STUDY TO COMPARE PHARMACOKINETICS (PK) OF SINGLE ORAL DOSES OF DIFFERENT PF-06882961 FORMULATIONS IN PARTICIPANTS WHO ARE OVERWEIGHT OR HAVE OBESITY

NCT04616339

Last updated date
Study Location
Brussels Clinical Research Unit
Brussels, Bruxelles-capitale, Région DE, B-1070, Belgium
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
OBESITY
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Male and female participants must be 18 to 55 years of age, inclusive, at the time of signing the ICD.

- Male and female participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vitals and ECGs. Participants with obesity that are otherwise healthy may be enrolled in this study.

- Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.

- A total body weight >50 kg (110 lb) and BMI of 25.0 to 40.0 kg/m2 at the screening visit.

- Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICD and protocol.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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).


- History of HIV infection, hepatitis B, or hepatitis C; positive testing for HBsAg,
HBsAb, HBcAb, HCVAb or HIV. Hepatitis B vaccination is allowed.


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


- Other medical or psychiatric condition including recent (within the past year) or
active suicidal ideation/behavior or laboratory abnormality that may increase the risk
of study participation or, in the investigator's judgment, make the participant
inappropriate for the study.


- Use of prescription or nonprescription drugs and dietary and herbal supplements within
7 days or 5 halflives (whichever is longer) prior to the first dose of study
intervention.


- Use of hormone replacement therapy or oral/injectable contraceptives.


- Previous administration with an investigational drug within 30 days (or as determined
by the local requirement) or 5 half lives preceding the first dose of study
intervention used in this study (whichever is longer).


- Participants with known prior participation (ie, randomized and received at least 1
dose of investigational product) in a study involving PF 06882961.


- A positive urine drug test.


- Using a properly sized and calibrated BP cuff, screening supine BP ≥140 mm Hg
(systolic) or ≥90 mm Hg (diastolic) following at least 5 minutes of supine rest. If BP
is ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic) the BP should be repeated 2 more
times and the average of the 3 BP values should be used to determine the participant's
eligibility.


- Baseline 12 lead ECG that demonstrates clinically relevant abnormalities that may
affect participant safety or interpretation of study results (eg, baseline QTcF
interval >450 msec, complete LBBB, signs of an acute or indeterminate age myocardial
infarction, ST T interval changes suggestive of myocardial ischemia, second or third
degree AV block, or serious bradyarrhythmias or tachyarrhythmias). If the baseline
uncorrected QT interval is >450 msec, this interval should be rate corrected using the
Fridericia method and the resulting QTcF should be used for decision making and
reporting. If QTcF exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be
repeated 2 more times and the average of the 3 QTcF or QRS values should be used to
determine the participant's eligibility. Computer interpreted ECGs should be overread
by a physician experienced in reading ECGs before excluding participants.


- Participants 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; participants 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.


- HbA1c ≥6.5%;


- Fasting blood glucose ≥126 mg/dL (7 mmol/L);


- Calcitonin > ULN;


- eGFR <60 mL/min/1.73 m2 as calculated by the CKD-EPI equation.

