HealthyPhase 1NCT02537002
Single Dose Study of PF-05230907 in Healthy Japanese Subjects
A Phase 1 study testing PF-05230907 in people with Healthy, run by Pfizer at 1 site in United States.
Trial summary
The purpose of this study is the following: To determine the safety and tolerability of single ascending intravenous (IV) doses of PF-05230907 in healthy Japanese subjects. To characterize the PK profile of single ascending IV doses of PF-05230907 in healthy Japanese subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- PF-05230907
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to Mar 2016
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male of females
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs) and <120 kg (265 lbs).
- Japanese subjects who have four biologic Japanese grandparents born in Japan.
Who cannot join
- Pregnant or nursing females.
- Females of childbearing potential who are unwilling or unable to use an acceptable method of contraception.
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Pfizer New Haven Clinical Research Unit
New Haven, Connecticut, 06511-5473
About this study
Official title: A Phase 1, Randomized, Double-blind, Sponsor-open, Placebo-controlled, Single Ascending Dose Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of An Intravenous Bolus Infusion Pf-05230907 In Healthy Japanese Subjects
The purpose of this study is the following:
- To determine the safety and tolerability of single ascending intravenous (IV) doses of PF-05230907 in healthy Japanese subjects.
- To characterize the PK profile of single ascending IV doses of PF-05230907 in healthy Japanese subjects.
- To characterize the PD profiles of single ascending IV doses of PF-05230907 in healthy Japanese subjects.
- To evaluate the immunogenicity of PF-05230907 in healthy Japanese subjects
- Conditions
- Healthy
- Being tested
- PF-05230907, Placebo
- Keywords
- PF-05230907, Pharmacokinetics, Pharmacodynamic, Immunogenicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-05230907Drug
A single intravenous dose of 3 μg/kg
PF-05230907Drug
A single intravenous dose of 5 μg/kg
PlaceboDrug
A single intravenous dose of matched placebo
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1- PF-05230907 or Placebo | Experimental | Not described Receives: Drug: PF-05230907; Drug: Placebo |
| Cohort 2- PF-05230907 or Placebo | Experimental | Not described Receives: Drug: PF-05230907; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events and Serious Adverse Events Per Participant of PF-05230907
Measured: up to 2 months
Secondary outcomes (13)
Single dose Time to Reach maximum Observed Plasma Concentration (Tmax) of PF-05230907
Measured: Minute 0, 2, 5, 15, 40, 60 minute post-dose
Single dose Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]of PF-05230907
Measured: Minute 0, 2, 5, 15, 40, 60 minute post-dose
Single dose Plasma Decay Half-Life (t1/2) of PF-05230907
Measured: Minute 0, 2, 5, 15, 40, 60 minute post-dose
Single dose steady state Volume of Distribution (Vss) of PF-05230907
Measured: Minute 0, 2, 5, 15, 40, 60 minute post-dose
Single dose clearance (CL) of PF-05230907
Measured: Minute 0, 2, 5, 15, 40, 60 minute post-dose
Single dose Maximum Observed plasma concentration (Cmax) of PF-05230907
Measured: Minute 0, 2, 5, 15, 40, 60 minute post-dose
Single dose Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (last)]of PF-05230907
Measured: Minute 0, 2, 5, 15, 40, 60 minute post-dose
Change of aPTT from pre-dose to post-dose
Measured: Hour 0, 24 hour post-dose
Change of prothrombin fragments 1+2 (PF1+2)
Measured: Hour 0, 24 hour post-dose
Change of plasma D-dimer
Measured: Hour 0, 48 hour post-dose
Incidence of development of anti-drug antibody (ADA)
Measured: up to 2 months
Incidence of development of neutralizing antibody (NAb)
Measured: up to 2 months
Change of factor X activity
Measured: up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionMar 2016
- Study completionMar 2016
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
- 17 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
- NCT02537002
- Sponsor's protocol ID
- B2341003
- Status last verified
- Apr 2016
- First submitted
- 28 Aug 2015
- Last updated
- 29 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2016. 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, Single Ascending Dose Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of An Intravenous Bolus Infusion Pf-05230907 In Healthy Japanese Subjects
- ClinicalTrials.gov ID
- NCT02537002
- Acronym / sponsor ID
- B2341003
- Conditions
- Healthy
- Keywords
- PF-05230907, Pharmacokinetics, Pharmacodynamic, Immunogenicity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Sep 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 1 Sep 2015 (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 the following:
- To determine the safety and tolerability of single ascending intravenous (IV) doses of PF-05230907 in healthy Japanese subjects.
