HealthyPhase 1NCT01989143
Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Intravenous and Multiple Subcutaneous and Intravenous Doses of PF-06480605 in Healthy Subjects.
A Phase 1 study testing PF-06480605 in people with Healthy, run by Telavant, Inc. at 1 site in United States.
Trial summary
This single and multiple ascending dose study is a first in human assessment of PF-06480605. The goal is to study the safety, tolerability, pharmacokinetics and pharmacodynamics. 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-06480605
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Mar 2015
- 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 and/or female subjects of non childbearing potential between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests).
- Female subjects of non childbearing potential must meet at least one of the following criteria:
- Achieved postmenopausal status, defined as: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and have a serum follicle stimulating hormone (FSH) level within the laboratory's reference range for postmenopausal females;
- Have undergone a documented hysterectomy and/or bilateral oophorectomy;
- Have medically confirmed ovarian failure. All other female subjects (including females with tubal ligations and females that do NOT have a documented hysterectomy, bilateral oophorectomy and/or ovarian failure) will be considered to be of childbearing potential.
- 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 (or a legal representative) has been informed of all pertinent aspects of the study.
- X-ray with no evidence of current, active TB or previous inactive TB, general infections, heart failure, malignancy, or other clinically significant abnormalities taken at Screening or within 3 months prior to Day 1 and read by a qualified radiologist.
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).
- Subjects with a history of or current positive results for any of the following serological tests: Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (HBcAb), anti Hepatitis C antibody (HCV Ab) or human immunodeficiency virus (HIV).
- Subjects with a history of autoimmune disorders.
- Subjects with a history of allergic or anaphylactic reaction to a therapeutic drug.
- History of tuberculosis or active, latent or inadequately treated tuberculosis infection.
- Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half lives or 180 days for biologics preceding the first dose of study medication.
- Pregnant females; breastfeeding females; and females of childbearing potential.
Trial locations and contacts
1 site in 1 country.
United States1 site
New Haven Clinical Research Unit
New Haven, Connecticut, 06511
About this study
Official title: A Phase 1, Randomzied, Double-blind, Third-party Open Placebo-controlled, Dose Escalating Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Single Intravenous And Multiple Subcutaneous And Intravenous Doses Of Pf-06480605 In Healthy Subjects
This single and multiple ascending dose study is a first in human assessment of PF-06480605. The goal is to study the safety, tolerability, pharmacokinetics and pharmacodynamics.
- Conditions
- Healthy
- Being tested
- PF-06480605, Placebo
- Keywords
- Phase 1, Randomized, Double-blind, Placebo-controlled, Dose escalating, Single and Multiple doses, Safety, Tolerability, PK/PD, PF-06480605
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-06480605Drug
Subjects will receive single intravenous doses of 1, 3, 10, 30, 100, 300, 600 or 800 mg of PF-06480605 solution in a dose escalation format.
PlaceboDrug
Subjects will receive single intravenous doses of PF-06480605 matching placebo solution in a dose escalation format.
PF-06480605Drug
Subjects will receive three subcutaneous doses of 30, 100, or 300 mg of PF-06480605 solution in a dose escalation format of one dose every 2 weeks (q2wk).
PlaceboDrug
Subjects will receive three subcutaneous doses of PF-06480605 matching placebo solution in a dose escalation format of one dose every 2 weeks (q2wk).
PF-06480605Drug
Subjects will receive three intravenous doses of 500 mg of PF-06480605 solution in a dose escalation format of one dose every 2 weeks (q2wk).
PlaceboDrug
Subjects will receive three intravenous doses of PF-06480605 matching placebo solution in a dose escalation format of one dose every 2 weeks (q2wk).
| Study group | Role | What they receive |
|---|---|---|
| SAD Cohorts 1-8 Experimental Arm | Experimental | Not described Receives: Drug: PF-06480605 |
| SAD Cohorts 1-8 Placebo Arm | Placebo comparator | Not described Receives: Drug: Placebo |
| MAD Cohorts 9-11 Experimental Arm | Experimental | Not described Receives: Drug: PF-06480605 |
| MAD Cohorts 9-11 Placebo Arm | Placebo comparator | Not described Receives: Drug: Placebo |
| MAD Cohort 12 Experimental Arm | Experimental | Not described Receives: Drug: PF-06480605 |
| MAD Cohort 12 Placebo Arm | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose limiting or intolerability treatment related adverse events (AEs).
