Normal HealthyPhase 1NCT02871037
Single Dose, Repeated Dose, and Conditional Food Effect Study of PF-05221304 in Healthy Subjects
A Phase 1 study testing PF-05221304 in people with Normal Healthy, run by Pfizer at 1 site in United States.
Trial summary
The current study is the first clinical trial proposed with PF-05221304. It is designed to evaluate the safety, tolerability, and pharmacokinetics (PK) following administration of single and repeated doses of PF-05221304 to healthy adult subjects. The study may also evaluate effect of food on PK of PF-05221304. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Normal Healthy
- What is being tested?
- PF-05221304
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to Mar 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 males and female of non-childbearing potential;
- Body Mass Index 17.5-30.5 kg/m2;
- Body weight >50 kg;
Who cannot join
- Evidence of history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergises, but excluding untreated, asymptomatic, seasonal allergies at time of dosing
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, 3-part Study Of Pf-05221304 In Healthy Adults: Part 1 - Randomized, Double-blind, Placebo-controlled Assessment Of Safety And Pharmacokinetics Of Single, Escalating, Oral Doses; Part 2 - Randomized, Double-blind, Placebo-controlled Assessment Of Safety And Pharmacokinetics Of Repeated, Escalating, Oral Doses; Conditional Part 3 - Effect Of Food On The Pharmacokinetics Of Pf-05221304
The current study is the first clinical trial proposed with PF-05221304. It is designed to evaluate the safety, tolerability, and pharmacokinetics (PK) following administration of single and repeated doses of PF-05221304 to healthy adult subjects. The study may also evaluate effect of food on PK of PF-05221304.
- Conditions
- Normal Healthy
- Being tested
- PF-05221304, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-05221304Drug
Single or repeated, escalating dose of PF-05221304
PlaceboOther
single or repeated dose of placebo
| Study group | Role | What they receive |
|---|---|---|
| Part 1_Cohort 1_Active | Experimental | Single, escalating dose of PF-05221304 Receives: Drug: PF-05221304 |
| Part 1_Cohort 1_Placebo | Placebo comparator | Single dose of Placebo Receives: Other: Placebo |
| Part 1_Cohort 2_Active | Experimental | Single, escalating dose of PF-05221304 Receives: Drug: PF-05221304 |
| Part 1_Cohort 2_Placebo | Experimental | Single dose of Placebo Receives: Other: Placebo |
| Part 2_Active | Experimental | Repeated, escalating doses of PF-05221304 Receives: Drug: PF-05221304 |
| Part 2_Placebo | Placebo comparator | Repeated doses of placebo Receives: Other: Placebo |
| Part 3 | Experimental | Single dose of PF-05221304 with and without food Receives: Drug: PF-05221304 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Number of Subjects experiencing an Adverse Event
Assessment by adverse event monitoring, 12 lead ECGs, telemetry, vital signs and clinical safety laboratory measurements.
Treatment-related AE was any untoward medical occurrence attributed to study drug in a subject who received study drug. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to Drug was assessed by the investigator (Yes/No). Subjects with multiple occurrences of an AE within a category were counted once within the category.
Measured: Screening up to 28 days after last dose of study medication
Part 2: Number of Subjects experiencing an Adverse Event
Assessment by adverse event monitoring, 12 lead ECGs, telemetry, vital signs and clinical safety laboratory measurements.
Treatment-related AE was any untoward medical occurrence attributed to study drug in a subject who received study drug. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to Drug was assessed by the investigator (Yes/No). Subjects with multiple occurrences of an AE within a category were counted once within the category.
Measured: Screening up to 28 days after last dose of study medication
Part 3: Maximum Observed Plasma Concentration (Cmax) for PF-05221304
Maximum Observed Plasma Concentration (Cmax)
Measured: 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, and 48 hours post dose
Part 3: Time to Reach Maximum Observed Concentration for PF-05221304
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Measured: 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, and 48 hours post dose
Part 3: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-05221304
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Measured: 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, and 48 hours post dose
Part 3: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0- infinity)] for PF-05221304 (as permitted)
AUC (0-infinity)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-infinity). It is obtained from AUC (0-t) plus AUC (t-infinity).
