A Single Dose Crossover Study In Healthy Subjects To Evaluate Different Formulations Of PF-06882961

Healthy Subjects Clinical Trial

Official title:

A Phase 1, Open-label Study In Healthy Subjects To Evaluate The Pharmacokinetics Of Pf-06882961 Following Single Oral Administration Of Immediate Release Tablets And An Immediate Release Oral Solution In The Fed State, And Controlled Release Tablets In The Fed And Fasted States

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03492697
• Other study ID #: C3421003
• Status: Completed
• Phase: Phase 1
• Start date: April 30, 2018
• Est. completion date: July 18, 2018

Study information

• Verified date: July 2018
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This open label study will evaluate the pharmacokinetics (PK) following single oral doses of different formulations of PF-06882961, including controlled release (CR) tablets at 2 release rates (long and short duration), an immediate release (IR) oral solution, and IR tablets, in healthy adult subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: July 18, 2018
• Est. primary completion date: July 18, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Healthy female subjects of nonchildbearing potential and/or male subjects who, at the time of screening, are between the ages of 18 and 55 years, inclusive

• Body mass index (BMI) within 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb)

• Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study

Exclusion Criteria:

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal (including pancreatitis), 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 7 drinks/week for female subjects or 14 drinks/week for male subjects 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).

• Subjects who have previously participated in prior studies with PF 06882961 as the investigational product.

• 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 QTc interval >450 msec or a QRS interval >120 msec.

• Aspartate aminotransferase (AST) level >= 1.25 × upper limit of normal (ULN);

• Alanine aminotransferase (ALT) level >= 1.25 × ULN;

• Total bilirubin level >=1.5 × ULN;

• TSH > ULN;

• HbA1c >=6.5%.

• Fertile male subjects who are unwilling or unable to use a highly effective method of contraception as outlined in the protocol for at least 28 days after the last dose of investigational product.

• Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half lives (whichever is longer) prior to the first 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.

• 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).

• Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2), or subjects with suspected MTC per the investigator's judgement.

• Unwilling or unable to comply with the criteria in the Lifestyle Requirements section of 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

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• PF-06882961 Immediate Release Tablet
Immediate Release Tablet
• PF-06882961 Controlled Release Tablet (long)
Controlled Release tablet (long)
• PF-06882961 Controlled Release Tablet (short)
Controlled Release tablet (short)
• PF-06882961 Immediate Release Solution
PF-06882961 Immediate Release solution

Locations

Country	Name	City	State
United States	Pfizer New Haven Clinical Research Unit	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Observed Plasma Concentration (Cmax) for PF-06882961		0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose in each period
Primary	Time to Maximum Observed Plasma Concentration (Tmax) for PF-06882961		0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose in each period
Primary	Area under the curve from time zero to last quantifiable concentration for PF-06882961 (AUClast)		0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose in each period
Primary	Area under the curve from time zero to extrapolated infinite time for PF-06882961 (AUCinf), as data permit	AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf).	0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose in each period
Primary	Observed Plasma Concentration for PF-06882961 at 24 hours post-dose (C24)		24 hours post dose in each period
Primary	Plasma Decay Half-Life (t1/2) for PF-06882961, as data permit	Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.	0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose in each period
Primary	Apparent clearance (CL/F) for PF-06882961, as data permit	Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood (rate at which a drug is metabolized or eliminated by normal biological processes). Calculated as Dose/AUCinf	0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose in each period
Primary	Peak-to-trough (PTR) ratio for PF-06882961	Calculated as ratio of Cmax to C24	0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose in each period
Secondary	Number of subjects with treatment-emergent adverse events (AEs)	Assessment by adverse event monitoring, 12 lead ECGs, vital signs and clinical safety laboratory measurements.	Baseline to at least 28 days after last dose
Secondary	AUClast for PF-06882961 for CR tablet (long) and IR tablet in fed state		0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose
Secondary	AUCinf for PF-06882961 for CR tablet (long) and IR tablet in fed state, as data permit		0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose
Secondary	Cmax for PF-06882961 for CR tablet (long) and IR tablet in fed state		0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose
Secondary	AUClast for PF-06882961 for CR tablet (long) in fed and fasted states		0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose
Secondary	AUCinf for PF-06882961 for CR tablet (long) in fed and fasted states, as data permit		0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose
Secondary	Cmax for PF-06882961 for CR tablet (long) in fed and fasted states		0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose

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