
Measured: up to 24 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2012 (estimated)
- Study startMay 2012
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PAINStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
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
- NCT01601834
- Sponsor's protocol ID
- B5261001
- Status last verified
- Jul 2012
- First submitted
- 27 Apr 2012
- Last updated
- 4 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind (3rd Party Open) Randomized, Placebo Controlled, Crossover Dose Escalation Study To Investigate The Safety, Toleration And Pharmacokinetics Of Pf-06273340 In Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01601834
- Acronym / sponsor ID
- B5261001
- Conditions
- PAIN
- Keywords
- Phase 1, Single Dose, Pharmacokinetics, Safety, Toleration
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 18 May 2012 (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 in healthy people is to evaluate safety, toleration and time course of plasma concentration of single oral doses of PF-06273340. The effect of food on the Pharmacokinetic of PF-06273340 may also be investigated.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Experimental intervention: PF-06273340 or placebo | Experimental | Drug: PF-06273340 or PlaceboSubjects in Cohort 1 will receive single ascending doses of PF-06273340 or placebo to investigate the safety/tolerability and PK of PF-06273340. The effect of food on PK may also be investigated. |
| Cohort 2: Experimental intervention: PF-06273340 or placebo | Experimental | Drug: PF-06273340 or PlaceboSubjects in Cohort 2 will receive single ascending doses of PF-06273340 or placebo to investigate the safety/tolerability and PK of PF-06273340. The effect of food on PK may also be investigated. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male subjects or female subjects of non-child bearing potential between the ages of 18 and 55 years, inclusive.
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
- An informed consent document signed and dated by the subject
- Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Key exclusion criteria (12 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).
- Any condition possibly affecting drug absorption (e.g., gastrectomy).
- A positive urine drug screen.
- History of regular alcohol consumption exceeding 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.
- Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication.
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-06273340 or PlaceboPF-06273340 will be administered as an extemporaneously prepared solution for all doses. Correspondingly, placebo doses will be administered as solution. | Drug | Cohort 1: Experimental intervention: PF-06273340 or placebo |
| PF-06273340 or PlaceboPF-06273340 will be administered as an extemporaneously prepared solution for all doses. Correspondingly, placebo doses will be administered as solution. | Drug | Cohort 2: Experimental intervention: PF-06273340 or placebo |
Primary outcome
Maximum observed plasma concentration (Cmax)
Time frame: 0,0.25,0.5,1,1.5,2,4,6,8,12,24,36,48,72 hours post-dose
Time of maximum concentration (Tmax)
Time frame: 0,0.25,0.5,1,1.5,2,4,6,8,12,24,36,48,72 hours post-dose
Area under the plasma concentration time profile from time zero to the time of last quantifiable concentration (AUClast)
Time frame: 0,0.25,0.5,1,1.5,2,4,6,8,12,24,36,48,72 hours post-dose
Area under the plasma concentration time profile from time zero extrapolated to inifinite time (AUCinf)
Time frame: 0,0.25,0.5,1,1.5,2,4,6,8,12,24,36,48,72 hours post-dose
Area under the plasma concentration time profile from time zero to quantifiable concentration 24 h post dose (AUC24)
Time frame: 0,0.25,0.5,1,1.5,2,4,6,8,12,24,36,48,72 hours post-dose
Apparent Clearance (CL/F)
Time frame: 0,0.25,0.5,1,1.5,2,4,6,8,12,24,36,48,72 hours post-dose
Apparent Volume of Distribution (Vz/F)
Time frame: 0,0.25,0.5,1,1.5,2,4,6,8,12,24,36,48,72 hours post-dose
t1/2 = Terminal Elimination half life
Time frame: 0,0.25,0.5,1,1.5,2,4,6,8,12,24,36,48,72 hours post-dose
Urine: Ae24 (amount excreted in urine), Ae24% (%dose excreted in urine to time 24 h) and CLr (Renal Clearance) for selected doses
Time frame: up to 24 h
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 4 Jul 2012.
- 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 of PAIN, 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 4 inclusion and 12 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 4 Jul 2012. 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: 0,0.25,0.5,1,1.5,2,4,6,8,12,24,36,48,72 hours post-dose). The study lists 9 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 4 Jul 2012.