HealthyPhase 1NCT03020784
Safety and Tolerability of PF-06818883 in Healthy Subjects
A Phase 1 study testing PF-06818883 in people with Healthy, run by Pfizer at 1 site in United States.
Trial summary
Safety, Tolerability and Pharmacokinetics of PF-06818883 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-06818883
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Nov 2016to 13 Jun 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 female subjects of nonchildbearing potential and/or male subjects
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
- Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study
- Subjects who are willing and able to comply with all 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
- Any condition possibly affecting the placement of an intravenous drug administration line.
- A confirmed positive urine drug screen
- History of regular alcohol consumption exceeding 7 drinks/week for females or 14 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
- Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day or 2 chews of tobacco per day
- Treatment with an investigational drug within 30 days (or as determined by the local requirement)
Show all 12Show fewer
- Screening supine blood pressure >140 mm Hg (systolic) or <90 mm Hg (diastolic), following at least 5 minutes of supine rest
- Screening supine 12-lead ECG demonstrating QTc >450 msec or a QRS interval >120 msec.
- Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing.
- History of sensitivity to heparin or heparin-induced thrombocytopenia
- History of human immunodeficiency virus (HIV), hepatitis B or C; positive testing for HIV, hepatitis B surface antigen (HepBsAg), hepatitis B core antibody (HepBcAb) or hepatitis C antibody (HCVAb).
- Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product
Trial locations and contacts
1 site in 1 country.
United States1 site
Pfizer New Haven Clinical Research Unit
New Haven, Connecticut, 06511
About this study
Official title: A Phase 1, Randomized, Double-blind, Sponsor-open, Placebo-controlled, Single-ascending Dose Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of Pf-06818883 Following Single Intravenous Administration In Healthy Subjects
Safety, Tolerability and Pharmacokinetics of PF-06818883
- Conditions
- Healthy
- Being tested
- Placebo, PF-06818883
- Keywords
- acute neuroinflammatory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo
PF-06818883Drug
Treatment
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | IV placebo Receives: Drug: Placebo |
| PF-06818883 | Experimental | Experimental drug Receives: Drug: PF-06818883 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Number of Participants with Adverse Events as a Measure of Safety and Tolerability
An assessment of Adverse Events
Measured: Day 0, Day 1, Day 2, Day 3
Change in Physical examination
Safety test to check overall health
Measured: Day 0, Day 1, Day 2 and Day 3
Change in Neurological Exam
Assessment of sensory neuron and motor responses
Measured: Day 0, Day 1, Day 2 and Day 3
Change in 12-lead ECG (electrocardiogram)
heart's electrical activity recorded from electrodes on the body surface
Measured: Day 1 hr 0.25, 1, 2, 6, 8, 12, Day 2 hr 24 and 36, Day 3 hr 48
Change in Vital signs
clinical measurements, specifically pulse rate, temperature, and blood pressure, that indicate the state of a patient's essential body functions
Measured: Day 1 hr 0.25, 1, 2, 6, 8, 12, Day 2 hr 24 and 36, Day 3 hr 48
Change in Clinical laboratory tests (haematology: haemoglobin; haematocrit/erythrocytes; haemoglobin/erythroctes; Erythro-, leuco-,lympho-, mono-Cytes; Platelets)
Intended to detect, identify, or quantify one or more significant substances, evaluate organ functions, or establish the nature of a condition
Measured: Day 0, Day 2 and Day 3
Secondary outcomes (10)
Maximum Observed Plasma Concentration (Cmax) after single dose for all periods
Cmax after a single dose
Measured: Day 1 hr 0.25, 0.5, 1, 1.5, 2, 3, 6, 8, 12, 16, Day 2 hr 24 and 36, Day 3 hr 48
Time to Reach Maximum Observed Plasma Concentration (Tmax) after single dose for all periods
Tmax after single dose
Measured: Day 1 hr 0.25, 0.5, 1, 1.5, 2, 3, 6, 8, 12, 16, Day 2 hr 24 and 36, Day 3 hr 48
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) after single dose for all periods
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) after single dose
Measured: Day 1 hr 0.25, 0.5, 1, 1.5, 2, 3, 6, 8, 12, 16, Day 2 hr 24 and 36, Day 3 hr 48
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - inf)] after single dose for all periods
AUC (0 - inf)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf). It is obtained from AUC (0 - t) plus AUC (t - inf) after single dose
Measured: Day 1 hr 0.25, 0.5, 1, 1.5, 2, 3, 6, 8, 12, 16, Day 2 hr 24 and 36, Day 3 hr 48
Plasma Decay Half-Life (t1/2) after single dose for all periods
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half after single dose
Measured: Day 1 hr 0.25, 0.5, 1, 1.5, 2, 3, 6, 8, 12, 16, Day 2 hr 24 and 36, Day 3 hr 48
Clearance (CL) after single dose for all periods
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.