Measured: 6 weeks
Incidence, severity and causal relationship of treatment emergent AEs (TEAEs) and withdrawals due to treatment emergent adverse events.
Measured: 6 weeks
Incidence and magnitude of abnormal laboratory findings.
Measured: 6 weeks
Abnormal and clinically relevant changes in vital signs, blood pressure (BP) and electrocardiogram (ECG) parameters.
Measured: 6 weeks
Secondary outcomes (39)
Single Ascending Dose: Maximum Observed Plasma Concentration (Cmax)
Measured: 6 weeks
Single Ascending Dose: Time to Reach Maximum Observed Plasma Concentration (Tmax)
Measured: 6 weeks
Single Ascending Dose: Area under the plasma concentration-time profile from time zero to 14 days (AUC14 days)
Measured: 6 weeks
Single Ascending Dose: Area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf)
Measured: 6 weeks
Single Ascending Dose: Area under the plasma concentration-time profile from time zero to the time of last quantifiable concentration (AUClast)
Measured: 6 weeks
Single Ascending Dose: Dose normalized maximum plasma concentration (Cmax[dn])
Measured: 6 weeks
Single Ascending Dose: Dose normalized area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf[dn])
Measured: 6 weeks
Single Ascending Dose: Dose normalized area under the plasma concentration-time profile from time zero to the time of last quantifiable concentration (AUClast[dn])
Measured: 6 weeks
Single Ascending Dose: Plasma Decay Half-Life (t1/2)
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Measured: 6 weeks
Single Ascending Dose: Mean residence time(MRT)
Measured: 6 weeks
Single Ascending Dose: Volume of Distribution at Steady State (Vss)
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.
Measured: 6 weeks
Single Ascending Dose: Systemic Clearance (CL)
CL is a quantitative measure of the rate at which a drug substance is removed from the body.
Measured: 6 weeks
Multiple Ascending Dose First Dose: Maximum Observed Plasma Concentration (Cmax)
Measured: 6 weeks
Multiple Ascending Dose First Dose: Time to Reach Maximum Observed Plasma Concentration (Tmax)
Measured: 6 weeks
Multiple Ascending Dose First Dose: Area under the plasma concentration-time profile from time zero to time τ, the dosing interval where τ=2 weeks (AUCτ)
Measured: 6 weeks
Multiple Ascending Dose First Dose: Dose normalized maximum plasma concentration (Cmax[dn])
Measured: 6 weeks
Multiple Ascending Dose First Dose: Dose normalized Area under the plasma concentration-time profile from time zero to time τ, the dosing interval where τ=2 weeks (AUCτ [dn])
Measured: 6 weeks
Plasma Decay Half-Life (t1/2)
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Measured: 6 weeks
Multiple Ascending Dose First Dose: Mean residence time (MRT)
Measured: 6 weeks
Apparent Volume of Distribution (Vz/F)
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
Measured: 6 weeks
Multiple Ascending Dose First Dose: Volume of Distribution at Steady State (Vss)
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.
Measured: 6 weeks
Multiple Ascending Dose First Dose: Apparent Oral Clearance (CL/F)
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Measured: 6 weeks
Multiple Ascending Dose First Dose: Systemic Clearance (CL)
CL is a quantitative measure of the rate at which a drug substance is removed from the body.