- To characterize the PK profile of single ascending IV doses of PF-05230907 in healthy Japanese subjects.
- To characterize the PD profiles of single ascending IV doses of PF-05230907 in healthy Japanese subjects.
- To evaluate the immunogenicity of PF-05230907 in healthy Japanese subjects
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1- PF-05230907 or Placebo | Experimental | Drug: PF-05230907, Drug: Placebo |
| Cohort 2- PF-05230907 or Placebo | Experimental | Drug: PF-05230907, Drug: Placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male of females
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs) and <120 kg (265 lbs).
- Japanese subjects who have four biologic Japanese grandparents born in Japan.
Key exclusion criteria (3 listed)
- Pregnant or nursing females.
- Females of childbearing potential who are unwilling or unable to use an acceptable method of contraception.
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease
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-05230907A single intravenous dose of 3 μg/kg | Drug | Cohort 1- PF-05230907 or Placebo |
| PF-05230907A single intravenous dose of 5 μg/kg | Drug | Cohort 2- PF-05230907 or Placebo |
| PlaceboA single intravenous dose of matched placebo | Drug | Cohort 1- PF-05230907 or Placebo, Cohort 2- PF-05230907 or Placebo |
Primary outcome
Incidence of Adverse Events and Serious Adverse Events Per Participant of PF-05230907
Time frame: up to 2 months
13 secondary outcomes
Single dose Time to Reach maximum Observed Plasma Concentration (Tmax) of PF-05230907
Time frame: Minute 0, 2, 5, 15, 40, 60 minute post-dose
Single dose Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]of PF-05230907
Time frame: Minute 0, 2, 5, 15, 40, 60 minute post-dose
Single dose Plasma Decay Half-Life (t1/2) of PF-05230907
Time frame: Minute 0, 2, 5, 15, 40, 60 minute post-dose
Single dose steady state Volume of Distribution (Vss) of PF-05230907
Time frame: Minute 0, 2, 5, 15, 40, 60 minute post-dose
Single dose clearance (CL) of PF-05230907
Time frame: Minute 0, 2, 5, 15, 40, 60 minute post-dose
Single dose Maximum Observed plasma concentration (Cmax) of PF-05230907
Time frame: Minute 0, 2, 5, 15, 40, 60 minute post-dose
Single dose Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (last)]of PF-05230907
Time frame: Minute 0, 2, 5, 15, 40, 60 minute post-dose
Change of aPTT from pre-dose to post-dose
Time frame: Hour 0, 24 hour post-dose
Change of prothrombin fragments 1+2 (PF1+2)
Time frame: Hour 0, 24 hour post-dose
Change of plasma D-dimer
Time frame: Hour 0, 48 hour post-dose
Incidence of development of anti-drug antibody (ADA)
Time frame: up to 2 months
Incidence of development of neutralizing antibody (NAb)
Time frame: up to 2 months
Change of factor X activity
Time frame: up to 2 months
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 29 Apr 2016.
- 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-05230907 in people with Healthy, run by Pfizer at 1 site in United States.
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 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 29 Apr 2016. 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 States. 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?
Incidence of Adverse Events and Serious Adverse Events Per Participant of PF-05230907 (time frame: up to 2 months). 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 29 Apr 2016.