HealthyPhase 1NCT01951144
A First In Human Study In Healthy People To Evaluate Safety, Toleration, Pharmacokinetics and Pharmacodynamics of Single Oral Doses Of PF-06372865
A Phase 1 study of Healthy, run by Pfizer at 1 site in Netherlands.
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-06372865. The pharmacodynamic activity of PF-06372865 will also be assessed. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2013to 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 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.
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, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-06372865 in Healthy Male and Female Subjects
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-06372865. The pharmacodynamic activity of PF-06372865 will also be assessed. The effect of food on PK and the PK of PF-06372865 administered as a tablet formulation may also be investigated. Pharmacodynamic interaction between PF-06372865 and lorazepam will be evaluated.
- Conditions
- Healthy
- Being tested
- PF-06372865 or Placebo, PF-06372865 or Placebo or Lorazepam
- Keywords
- Phase 1, Single Dose, Pharmacokinetics, Safety, Toleration, Pharmacodynamics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-06372865 or PlaceboDrug
PF-06372865 will be administered as an extemporaneously prepared solution for all doses unless the tablet formulation need to be evaluated. Correspondingly, placebo doses will be administered as solution or tablet.
PF-06372865 or PlaceboDrug
PF-06372865 will be administered as an extemporaneously prepared solution for all doses unless the tablet formulation need to be evaluated. Correspondingly, placebo doses will be administered as solution or tablet.
PF-06372865 or PlaceboDrug
PF-06372865 will be administered as an extemporaneously prepared solution for all doses unless the tablet formulation need to be evaluated. Correspondingly, placebo doses will be administered as solution or tablet.
PF-06372865 or Placebo or LorazepamDrug
Lorazepam 2 mg dose, PF-06372865 Dose 1, PF-06372865 Dose 2, PF-06372865 Dose 1 and Dose 2 in combination with lorazepam, placebo administered as tablet formulation
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: | Experimental | Single ascending doses of PF-06372865 or placebo to investigate the safety/tolerability PK and PD of PF-06372865. Receives: Drug: PF-06372865 or Placebo |
| Cohort 2: | Experimental | Single ascending doses of PF-06372865 or placebo to investigate the safety/tolerability PK and PD of PF-06372865. Receives: Drug: PF-06372865 or Placebo |
| Cohort 3: | Experimental | Single ascending doses of PF-06372865 or placebo to investigate the safety/tolerability PK and PD of PF-06372865. Receives: Drug: PF-06372865 or Placebo |
| Cohort 4 (optional cohort): | Experimental | Two single doses of PF-06372865 or placebo or lorazepam to further investigate the pharmacodynamics of PF-06372865. Receives: Drug: PF-06372865 or Placebo or Lorazepam |
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, 16, 24, 36, 48, 72, 96 hours post-dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Measured: 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours post-dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time
Measured: 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours post-dose
Apparent Oral Clearance (CL/F)
Measured: 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours post-dose
Apparent Volume of Distribution (Vz/F)
Measured: 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours post-dose
Plasma Decay Half-Life (t1/2)
Measured: 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours post-dose
Area Under the Curve From Time Zero to 24 hours
Measured: 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours post-dose
Change in Saccadic Eye Movements (saccadic reaction time, saccadic peak velocity and saccadic inaccuracy)
Measured: 0, 0.5, 1, 1.5, 2, 4, 6, 12 hours post-dose
Change in Body Sway
Measured: 0, 0.5, 1, 1.5, 2, 4, 6, 12 hours post-dose
Change in Smooth Pursuit
Measured: 0, 0.5, 1, 1.5, 2, 4, 6, 12 hours post-dose
Change in Bond and Lader VAS
Measured: 0, 0.5, 1, 1.5, 2, 4, 6, 12 hours post-dose
Change in Adaptive Tracking
Measured: 0, 0.5, 1, 1.5, 2, 4, 6, 12 hours post-dose
Change in Visual Verbal Learning Test
Measured: 1 and 6 hours post dose
Change in Pharmaco-EEG
Measured: 0, 0.5, 1, 1.5, 2, 4, 6, 12 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 posted26 Sep 2013 (estimated)
- Study startOct 2013
- 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 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
- NCT01951144
- Sponsor's protocol ID
- B7431001
- Status last verified
- Aug 2014
- First submitted
- 13 Sep 2013