Measured: Day 1 hr 0.25, 0.5, 1, 1.5, 2, 3, 6, 8, 12, 16, Day 2 hr 24 and 36, Day 3 hr 48
Volume of Distribution (Vss) after single dose for all periods
Volume of distribution is defined as the volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.
Measured: Day 1 hr 0.25, 0.5, 1, 1.5, 2, 3, 6, 8, 12, 16, Day 2 hr 24 and 36, Day 3 hr 48
Dose-Normalized Maximum Plasma Concentration (Cmax(dn)) after single dose for all period
Dose-Normalized Cmax after a single dose
Measured: Day 1 hr, 0.25, 0.5, 1, 1.5, 2, 3, 6, 8, 12, 16, Day 2 hr 24 and 36, Day 3 hr 48
Dose Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast(dn)) after single dose for all periods
Dose Normalized Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast(dn)) after single dose
Measured: Day 1 hr 0.25, 0.5, 1, 1.5, 2, 3, 6, 8, 12, 16, Day 2 hr 24 and 36, Day 3 hr 48
Dose Normalized Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - inf(dn))] after single dose for all periods
AUC (0 - inf (dn)) = Dose Normalized Area under the plasma concentration versus time curve (AUC(dn)) from time zero (pre-dose) to extrapolated infinite time (0 - inf). It is obtained from AUC (0 - t) plus AUC (t - inf) after single dose
Measured: Day 1 hr 0.25, 0.5, 1, 1.5, 2, 3, 6, 8, 12, 16, Day 2 hr 24 and 36, Day 3 hr 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2017 (estimated)
- Study start11 Nov 2016
- Primary completion13 Jun 2017
- Study completion13 Jun 2017
Why it stopped: The study was terminated on 16JUN2017 for safety reasons
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
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 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
- NCT03020784
- Sponsor's protocol ID
- C0601001
- Status last verified
- Dec 2017
- First submitted
- 27 Oct 2016
- Last updated
- 11 Dec 2017
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 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, Single-ascending Dose Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of Pf-06818883 Following Single Intravenous Administration In Healthy Subjects
- ClinicalTrials.gov ID
- NCT03020784
- Acronym / sponsor ID
- C0601001
- Conditions
- Healthy
- Keywords
- acute neuroinflammatory
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated on 16JUN2017 for safety reasons
- Enrolment
- 30 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 11 Nov 2016 (actual)
- Primary completion
- 13 Jun 2017 (actual)
- Study completion
- 13 Jun 2017 (actual)
- First posted
- 13 Jan 2017 (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.
Safety, Tolerability and Pharmacokinetics of PF-06818883
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboIV placebo |
| PF-06818883 | Experimental | Drug: PF-06818883Experimental drug |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy female subjects of nonchildbearing potential and/or male subjects
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
- Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study
- Subjects who are willing and able to comply with all 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
- Any condition possibly affecting the placement of an intravenous drug administration line.
