HealthyPhase 1NCT02237742
A Study To Understand How The Body Reacts To A Low Dose Of PF-06427878 When Given In A Vein To Healthy, Adult, Males
A Phase 1 study testing PF-06427878 in people with Healthy, run by Pfizer at 1 site in United Kingdom.
Trial summary
To determine how the body reacts to a low dose of PF-06427878 when given in a vein over 30 minutes to healthy, adult, males. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- PF-06427878
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2014to Dec 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects between 18-55 years of age
- BMI of 17.5-30.5 kg/m2
Who cannot join
- History of drug or alcohol abuse within 2 years of screening
- Subjects without suitable veins for multiple venipuncture/cannulation
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Quotient Clinical Ltd
Ruddington, Nottingham, NG11 6JS
About this study
Official title: A Phase 1, Non-Randomized, Open-Label, Single-Dose, Single Period Study With Non-Pharmacologically Active Dose Of Pf-06427878 To Characterize Pharmacokinetics Following Intravenous Administration In Healthy, Adult, Male Subjects
To determine how the body reacts to a low dose of PF-06427878 when given in a vein over 30 minutes to healthy, adult, males.
- Conditions
- Healthy
- Being tested
- PF-06427878
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-06427878Drug
Intravenous, 100 micrograms, single dose, 30 minute infusion
| Study group | Role | What they receive |
|---|---|---|
| PF-06427878 | Experimental | Not described Receives: Drug: PF-06427878 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Plasma Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Measured: Day 1 Min 0,5,15,30,35,45,60,75,90, Hr 2,2.5,3.5,4.5,5.5,6.5,8.5,10.5,12.5,24.5
Area under the Plasma Concentration-Time Curve From Time Zero extrapolated to Infinite Time (AUCinf)
Measured: Day 1 Min 0,5,15,30,35,45,60,75,90, Hr 2,2.5,3.5,4.5,5.5,6.5,8.5,10.5,12.5,24.5
Maximum Observed Plasma Concentration (Cmax)
Measured: Day 1 Min 0,5,15,30,35,45,60,75,90, Hr 2,2.5,3.5,4.5,5.5,6.5,8.5,10.5,12.5,24.5
Plasma Terminal Elimination Half Life (t1/2)
Measured: Day 1 Min 0,5,15,30,35,45,60,75,90, Hr 2,2.5,3.5,4.5,5.5,6.5,8.5,10.5,12.5,24.5
Plasma Systemic Clearance (CL)
Measured: Day 1 Min 0,5,15,30,35,45,60,75,90, Hr 2,2.5,3.5,4.5,5.5,6.5,8.5,10.5,12.5,24.5
Plasma Volume of Distribution at Steady State (Vss)
Measured: Day 1 Min 0,5,15,30,35,45,60,75,90, Hr 2,2.5,3.5,4.5,5.5,6.5,8.5,10.5,12.5,24.5
Secondary outcomes (3)
Amount of unchanged drug excreted in urine from time 0 to 12.5 hours (Ae12.5)
Measured: Day 1 Hr 0 to 12.5
Percent of dose excreted in urine as unchanged drug from time zero to 12.5 hours (Ae12.5%)
Measured: Day 1 Hr 0 to 12.5
Renal clearance (CLr)
Measured: Day 1 Hr 0 to 12.5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2014 (estimated)
- Study startNov 2014
- Primary completionNov 2014
- Study completionDec 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 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
- NCT02237742
- Sponsor's protocol ID
- B7871004
- Other IDs
- 2014-002626-12, 2014
- Status last verified
- Nov 2018
- First submitted
- 9 Sep 2014
- Last updated
- 14 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Non-Randomized, Open-Label, Single-Dose, Single Period Study With Non-Pharmacologically Active Dose Of Pf-06427878 To Characterize Pharmacokinetics Following Intravenous Administration In Healthy, Adult, Male Subjects
- ClinicalTrials.gov ID
- NCT02237742
- Acronym / sponsor ID
- B7871004
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Nov 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 11 Sep 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.
To determine how the body reacts to a low dose of PF-06427878 when given in a vein over 30 minutes to healthy, adult, males.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PF-06427878 | Experimental | Drug: PF-06427878 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy male subjects between 18-55 years of age
- BMI of 17.5-30.5 kg/m2
Key exclusion criteria (2 listed)
- History of drug or alcohol abuse within 2 years of screening
- Subjects without suitable veins for multiple venipuncture/cannulation
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-06427878Intravenous, 100 micrograms, single dose, 30 minute infusion | Drug | PF-06427878 |
Primary outcome
Area Under the Plasma Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Time frame: Day 1 Min 0,5,15,30,35,45,60,75,90, Hr 2,2.5,3.5,4.5,5.5,6.5,8.5,10.5,12.5,24.5
Area under the Plasma Concentration-Time Curve From Time Zero extrapolated to Infinite Time (AUCinf)
Time frame: Day 1 Min 0,5,15,30,35,45,60,75,90, Hr 2,2.5,3.5,4.5,5.5,6.5,8.5,10.5,12.5,24.5
Maximum Observed Plasma Concentration (Cmax)
Time frame: Day 1 Min 0,5,15,30,35,45,60,75,90, Hr 2,2.5,3.5,4.5,5.5,6.5,8.5,10.5,12.5,24.5
Plasma Terminal Elimination Half Life (t1/2)
Time frame: Day 1 Min 0,5,15,30,35,45,60,75,90, Hr 2,2.5,3.5,4.5,5.5,6.5,8.5,10.5,12.5,24.5
Plasma Systemic Clearance (CL)
Time frame: Day 1 Min 0,5,15,30,35,45,60,75,90, Hr 2,2.5,3.5,4.5,5.5,6.5,8.5,10.5,12.5,24.5
Plasma Volume of Distribution at Steady State (Vss)
Time frame: Day 1 Min 0,5,15,30,35,45,60,75,90, Hr 2,2.5,3.5,4.5,5.5,6.5,8.5,10.5,12.5,24.5
3 secondary outcomes
Amount of unchanged drug excreted in urine from time 0 to 12.5 hours (Ae12.5)
Time frame: Day 1 Hr 0 to 12.5
Percent of dose excreted in urine as unchanged drug from time zero to 12.5 hours (Ae12.5%)
Time frame: Day 1 Hr 0 to 12.5
Renal clearance (CLr)
Time frame: Day 1 Hr 0 to 12.5
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 14 Nov 2018.
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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-06427878 in people with Healthy, run by Pfizer at 1 site in United Kingdom.
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 2 inclusion and 2 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 14 Nov 2018. 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 United Kingdom. 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?
Area Under the Plasma Curve From Time Zero to Last Quantifiable Concentration (AUClast) (time frame: Day 1 Min 0,5,15,30,35,45,60,75,90, Hr 2,2.5,3.5,4.5,5.5,6.5,8.5,10.5,12.5,24.5). The study lists 6 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 14 Nov 2018.