Measured: 6 weeks
Multiple Ascending Dose Multiple Dose: Maximum Observed Plasma Concentration (Cmax)
Measured: 6 weeks
Multiple Ascending Dose Multiple Dose: Time to Reach Maximum Observed Plasma Concentration (Tmax)
Measured: 6 weeks
Multiple Ascending Dose Multiple Dose: Area under the plasma concentration-time profile from time zero to time τ, the dosing interval where τ=2 weeks (AUCτ)
Measured: 6 weeks
Multiple Ascending Dose Multiple Dose: Dose normalized maximum plasma concentration (Cmax[dn])
Measured: 6 weeks
Multiple Ascending Dose Multiple Dose: Dose normalized Area under the plasma concentration-time profile from time zero to time τ, the dosing interval where τ=2 weeks (AUCτ [dn])
Measured: 6 weeks
Multiple Ascending Dose Multiple Dose: Plasma Decay Half-Life (t1/2)
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Measured: 6 weeks
Multiple Ascending Dose Multiple Dose: Apparent Volume of Distribution (Vz/F)
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
Measured: 6 weeks
Multiple Ascending Dose Multiple Dose: Volume of Distribution at Steady State (Vss)
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.
Measured: 6 weeks
Multiple Ascending Dose Multiple Dose: Apparent Oral Clearance (CL/F)
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Measured: 6 weeks
Multiple Ascending Dose Multiple Dose: Systemic Clearance (CL)
CL is a quantitative measure of the rate at which a drug substance is removed from the body.
Measured: 6 weeks
Multiple Ascending Dose Multiple Dose: Minimum Observed Plasma Trough Concentration (Cmin)
Measured: 6 weeks
Multiple Ascending Dose Multiple Dose: Average concentration at steady state (Cav)
Measured: 6 weeks
Multiple Ascending Dose Multiple Dose: Observed accumulation ratio (Rac)
Measured: 6 weeks
Multiple Ascending Dose Multiple Dose: Peak to trough fluctuation (PTF)
Measured: 6 weeks
Multiple Ascending Dose Additional Parameter: estimate of bioavailability (F) for subcutaneous administration at the corresponding intravenous dose
Measured: 6 weeks
Immunogenicity for both Single Ascending Dose and Multiple Ascending Dose: Development of anti-drug antibodies (ADA)
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2013 (estimated)
- Study startDec 2013
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Telavant, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01989143
- Sponsor's protocol ID
- B7541001
- Status last verified
- Oct 2023
- First submitted
- 14 Nov 2013
- Last updated
- 19 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Banfield C, Rudin D, Bhattacharya I, Goteti K, Li G, Hassan-Zahraee M, Brown LS, Hung KE, Pawlak S, Lepsy C. First-in-human, randomized dose-escalation study of the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of PF-06480605 in healthy subjects. Br J Clin Pharmacol. 2020 Apr;86(4):812-824. doi: 10.1111/bcp.14187. Epub 2020 Jan 28.
PubMed 31758576
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomzied, Double-blind, Third-party Open Placebo-controlled, Dose Escalating Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Single Intravenous And Multiple Subcutaneous And Intravenous Doses Of Pf-06480605 In Healthy Subjects
- ClinicalTrials.gov ID
- NCT01989143
- Acronym / sponsor ID
- B7541001
- Conditions
- Healthy
- Keywords
- Phase 1, Randomized, Double-blind, Placebo-controlled, Dose escalating, Single and Multiple doses, Safety, Tolerability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Telavant, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Study start
- Dec 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 20 Nov 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.
This single and multiple ascending dose study is a first in human assessment of PF-06480605. The goal is to study the safety, tolerability, pharmacokinetics and pharmacodynamics.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| SAD Cohorts 1-8 Experimental Arm | Experimental | Drug: PF-06480605 |
| SAD Cohorts 1-8 Placebo Arm | Placebo comparator | Drug: Placebo |
| MAD Cohorts 9-11 Experimental Arm | Experimental | Drug: PF-06480605 |
| MAD Cohorts 9-11 Placebo Arm | Placebo comparator | Drug: Placebo |
| MAD Cohort 12 Experimental Arm | Experimental | Drug: PF-06480605 |
| MAD Cohort 12 Placebo Arm | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy male and/or female subjects of non childbearing potential between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests).
- Female subjects of non childbearing potential must meet at least one of the following criteria:
- 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 (or a legal representative) has been informed of all pertinent aspects of the study.