- 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 Double Blind (3rd Party Open) Randomized, Placebo Controlled, Crossover Dose Escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-06372865 in Healthy Male and Female Subjects
- ClinicalTrials.gov ID
- NCT01951144
- Acronym / sponsor ID
- B7431001
- Conditions
- Healthy
- Keywords
- Phase 1, Single Dose, Pharmacokinetics, Safety, Toleration, Pharmacodynamics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 26 Sep 2013 (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-06372865. The pharmacodynamic activity of PF-06372865 will also be assessed. The effect of food on PK and the PK of PF-06372865 administered as a tablet formulation may also be investigated. Pharmacodynamic interaction between PF-06372865 and lorazepam will be evaluated.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: | Experimental | Drug: PF-06372865 or PlaceboSingle ascending doses of PF-06372865 or placebo to investigate the safety/tolerability PK and PD of PF-06372865. |
| Cohort 2: | Experimental | Drug: PF-06372865 or PlaceboSingle ascending doses of PF-06372865 or placebo to investigate the safety/tolerability PK and PD of PF-06372865. |
| Cohort 3: | Experimental | Drug: PF-06372865 or PlaceboSingle ascending doses of PF-06372865 or placebo to investigate the safety/tolerability PK and PD of PF-06372865. |
| Cohort 4 (optional cohort): | Experimental | Drug: PF-06372865 or Placebo or LorazepamTwo single doses of PF-06372865 or placebo or lorazepam to further investigate the pharmacodynamics of PF-06372865. |
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 (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).
- Any condition possibly affecting drug absorption (e.g., gastrectomy).
- A positive urine drug screen.
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-06372865 or PlaceboPF-06372865 will be administered as an extemporaneously prepared solution for all doses unless the tablet formulation need to be evaluated. Correspondingly, placebo doses will be administered as solution or tablet. | Drug | Cohort 1: |
| PF-06372865 or PlaceboPF-06372865 will be administered as an extemporaneously prepared solution for all doses unless the tablet formulation need to be evaluated. Correspondingly, placebo doses will be administered as solution or tablet. | Drug | Cohort 2: |
| PF-06372865 or PlaceboPF-06372865 will be administered as an extemporaneously prepared solution for all doses unless the tablet formulation need to be evaluated. Correspondingly, placebo doses will be administered as solution or tablet. | Drug | Cohort 3: |
| PF-06372865 or Placebo or LorazepamLorazepam 2 mg dose, PF-06372865 Dose 1, PF-06372865 Dose 2, PF-06372865 Dose 1 and Dose 2 in combination with lorazepam, placebo administered as tablet formulation | Drug | Cohort 4 (optional cohort): |
Primary outcome
Maximum Observed Plasma Concentration (Cmax)
Time frame: 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours post-dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Time frame: 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours post-dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time
Time frame: 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours post-dose
Apparent Oral Clearance (CL/F)
Time frame: 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours post-dose
Apparent Volume of Distribution (Vz/F)
Time frame: 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours post-dose
Plasma Decay Half-Life (t1/2)
Time frame: 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours post-dose
Area Under the Curve From Time Zero to 24 hours
Time frame: 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours post-dose
Change in Saccadic Eye Movements (saccadic reaction time, saccadic peak velocity and saccadic inaccuracy)
Time frame: 0, 0.5, 1, 1.5, 2, 4, 6, 12 hours post-dose
Change in Body Sway
Time frame: 0, 0.5, 1, 1.5, 2, 4, 6, 12 hours post-dose
Change in Smooth Pursuit
Time frame: 0, 0.5, 1, 1.5, 2, 4, 6, 12 hours post-dose
Change in Bond and Lader VAS
Time frame: 0, 0.5, 1, 1.5, 2, 4, 6, 12 hours post-dose
Change in Adaptive Tracking
Time frame: 0, 0.5, 1, 1.5, 2, 4, 6, 12 hours post-dose
Change in Visual Verbal Learning Test
Time frame: 1 and 6 hours post dose
Change in Pharmaco-EEG
Time frame: 0, 0.5, 1, 1.5, 2, 4, 6, 12 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 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 of Healthy, run by Pfizer at 1 site in Netherlands.
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 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: 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 Netherlands. 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, 16, 24, 36, 48, 72, 96 hours post-dose). The study lists 14 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.