Measured: 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, and 48 hours post dose
Part 3: Plasma Decay Half-Life (t1/2) for PF-05221304 (as permitted)
Plasma Decay Half-Life (t1/2)
Measured: 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, and 48 hours post dose
Part 3: Apparent Total Body Clearance (CL/F) for PF-05221304 (as permitted)
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 apparent total body 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: 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, and 48 hours post dose
Part 3: Apparent Volume of Distribution (Vz/F) for PF-05221304 (as permitted)
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: 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, and 48 hours post dose
Secondary outcomes (22)
Part 1:Maximum Observed Plasma Concentration (Cmax) for PF-05221304
Maximum Observed Plasma Concentration (Cmax)
Measured: 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, and 48 hours post dose
Part 1: Time to Reach Maximum Observed Concentration for PF-05221304
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Measured: 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, and 48 hours post dose
Part 1: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-05221304
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Measured: 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, and 48 hours post dose
Part 1: dose-normalized Cmax and AUClast for PF05221304
Measured: 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, and 48 hours post dose
Part 1: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0- infinity)] for PF-05221304 (as permitted)
AUC (0-infinity)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-infinity). It is obtained from AUC (0-t) plus AUC (t-infinity).
Measured: 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, and 48 hours post dose
Part 1: Plasma Decay Half-Life (t1/2) for PF-05221304 (as permitted)
Plasma Decay Half-Life (t1/2)
Measured: 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, and 48 hours post dose
Part 1: Apparent Total Body Clearance (CL/F) for PF-05221304 (as permitted)
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 apparent total body 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: 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, and 48 hours post dose
Part 1: Apparent Volume of Distribution (Vz/F) for PF-05221304 (as permitted)
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: 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, and 48 hours post dose
Part 2: Single dose plasma parameters of Cmax for PF-05221304
Maximum Observed Plasma Concentration (Cmax)
Measured: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post dose on Day 1
Part 2: Single-dose plasma parameters of Tmax for PF-05221304
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Measured: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post dose on Day 1
Part 2: Single-dose plasma parameters of Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for PF-05221304
Area under the concentration curve from time 0 to end of dosing interval (AUCtau)
Measured: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post dose on Day 1
Part 2: Multiple-dose plasma parameters of Cmax for PF-05221304
Maximum Observed Plasma Concentration (Cmax)
Measured: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post dose for Day 7; (and Day 14, as permitted)
Part 2: Multiple-dose plasma parameters of Tmax for PF-05221304
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Measured: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post dose for Day 7; (and Day 14, as permitted)
Part 2: Multiple-dose plasma parameters of AUCtau for PF-05221304
Area under the concentration curve from time 0 to end of dosing interval (AUCtau)
Measured: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post dose for Day 7; (and Day 14, as permitted)
Part 2: Multiple-dose plasma parameters of Minimum Observed Plasma Trough Concentration (Cmin) for PF-05221304
Measured: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post dose for Day 7; (and Day 14, as permitted)
Part 2: Multiple-dose plasma parameters of CL/F for PF-05221304
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 apparent total body 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: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post dose for Day 7; (and Day 14, as permitted)
Part 2: Multiple-dose plasma parameters of Vz/F for PF-05221304 (as permitted)
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: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 16 hours on Day 1 and 7, and 0 hr on Day 2, Day 4, Day 8, Day 10, Day 13, Day 15, and Day 16 post dose
Part 2: Multiple-dose plasma parameters of Peak-trough ratio (PTR) for PF-05221304
Measured: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post dose for Day 7; (and Day 14, as permitted)
Part 2: Multiple-dose plasma parameters of Observed accumulation ratio for Cmax (Rac(Cmax)) for PF-05221304
Measured: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post dose for Day 7; (and Day 14, as permitted)
Part 2: Multiple-dose plasma parameters of Observed accumulation ratio (Rac(AUCtau))
Measured: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post dose for Day 7; (and Day 14, as permitted)
Part 2: Multiple-dose plasma parameters of Plasma Decay Half-Life (t1/2) for PF-05221304 (as permitted)
Plasma Decay Half-Life (t1/2)
Measured: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 16 hours on Day 1 and 7, and 0 hr on Day 2, Day 4, Day 8, Day 10, Day 13, Day 15, and Day 16 post dose
Part 3: Number of Subjects experiencing an Adverse Event
Assessment by adverse event monitoring, 12 lead ECGs, telemetry, vital signs and clinical safety laboratory measurements.