- X-ray with no evidence of current, active TB or previous inactive TB, general infections, heart failure, malignancy, or other clinically significant abnormalities taken at Screening or within 3 months prior to Day 1 and read by a qualified radiologist.
Key exclusion criteria (7 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).
- Subjects with a history of or current positive results for any of the following serological tests: Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (HBcAb), anti Hepatitis C antibody (HCV Ab) or human immunodeficiency virus (HIV).
- Subjects with a history of autoimmune disorders.
- Subjects with a history of allergic or anaphylactic reaction to a therapeutic drug.
- History of tuberculosis or active, latent or inadequately treated tuberculosis infection.
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-06480605Subjects will receive single intravenous doses of 1, 3, 10, 30, 100, 300, 600 or 800 mg of PF-06480605 solution in a dose escalation format. | Drug | SAD Cohorts 1-8 Experimental Arm |
| PlaceboSubjects will receive single intravenous doses of PF-06480605 matching placebo solution in a dose escalation format. | Drug | SAD Cohorts 1-8 Placebo Arm |
| PF-06480605Subjects will receive three subcutaneous doses of 30, 100, or 300 mg of PF-06480605 solution in a dose escalation format of one dose every 2 weeks (q2wk). | Drug | MAD Cohorts 9-11 Experimental Arm |
| PlaceboSubjects will receive three subcutaneous doses of PF-06480605 matching placebo solution in a dose escalation format of one dose every 2 weeks (q2wk). | Drug | MAD Cohorts 9-11 Placebo Arm |
| PF-06480605Subjects will receive three intravenous doses of 500 mg of PF-06480605 solution in a dose escalation format of one dose every 2 weeks (q2wk). | Drug | MAD Cohort 12 Experimental Arm |
| PlaceboSubjects will receive three intravenous doses of PF-06480605 matching placebo solution in a dose escalation format of one dose every 2 weeks (q2wk). | Drug | MAD Cohort 12 Placebo Arm |
Primary outcome
Incidence of dose limiting or intolerability treatment related adverse events (AEs).
Time frame: 6 weeks
Incidence, severity and causal relationship of treatment emergent AEs (TEAEs) and withdrawals due to treatment emergent adverse events.
Time frame: 6 weeks
Incidence and magnitude of abnormal laboratory findings.
Time frame: 6 weeks
Abnormal and clinically relevant changes in vital signs, blood pressure (BP) and electrocardiogram (ECG) parameters.
Time frame: 6 weeks
39 secondary outcomes
Single Ascending Dose: Maximum Observed Plasma Concentration (Cmax)
Time frame: 6 weeks
Single Ascending Dose: Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: 6 weeks
Single Ascending Dose: Area under the plasma concentration-time profile from time zero to 14 days (AUC14 days)
Time frame: 6 weeks
Single Ascending Dose: Area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf)
Time frame: 6 weeks
Single Ascending Dose: Area under the plasma concentration-time profile from time zero to the time of last quantifiable concentration (AUClast)
Time frame: 6 weeks
Single Ascending Dose: Dose normalized maximum plasma concentration (Cmax[dn])
Time frame: 6 weeks
Single Ascending Dose: Dose normalized area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf[dn])
Time frame: 6 weeks
Single Ascending Dose: Dose normalized area under the plasma concentration-time profile from time zero to the time of last quantifiable concentration (AUClast[dn])
Time frame: 6 weeks
Single Ascending Dose: Plasma Decay Half-Life (t1/2)
Time frame: 6 weeks
Single Ascending Dose: Mean residence time(MRT)
Time frame: 6 weeks
Single Ascending Dose: Volume of Distribution at Steady State (Vss)
Time frame: 6 weeks
Single Ascending Dose: Systemic Clearance (CL)
Time frame: 6 weeks
Multiple Ascending Dose First Dose: Maximum Observed Plasma Concentration (Cmax)
Time frame: 6 weeks
