A Study To Evaluate Different Formulations Of PF-06865571 In Healthy Subjects

NCT03372044 | Completed Phase 1 FDA Drug

• 2 other identifiers: C25410032017-003797-14
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

An open-label study to understand the effect of different modified release and immediate release formulations on plasma PF-06865571 concentrations after single oral administration under fed conditions

Conditions

Healthy

Keywords

Relative bioavailability; Modified release; Pharmacokinetics

Outcome Measures

Primary Outcomes (5)

• Maximum Observed Plasma Concentration (Cmax) for PF-06865571

  0,0.5,1,2,3,4,6,8,12,24,36,48 hours post dose in each period

• Time to Reach Maximum Observed Concentration for PF-06865571

  Time to Reach Maximum Observed Plasma Concentration (Tmax)

  0,0.5,1,2,3,4,6,8,12,24,36,48 hours post dose in each period

• Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06865571

  Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)

  0,0.5,1,2,3,4,6,8,12,24,36,48 hours post dose in each period

• Area Under the Curve From Time Zero to Extrapolated Infinite Time for PF-06865571

  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).

  0,0.5,1,2,3,4,6,8,12,24,36,48 hours post dose in each period

• Plasma Decay Half-Life (t1/2) for PF-06865571

  Plasma Decay Half-Life (t1/2)

  0,0.5,1,2,3,4,6,8,12,24,36,48 hours post dose in each period

Secondary Outcomes (4)

• Number of subjects with adverse events (AEs)

  Baseline up to 35 days after last dose

• Number of subjects with laboratory tests findings of potential clinical importance

  Baseline (Day 0) up to 48 hours after last dose of study medication

• Number of subjects with electrocardiogram (ECG) findings of potential clinical importance

  Baseline (Day 0) up to 48 hours after last dose of study medication

• Number of subjects with vital signs findings of potential clinical importance

  Baseline (Day 0) up to 48 hours after last dose of study medication

Study Arms (1)

PF-06865571

EXPERIMENTAL

Treatment

Drug: PF-06865571 Immediate release suspension; Drug: PF-06865571 Slow release MR tablets; Drug: PF-06865571 Fast release MR tablets; Drug: PF-06865571 Immediate release tablets

Interventions

PF-06865571 Immediate release suspension DRUG

Suspension

PF-06865571

PF-06865571 Slow release MR tablets DRUG

Modified release tablets

PF-06865571

PF-06865571 Fast release MR tablets DRUG

Modified release tablets

PF-06865571

PF-06865571 Immediate release tablets DRUG

Immediate release tablets

PF-06865571

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
• Age of 18-55, inclusive
• Body Mass Index 17.5 to 30.5 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.

You may not qualify if:

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
• Any condition possibly affecting drug absorption (eg, gastrectomy).
• A positive urine drug test.
• History of regular alcohol consumption exceeding 14 drinks/week for female subjects or 21 drinks/week for male subjects (1 drink = 5 ounces \[150 mL\] of wine or 12 ounces \[360 mL\] of beer or 1.5 ounces \[45 mL\] of hard liquor) within 6 months before screening.
• Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half lives preceding the first dose of investigational product (whichever is longer).
• Screening supine BP \>=140 mm Hg (systolic) or \>= 90 mm Hg (diastolic), following at least 5 minutes of supine rest.
• Screening supine 12 lead ECG demonstrating a corrected QT (QTc) interval \>450 msec or a QRS interval \>120 msec.
• Subjects with ANY of the following abnormalities in clinical laboratory tests at screening, as assessed by the study specific laboratory and confirmed by a single repeat test, if deemed necessary:
• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level \>=1.25 × upper limit of normal (ULN);
• Total bilirubin level \>=1.5 × ULN; subjects with a history of Gilbert's syndrome may have direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is =\<ULN.
• Fertile male subjects who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product.
• Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing.
• History of sensitivity to heparin or heparin induced thrombocytopenia only if heparin is used to flush any intravenous catheters in the study.
• History of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HepBsAg), hepatitis B core antibody (HepBcAb), or hepatitis C antibody (HCVAb).
• Unwilling or unable to comply with Lifestyle Requirements in the protocol

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Clinical Research Unit

Brussels, B-1070, Belgium

Location

Related Links

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

MeSH Terms

Interventions

ervogastat

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2017
• First Posted: December 13, 2017
• Study Start: January 19, 2018
• Primary Completion: March 9, 2018
• Study Completion: April 4, 2018
• Last Updated: April 17, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)