Treatment-related AE was any untoward medical occurrence attributed to study drug in a subject who received study drug. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to Drug was assessed by the investigator (Yes/No). Subjects with multiple occurrences of an AE within a category were counted once within the category.
Measured: Screening up to 28 days after last dose of study medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 96 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
- NCT02871037
- Sponsor's protocol ID
- C1171001
- Status last verified
- May 2018
- First submitted
- 10 Aug 2016
- Last updated
- 24 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, 3-part Study Of Pf-05221304 In Healthy Adults: Part 1 - Randomized, Double-blind, Placebo-controlled Assessment Of Safety And Pharmacokinetics Of Single, Escalating, Oral Doses; Part 2 - Randomized, Double-blind, Placebo-controlled Assessment Of Safety And Pharmacokinetics Of Repeated, Escalating, Oral Doses; Conditional Part 3 - Effect Of Food On The Pharmacokinetics Of Pf-05221304
- ClinicalTrials.gov ID
- NCT02871037
- Acronym / sponsor ID
- C1171001
- Conditions
- Normal Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Aug 2016 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 18 Aug 2016 (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 current study is the first clinical trial proposed with PF-05221304. It is designed to evaluate the safety, tolerability, and pharmacokinetics (PK) following administration of single and repeated doses of PF-05221304 to healthy adult subjects. The study may also evaluate effect of food on PK of PF-05221304.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Part 1_Cohort 1_Active | Experimental | Drug: PF-05221304Single, escalating dose of PF-05221304 |
| Part 1_Cohort 1_Placebo | Placebo comparator | Other: PlaceboSingle dose of Placebo |
| Part 1_Cohort 2_Active | Experimental | Drug: PF-05221304Single, escalating dose of PF-05221304 |
| Part 1_Cohort 2_Placebo | Experimental | Other: PlaceboSingle dose of Placebo |
| Part 2_Active | Experimental | Drug: PF-05221304Repeated, escalating doses of PF-05221304 |
| Part 2_Placebo | Placebo comparator | Other: PlaceboRepeated doses of placebo |
| Part 3 | Experimental | Drug: PF-05221304Single dose of PF-05221304 with and without food |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy males and female of non-childbearing potential;
- Body Mass Index 17.5-30.5 kg/m2;
- Body weight >50 kg;
Key exclusion criteria (1 listed)
- Evidence of history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergises, but excluding untreated, asymptomatic, seasonal allergies at time of dosing
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-05221304Single or repeated, escalating dose of PF-05221304 | Drug | Part 1_Cohort 1_Active, Part 1_Cohort 2_Active, Part 2_Active, Part 3 |
| Placebosingle or repeated dose of placebo | Other | Part 1_Cohort 1_Placebo, Part 1_Cohort 2_Placebo, Part 2_Placebo |
Primary outcome
Part 1: Number of Subjects experiencing an Adverse Event
Time frame: Screening up to 28 days after last dose of study medication
Assessment by adverse event monitoring, 12 lead ECGs, telemetry, vital signs and clinical safety laboratory measurements. Treatment-related AE was any untoward medical occurrence attributed to study drug in a subject who received study drug. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to Drug was assessed by the investigator (Yes/No). Subjects with multiple occurrences of an AE within a category were counted once within the category.
Part 2: Number of Subjects experiencing an Adverse Event
Time frame: Screening up to 28 days after last dose of study medication
Assessment by adverse event monitoring, 12 lead ECGs, telemetry, vital signs and clinical safety laboratory measurements. Treatment-related AE was any untoward medical occurrence attributed to study drug in a subject who received study drug. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to Drug was assessed by the investigator (Yes/No). Subjects with multiple occurrences of an AE within a category were counted once within the category.
Part 3: Maximum Observed Plasma Concentration (Cmax) for PF-05221304
Time frame: 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, and 48 hours post dose
Maximum Observed Plasma Concentration (Cmax)
Part 3: Time to Reach Maximum Observed Concentration for PF-05221304
Time frame: 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, and 48 hours post dose
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Part 3: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-05221304
Time frame: 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, and 48 hours post dose
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Part 3: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0- infinity)] for PF-05221304 (as permitted)
Time frame: 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, and 48 hours post dose
AUC (0-infinity)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-infinity). It is obtained from AUC (0-t) plus AUC (t-infinity).
Part 3: Plasma Decay Half-Life (t1/2) for PF-05221304 (as permitted)
Time frame: 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, and 48 hours post dose
Plasma Decay Half-Life (t1/2)
Part 3: Apparent Total Body Clearance (CL/F) for PF-05221304 (as permitted)
Time frame: 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, and 48 hours post dose
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 apparent total body 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.
Part 3: Apparent Volume of Distribution (Vz/F) for PF-05221304 (as permitted)
Time frame: 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, and 48 hours post dose
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.
22 secondary outcomes
Part 1:Maximum Observed Plasma Concentration (Cmax) for PF-05221304
Time frame: 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, and 48 hours post dose
Part 1: Time to Reach Maximum Observed Concentration for PF-05221304
Time frame: 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, and 48 hours post dose
Part 1: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-05221304
Time frame: 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, and 48 hours post dose
Part 1: dose-normalized Cmax and AUClast for PF05221304
Time frame: 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, and 48 hours post dose
Part 1: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0- infinity)] for PF-05221304 (as permitted)
Time frame: 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, and 48 hours post dose
Part 1: Plasma Decay Half-Life (t1/2) for PF-05221304 (as permitted)
Time frame: 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, and 48 hours post dose
Part 1: Apparent Total Body Clearance (CL/F) for PF-05221304 (as permitted)
Time frame: 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, and 48 hours post dose
Part 1: Apparent Volume of Distribution (Vz/F) for PF-05221304 (as permitted)
Time frame: 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, and 48 hours post dose
Part 2: Single dose plasma parameters of Cmax for PF-05221304
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post dose on Day 1
Part 2: Single-dose plasma parameters of Tmax for PF-05221304
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post dose on Day 1
Part 2: Single-dose plasma parameters of Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for PF-05221304
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post dose on Day 1
Part 2: Multiple-dose plasma parameters of Cmax for PF-05221304
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post dose for Day 7; (and Day 14, as permitted)
Part 2: Multiple-dose plasma parameters of Tmax for PF-05221304
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post dose for Day 7; (and Day 14, as permitted)
Part 2: Multiple-dose plasma parameters of AUCtau for PF-05221304
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post dose for Day 7; (and Day 14, as permitted)
Part 2: Multiple-dose plasma parameters of Minimum Observed Plasma Trough Concentration (Cmin) for PF-05221304
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post dose for Day 7; (and Day 14, as permitted)
Part 2: Multiple-dose plasma parameters of CL/F for PF-05221304
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post dose for Day 7; (and Day 14, as permitted)
Part 2: Multiple-dose plasma parameters of Vz/F for PF-05221304 (as permitted)
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 16 hours on Day 1 and 7, and 0 hr on Day 2, Day 4, Day 8, Day 10, Day 13, Day 15, and Day 16 post dose
Part 2: Multiple-dose plasma parameters of Peak-trough ratio (PTR) for PF-05221304
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post dose for Day 7; (and Day 14, as permitted)
Part 2: Multiple-dose plasma parameters of Observed accumulation ratio for Cmax (Rac(Cmax)) for PF-05221304
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post dose for Day 7; (and Day 14, as permitted)
Part 2: Multiple-dose plasma parameters of Observed accumulation ratio (Rac(AUCtau))
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post dose for Day 7; (and Day 14, as permitted)
Part 2: Multiple-dose plasma parameters of Plasma Decay Half-Life (t1/2) for PF-05221304 (as permitted)
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 16 hours on Day 1 and 7, and 0 hr on Day 2, Day 4, Day 8, Day 10, Day 13, Day 15, and Day 16 post dose
Part 3: Number of Subjects experiencing an Adverse Event
Time frame: Screening up to 28 days after last dose of study medication
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 24 May 2018.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- 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-05221304 in people with Normal 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 1 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 24 May 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 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?
Part 1: Number of Subjects experiencing an Adverse Event (time frame: Screening up to 28 days after last dose of study medication). The study lists 9 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 24 May 2018.