First in Human Study for PF-06667272

A Phase 1, Randomized, Double-blind (Sponsor-open), Placebo-controlled Study To Assess The Safety, Tolerability, And Pharmacokinetics Of Single Escalating Oral Doses Of Pf-06667272 Under Fed And Fasted Conditions, In Healthy Adult Subjects

The current study is the first clinical trial proposed with PF-06667272. It is designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of single ascending doses of PF-06667272 under fed and fasted conditions, in healthy adult subjects.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: PF-06667272; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy males and female of non-childbearing potential;
• Body Mass Index 17.5-30.5 kg/m2;
• Body weight >50 kg;

Exclusion Criteria:

• Evidence of 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

16

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1_Period 1_Active; Single ascending dose of PF-06667272	Drug: PF-06667272; Single ascending dose of PF-06667272
Placebo Comparator: Cohort 1_Period 1_Placebo; Single dose of placebo	Other: Placebo; Single dose of placebo
Experimental: Cohort 1_Period 2_Active; Single ascending dose of PF-06667272	Drug: PF-06667272; Single ascending dose of PF-06667272
Placebo Comparator: Cohort 1_Period 2_Placebo; Single dose of placebo	Other: Placebo; Single dose of placebo
Experimental: Cohort 1_Period 3_Active; Single ascending dose of PF-06667272	Drug: PF-06667272; Single ascending dose of PF-06667272
Placebo Comparator: Cohort 1_Period 3_Placebo; Single dose of placebo	Other: Placebo; Single dose of placebo
Experimental: Cohrot 1_Period 4_Active; Single ascending dose of PF-06667272	Drug: PF-06667272; Single ascending dose of PF-06667272
Placebo Comparator: Cohort 1_Period 4_Placebo; Single dose of placebo	Other: Placebo; Single dose of placebo
Experimental: Cohort 2_Period 1_Active; Single ascending dose of PF-06667272	Drug: PF-06667272; Single ascending dose of PF-06667272
Placebo Comparator: Cohort 2_Period 1_Placebo; Single dose of placebo	Other: Placebo; Single dose of placebo
Experimental: Cohort 2_Period 2_Active; Single ascending dose of PF-06667272	Drug: PF-06667272; Single ascending dose of PF-06667272
Placebo Comparator: Cohort 2_Period 2_Placebo; Single dose of placebo	Other: Placebo; Single dose of placebo
Experimental: Cohort 2_Period 3_Active; Single ascending dose of PF-06667272	Drug: PF-06667272; Single ascending dose of PF-06667272
Placebo Comparator: Cohort 2_Period 3_Placebo; Single dose of placebo	Other: Placebo; Single dose of placebo
Experimental: Cohort 2_Period 4_Active; Single ascending dose of PF-06667272	Drug: PF-06667272; Single ascending dose of PF-06667272
Placebo Comparator: Cohort 2_Period 4_Placebo; Single dose of placebo	Other: Placebo; Single dose of placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects With Treatment Emergent Treatment-Related Adverse Events (AEs) or other safety concerns	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.	Baseline (Day 1, hour 0) up to 28 days after last dose of study medication

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06667272 and PF-06818073	Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)	0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0- infinity)] for PF-06667272 and PF-06818073 (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).	0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose
Maximum Observed Plasma Concentration (Cmax) for PF-06667272 and PF-06818073	Maximum Observed Plasma Concentration (Cmax)	0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose
Time to Reach Maximum Observed Concentration for PF-06667272 and PF-06818073	Time to Reach Maximum Observed Plasma Concentration (Tmax)	0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose
Plasma Decay Half-Life (t1/2) for PF-06667272 and PF-06818073	Plasma Decay Half-Life (t1/2)	0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose
Apparent Total Body Clearance (CL/F) for PF-06667272	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.	0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose
Apparent Volume of Distribution (Vz/F) for PF-06667272	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, 8, 10, 12, 24, 36, and 48 hours post dose

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2017
• Primary Completion (Actual): September 5, 2017
• Study Completion (Actual): September 5, 2017

Study Registration Dates

• First Submitted: April 19, 2017
• First Submitted That Met QC Criteria: April 19, 2017
• First Posted (Actual): April 24, 2017

Study Record Updates

• Last Update Posted (Actual): October 19, 2017
• Last Update Submitted That Met QC Criteria: October 17, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: C0231002; 2017-000590-36 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes