Single Dose Study of PF-06815345 in Healthy Subjects

September 26, 2018 updated by: Pfizer

A Phase 1, Randomized, Double-blind, Placebo-controlled Study To Assess Safety, Tolerability, And Pharmacokinetics Of Single Escalating Oral Doses Of Pf-06815345, As Well As Characterize The Pharmacokinetics Of Two Formulations And Effect Of Food On Pharmacokinetics Of One Formulation Of Pf-06815345 Administered To Healthy Adult Subjects

The current study is the first clinical trial proposed with PF-06815345. It is designed to evaluate the safety, tolerability, and pharmacokinetics (PK) following administration of single oral doses of PF-06815345 to healthy adult subjects.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1070
        • Pfizer Clinical Research Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy males and female of non-childbearing potential;
  • Age of 18-55, inclusive;
  • Body Mass Index 17.5-34.9 kg/m2, inclusive;
  • Body weight >50 kg;
  • Not on any prescription or non-prescription drugs within 7 days or 5 half-lives prior to first dose.

Exclusion Criteria:

- 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Part 1_Cohort 1_Active;
Single ascending dose of PF-06815345
Drug: PF-06815345
PF-06815345 will be administered as a liquid dosage formulation
Drug: PF-06815345
PF-06815345 will be administered as either solid dosage formulation or liquid dosage formulation
Placebo Comparator: Part 1_Cohort 1_Placebo;
Single dose of placebo
Other: Placebo
Placebo
Experimental: Part 1_Cohort 2_Active
Single ascending dose of PF-06815345
Drug: PF-06815345
PF-06815345 will be administered as a liquid dosage formulation
Drug: PF-06815345
PF-06815345 will be administered as either solid dosage formulation or liquid dosage formulation
Placebo Comparator: Part 1_Cohort 2_Placebo
Single dose of placebo
Other: Placebo
Placebo
Experimental: Part 2
Single dose of solid dosage formulation (test) versus liquid dosage formulation (reference) of PF-06815345
Drug: PF-06815345
PF-06815345 will be administered as a liquid dosage formulation
Drug: PF-06815345
PF-06815345 will be administered as either solid dosage formulation or liquid dosage formulation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Subjects With Treatment Emergent Treatment-Related Adverse Events (AEs)
Time Frame: Baseline (Day 0) up to 28 days after last dose of study medication
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.
Baseline (Day 0) up to 28 days after last dose of study medication

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06815345
Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0- infinity)] for PF-06815345
Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, 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).
0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose
Maximum Observed Plasma Concentration (Cmax) for PF-06815345
Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose
Maximum Observed Plasma Concentration (Cmax)
0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose
Time to Reach Maximum Observed Concentration for PF-06815345
Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose
Time to Reach Maximum Observed Plasma Concentration (Tmax)
0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose
Plasma Decay Half-Life (t1/2) for PF-06815345
Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose
Plasma Decay Half-Life (t1/2)
0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose
Apparent Oral Clearance (CL/F) for PF-06815345
Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, 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 oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose
Apparent Volume of Distribution (Vz/F) for PF-06815345
Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, 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.
0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for the metabolite (PF-06811701)
Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0- infinity)] for metabolite (PF-06811701)
Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, 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).
0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose
Maximum Observed Plasma Concentration (Cmax) for metabolite (PF-06811701)
Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose
Maximum Observed Plasma Concentration (Cmax)
0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose
Time to Reach Maximum Observed Concentration for metabolite (PF-06811701)
Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose
Time to Reach Maximum Observed Plasma Concentration (Tmax)
0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose
Plasma Decay Half-Life (t1/2) for metabolite (PF-06811701)
Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose
Plasma Decay Half-Life (t1/2)
0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 17, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 11, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 13, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 28, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 26, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • C0281001
  • 2015-003935-36 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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