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Advanced Information
Descriptive Information
Brief Title  ICMJE STUDY TO COMPARE PHARMACOKINETICS (PK) OF SINGLE ORAL DOSES OF DIFFERENT PF-06882961 FORMULATIONS IN PARTICIPANTS WHO ARE OVERWEIGHT OR HAVE OBESITY
Official Title  ICMJE A PHASE 1, OPEN LABEL, 4-PERIOD, 4-SEQUENCE, CROSSOVER STUDY TO COMPARE THE SINGLE DOSE PHARMACOKINETICS OF FOUR DIFFERENT FORMULATIONS OF PF-06882961 ADMINISTERED ORALLY TO OTHERWISE HEALTHY ADULT PARTICIPANTS WHO ARE OVERWEIGHT OR HAVE OBESITY
Brief Summary The purpose of the study is to evaluate the effect of formulation on relative bioavailability of PF-06882961.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE OBESITY
Intervention  ICMJE Drug: PF-06882961 100 mg
PF-06882961 100 mg will be provided in 4 different oral formulations (Treatment A,B,C,D). Participants will receive each formulation in one of 4 periods
Study Arms  ICMJE
  • Experimental: Treatment Sequence 1
    Participants will receive a single 100 mg dose of each formulation of PF-06882961 in each period as follows: Period 1 (Treatment A); Period 2 (Treatment B); Period 3 (Treatment C); Period 4 (Treatment D)
    Intervention: Drug: PF-06882961 100 mg
  • Experimental: Treatment Sequence 2
    Participants will receive a single 100 mg dose of each formulation of PF-06882961 in each period as follows: Period 1 (Treatment A); Period 2 (Treatment B); Period 3 (Treatment D); Period 4 (Treatment C).
    Intervention: Drug: PF-06882961 100 mg
  • Experimental: Treeatment Sequence 3
    Participants will receive a single 100 mg dose of each formulation of PF-06882961 in each period as follows: Period 1 (Treatment B); Period 2 (Treatment A); Period 3 (Treatment C); Period 4 (Treatment D).
    Intervention: Drug: PF-06882961 100 mg
  • Experimental: Treatment Sequence 4
    Participants will receive a single 100 mg dose of each formulation of PF-06882961 in each period as follows: Period 1 (Treatment B); Period 2 (Treatment A); Period 3 (Treatment D); Period 4 (Treatment C)
    Intervention: Drug: PF-06882961 100 mg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 30, 2020)
16
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 18, 2021
Estimated Primary Completion Date February 18, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male and female participants must be 18 to 55 years of age, inclusive, at the time of signing the ICD.
  • Male and female participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vitals and ECGs. Participants with obesity that are otherwise healthy may be enrolled in this study.
  • Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
  • A total body weight >50 kg (110 lb) and BMI of 25.0 to 40.0 kg/m2 at the screening visit.
  • Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICD and protocol.

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).
  • History of HIV infection, hepatitis B, or hepatitis C; positive testing for HBsAg, HBsAb, HBcAb, HCVAb or HIV. Hepatitis B vaccination is allowed.
  • Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2), or participants with suspected MTC per the investigator's judgement.
  • Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
  • Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 halflives (whichever is longer) prior to the first dose of study intervention.
  • Use of hormone replacement therapy or oral/injectable contraceptives.
  • Previous administration with an investigational drug within 30 days (or as determined by the local requirement) or 5 half lives preceding the first dose of study intervention used in this study (whichever is longer).
  • Participants with known prior participation (ie, randomized and received at least 1 dose of investigational product) in a study involving PF 06882961.
  • A positive urine drug test.
  • Using a properly sized and calibrated BP cuff, screening supine BP ?140 mm Hg (systolic) or ?90 mm Hg (diastolic) following at least 5 minutes of supine rest. If BP is ?140 mm Hg (systolic) or ?90 mm Hg (diastolic) the BP should be repeated 2 more times and the average of the 3 BP values should be used to determine the participant's eligibility.
  • Baseline 12 lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results (eg, baseline QTcF interval >450 msec, complete LBBB, signs of an acute or indeterminate age myocardial infarction, ST T interval changes suggestive of myocardial ischemia, second or third degree AV block, or serious bradyarrhythmias or tachyarrhythmias). If the baseline uncorrected QT interval is >450 msec, this interval should be rate corrected using the Fridericia method and the resulting QTcF should be used for decision making and reporting. If QTcF exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated 2 more times and the average of the 3 QTcF or QRS values should be used to determine the participant's eligibility. Computer interpreted ECGs should be overread by a physician experienced in reading ECGs before excluding participants.
  • Participants 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; participants 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.
    • HbA1c ?6.5%;
    • Fasting blood glucose ?126 mg/dL (7 mmol/L);
    • Calcitonin > ULN;
    • eGFR <60 mL/min/1.73 m2 as calculated by the CKD-EPI equation.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04616339
Other Study ID Numbers  ICMJE C3421010
2020-001016-24 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP