- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03492697
A Single Dose Crossover Study In Healthy Subjects To Evaluate Different Formulations Of PF-06882961
July 27, 2018 updated by: Pfizer
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
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Connecticut
-
New Haven, Connecticut, United States, 06511
- Pfizer New Haven Clinical Research Unit
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: PF-06882961
|
Immediate Release Tablet
Controlled Release tablet (long)
Controlled Release tablet (short)
PF-06882961 Immediate Release solution
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum Observed Plasma Concentration (Cmax) for PF-06882961
Time Frame: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose in each period
|
0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose in each period
|
|
Time to Maximum Observed Plasma Concentration (Tmax) for PF-06882961
Time Frame: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose in each period
|
0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose in each period
|
|
Area under the curve from time zero to last quantifiable concentration for PF-06882961 (AUClast)
Time Frame: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose in each period
|
0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose in each period
|
|
Area under the curve from time zero to extrapolated infinite time for PF-06882961 (AUCinf), as data permit
Time Frame: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose in each period
|
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
|
Observed Plasma Concentration for PF-06882961 at 24 hours post-dose (C24)
Time Frame: 24 hours post dose in each period
|
24 hours post dose in each period
|
|
Plasma Decay Half-Life (t1/2) for PF-06882961, as data permit
Time Frame: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose in each period
|
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
|
Apparent clearance (CL/F) for PF-06882961, as data permit
Time Frame: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose in each period
|
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
|
Peak-to-trough (PTR) ratio for PF-06882961
Time Frame: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose in each period
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of subjects with treatment-emergent adverse events (AEs)
Time Frame: Baseline to at least 28 days after last dose
|
Assessment by adverse event monitoring, 12 lead ECGs, vital signs and clinical safety laboratory measurements.
|
Baseline to at least 28 days after last dose
|
AUClast for PF-06882961 for CR tablet (long) and IR tablet in fed state
Time Frame: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose
|
0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose
|
|
AUCinf for PF-06882961 for CR tablet (long) and IR tablet in fed state, as data permit
Time Frame: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose
|
0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose
|
|
Cmax for PF-06882961 for CR tablet (long) and IR tablet in fed state
Time Frame: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose
|
0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose
|
|
AUClast for PF-06882961 for CR tablet (long) in fed and fasted states
Time Frame: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose
|
0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose
|
|
AUCinf for PF-06882961 for CR tablet (long) in fed and fasted states, as data permit
Time Frame: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose
|
0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose
|
|
Cmax for PF-06882961 for CR tablet (long) in fed and fasted states
Time Frame: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose
|
0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
April 30, 2018
Primary Completion (ACTUAL)
July 18, 2018
Study Completion (ACTUAL)
July 18, 2018
Study Registration Dates
First Submitted
April 3, 2018
First Submitted That Met QC Criteria
April 3, 2018
First Posted (ACTUAL)
April 10, 2018
Study Record Updates
Last Update Posted (ACTUAL)
July 30, 2018
Last Update Submitted That Met QC Criteria
July 27, 2018
Last Verified
July 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- C3421003
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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