Multiple Ascending Dose First Dose: Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: 6 weeks
Multiple Ascending Dose First Dose: Area under the plasma concentration-time profile from time zero to time τ, the dosing interval where τ=2 weeks (AUCτ)
Time frame: 6 weeks
Multiple Ascending Dose First Dose: Dose normalized maximum plasma concentration (Cmax[dn])
Time frame: 6 weeks
Multiple Ascending Dose First Dose: Dose normalized Area under the plasma concentration-time profile from time zero to time τ, the dosing interval where τ=2 weeks (AUCτ [dn])
Time frame: 6 weeks
Plasma Decay Half-Life (t1/2)
Time frame: 6 weeks
Multiple Ascending Dose First Dose: Mean residence time (MRT)
Time frame: 6 weeks
Apparent Volume of Distribution (Vz/F)
Time frame: 6 weeks
Multiple Ascending Dose First Dose: Volume of Distribution at Steady State (Vss)
Time frame: 6 weeks
Multiple Ascending Dose First Dose: Apparent Oral Clearance (CL/F)
Time frame: 6 weeks
Multiple Ascending Dose First Dose: Systemic Clearance (CL)
Time frame: 6 weeks
Multiple Ascending Dose Multiple Dose: Maximum Observed Plasma Concentration (Cmax)
Time frame: 6 weeks
Multiple Ascending Dose Multiple Dose: Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: 6 weeks
Multiple Ascending Dose Multiple Dose: Area under the plasma concentration-time profile from time zero to time τ, the dosing interval where τ=2 weeks (AUCτ)
Time frame: 6 weeks
Multiple Ascending Dose Multiple Dose: Dose normalized maximum plasma concentration (Cmax[dn])
Time frame: 6 weeks
Multiple Ascending Dose Multiple Dose: Dose normalized Area under the plasma concentration-time profile from time zero to time τ, the dosing interval where τ=2 weeks (AUCτ [dn])
Time frame: 6 weeks
Multiple Ascending Dose Multiple Dose: Plasma Decay Half-Life (t1/2)
Time frame: 6 weeks
Multiple Ascending Dose Multiple Dose: Apparent Volume of Distribution (Vz/F)
Time frame: 6 weeks
Multiple Ascending Dose Multiple Dose: Volume of Distribution at Steady State (Vss)
Time frame: 6 weeks
Multiple Ascending Dose Multiple Dose: Apparent Oral Clearance (CL/F)
Time frame: 6 weeks
Multiple Ascending Dose Multiple Dose: Systemic Clearance (CL)
Time frame: 6 weeks
Multiple Ascending Dose Multiple Dose: Minimum Observed Plasma Trough Concentration (Cmin)
Time frame: 6 weeks
Multiple Ascending Dose Multiple Dose: Average concentration at steady state (Cav)
Time frame: 6 weeks
Multiple Ascending Dose Multiple Dose: Observed accumulation ratio (Rac)
Time frame: 6 weeks
Multiple Ascending Dose Multiple Dose: Peak to trough fluctuation (PTF)
Time frame: 6 weeks
Multiple Ascending Dose Additional Parameter: estimate of bioavailability (F) for subcutaneous administration at the corresponding intravenous dose
Time frame: 6 weeks
Immunogenicity for both Single Ascending Dose and Multiple Ascending Dose: Development of anti-drug antibodies (ADA)
Time frame: 6 weeks
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 19 Oct 2023.
- Derived from this study: PubMed 31758576Banfield C, Rudin D, Bhattacharya I, Goteti K, Li G, Hassan-Zahraee M, Brown LS, Hung KE, Pawlak S, Lepsy C. First-in-human, randomized dose-escalation study of the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of PF-06480605 in healthy subjects. Br J Clin Pharmacol. 2020 Apr;86(4):812-824. doi: 10.1111/bcp.14187. Epub 2020 Jan 28.
- 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-06480605 in people with Healthy, run by Telavant, Inc. 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 8 inclusion and 7 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 19 Oct 2023. 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 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 dose limiting or intolerability treatment related adverse events (AEs). (time frame: 6 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01989143, which also lists 1 linked publication.
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 19 Oct 2023.