Single Dose, Repeated Dose, and Conditional Food Effect Study of PF-05221304 in Healthy Subjects

NCT02871037 | Completed Phase 1

• 1 other identifier: C1171001
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Normal Healthy

Outcome Measures

Primary Outcomes (9)

• 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.

  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.

  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)

  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)

  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)

  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).

  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)

  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.

  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.

  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

  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

  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

  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

  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)

  0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, and 48 hours post dose

Study Arms (7)

Part 1_Cohort 1_Active

EXPERIMENTAL

Single, escalating dose of PF-05221304

Drug: PF-05221304

Part 1_Cohort 1_Placebo

PLACEBO COMPARATOR

Single dose of Placebo

Other: Placebo

Part 1_Cohort 2_Active

EXPERIMENTAL

Single, escalating dose of PF-05221304

Drug: PF-05221304

Part 1_Cohort 2_Placebo

EXPERIMENTAL

Single dose of Placebo

Other: Placebo

Part 2_Active

EXPERIMENTAL

Repeated, escalating doses of PF-05221304

Drug: PF-05221304

Part 2_Placebo

PLACEBO COMPARATOR

Repeated doses of placebo

Other: Placebo

Part 3

EXPERIMENTAL

Single dose of PF-05221304 with and without food

Drug: PF-05221304

Interventions

PF-05221304 DRUG

Single or repeated, escalating dose of PF-05221304

Part 1_Cohort 1_Active; Part 1_Cohort 2_Active; Part 2_Active; Part 3

Placebo OTHER

single or repeated dose of placebo

Part 1_Cohort 1_Placebo; Part 1_Cohort 2_Placebo; Part 2_Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

New Haven Clinical Research Unit

New Haven, Connecticut, 06511, United States

Location

Related Links

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

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2016
• First Posted: August 18, 2016
• Study Start: August 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: May 24, 2018

Record last verified: 2018-05

Locations

US (1)