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

NCT ID: NCT03372044

Last Updated: 2018-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-19
• Study Completion Date: 2018-04-04

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

PF-06865571

Treatment

Group Type: EXPERIMENTAL

PF-06865571 Immediate release suspension

Intervention Type: DRUG

Suspension

PF-06865571 Slow release MR tablets

Intervention Type: DRUG

Modified release tablets

PF-06865571 Fast release MR tablets

Intervention Type: DRUG

Modified release tablets

PF-06865571 Immediate release tablets

Intervention Type: DRUG

Immediate release tablets

Interventions

PF-06865571 Immediate release suspension

Suspension

Intervention Type: DRUG

PF-06865571 Slow release MR tablets

Modified release tablets

Intervention Type: DRUG

PF-06865571 Fast release MR tablets

Modified release tablets

Intervention Type: DRUG

PF-06865571 Immediate release tablets

Immediate release tablets

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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
• Subjects who are investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.
• Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
• Subjects who have previously participated in prior studies with PF 06865571 as the investigational product.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Pfizer Clinical Research Unit

Brussels, , Belgium

Countries

Belgium

Related Links

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=C2541003&StudyName=A+Phase+1%2C+Open+Label+Study+In+Healthy+Subjects+To+Investigate+The+Pharmacokinetics+Of+Pf+06865571+Following+Single+Oral+Administration+Of+Immediate+And+Modified+Release+Tablets+Compared+To+Immediate+Release+Oral+Suspension+Under+Fed+Conditions

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Other Identifiers

2017-003797-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

C2541003

Identifier Type: -

Identifier Source: org_study_id