- A confirmed positive urine drug screen
- History of regular alcohol consumption exceeding 7 drinks/week for females or 14 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
- Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day or 2 chews of tobacco per day
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 |
|---|---|---|
| PlaceboPlacebo | Drug | Placebo |
| PF-06818883Treatment | Drug | PF-06818883 |
Primary outcome
Change in Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: Day 0, Day 1, Day 2, Day 3
An assessment of Adverse Events
Change in Physical examination
Time frame: Day 0, Day 1, Day 2 and Day 3
Safety test to check overall health
Change in Neurological Exam
Time frame: Day 0, Day 1, Day 2 and Day 3
Assessment of sensory neuron and motor responses
Change in 12-lead ECG (electrocardiogram)
Time frame: Day 1 hr 0.25, 1, 2, 6, 8, 12, Day 2 hr 24 and 36, Day 3 hr 48
heart's electrical activity recorded from electrodes on the body surface
Change in Vital signs
Time frame: Day 1 hr 0.25, 1, 2, 6, 8, 12, Day 2 hr 24 and 36, Day 3 hr 48
clinical measurements, specifically pulse rate, temperature, and blood pressure, that indicate the state of a patient's essential body functions
Change in Clinical laboratory tests (haematology: haemoglobin; haematocrit/erythrocytes; haemoglobin/erythroctes; Erythro-, leuco-,lympho-, mono-Cytes; Platelets)
Time frame: Day 0, Day 2 and Day 3
Intended to detect, identify, or quantify one or more significant substances, evaluate organ functions, or establish the nature of a condition
10 secondary outcomes
Maximum Observed Plasma Concentration (Cmax) after single dose for all periods
Time frame: Day 1 hr 0.25, 0.5, 1, 1.5, 2, 3, 6, 8, 12, 16, Day 2 hr 24 and 36, Day 3 hr 48
Time to Reach Maximum Observed Plasma Concentration (Tmax) after single dose for all periods
Time frame: Day 1 hr 0.25, 0.5, 1, 1.5, 2, 3, 6, 8, 12, 16, Day 2 hr 24 and 36, Day 3 hr 48
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) after single dose for all periods
Time frame: Day 1 hr 0.25, 0.5, 1, 1.5, 2, 3, 6, 8, 12, 16, Day 2 hr 24 and 36, Day 3 hr 48
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - inf)] after single dose for all periods
Time frame: Day 1 hr 0.25, 0.5, 1, 1.5, 2, 3, 6, 8, 12, 16, Day 2 hr 24 and 36, Day 3 hr 48
Plasma Decay Half-Life (t1/2) after single dose for all periods
Time frame: Day 1 hr 0.25, 0.5, 1, 1.5, 2, 3, 6, 8, 12, 16, Day 2 hr 24 and 36, Day 3 hr 48
Clearance (CL) after single dose for all periods
Time frame: Day 1 hr 0.25, 0.5, 1, 1.5, 2, 3, 6, 8, 12, 16, Day 2 hr 24 and 36, Day 3 hr 48
Volume of Distribution (Vss) after single dose for all periods
Time frame: Day 1 hr 0.25, 0.5, 1, 1.5, 2, 3, 6, 8, 12, 16, Day 2 hr 24 and 36, Day 3 hr 48
Dose-Normalized Maximum Plasma Concentration (Cmax(dn)) after single dose for all period
Time frame: Day 1 hr, 0.25, 0.5, 1, 1.5, 2, 3, 6, 8, 12, 16, Day 2 hr 24 and 36, Day 3 hr 48
Dose Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast(dn)) after single dose for all periods
Time frame: Day 1 hr 0.25, 0.5, 1, 1.5, 2, 3, 6, 8, 12, 16, Day 2 hr 24 and 36, Day 3 hr 48
Dose Normalized Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - inf(dn))] after single dose for all periods
Time frame: Day 1 hr 0.25, 0.5, 1, 1.5, 2, 3, 6, 8, 12, 16, Day 2 hr 24 and 36, Day 3 hr 48
Results and safety
The study was stopped early (reason given: The study was terminated on 16JUN2017 for safety reasons). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2017.
- 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-06818883 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 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: stopped early, as of the sponsor's last update on 11 Dec 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 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. 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 was stopped early (reason given: The study was terminated on 16JUN2017 for safety reasons). Results are not available in the source record.
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?
Change in Number of Participants with Adverse Events as a Measure of Safety and Tolerability (time frame: Day 0, Day 1, Day 2, Day 3). 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 11 Dec 2017.