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Study of Single Ascending Doses of PF-07081532 in Healthy Adult Participants

Last updated on November 13, 2019

FOR MORE INFORMATION
Study Location
Pfizer Clinical Research Unit Brussels
Brussels, , Belgium
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
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

1. Male and female (of non-childbearing potential) participants must be 18 to 55 years of
age, inclusive, at the time of signing the informed consent document (ICD).

2. Male and female participants who are overtly healthy as determined by medical
evaluation including medical history, physical examination, including blood pressure
(BP) and pulse rate measurement, temperature, standard 12-lead ECG, telemetry and
laboratory tests.

3. Participants who are willing and able to comply with all scheduled visits, treatment
plan, laboratory tests, lifestyle considerations, and other study procedures. Note
that participants enrolling as Japanese must have 4 biological Japanese grandparents
who were born in Japan.

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

5. Capable of giving signed informed consent as described in Appendix 1, which includes
compliance with the requirements and restrictions listed in the ICD and in the
protocol.

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

1. Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal (including pancreatitis), cardiovascular, hepatic,
psychiatric, neurological, dermatological, or allergic disease (including drug
allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of
dosing).

2. Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).

3. History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C;
positive testing at screening for HIV, hepatitis B surface antigen (HBsAg), hepatitis
B core antibody (HBcAb), hepatitis B surface antibody (HBsAb) or hepatitis C antibody
(HCVAb).

4. 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.

5. 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 participant inappropriate for entry into
this study.

6. Use of prescription or nonprescription drugs and dietary and herbal supplements within
7 days or 5 half-lives (whichever is longer) prior to the first dose of
investigational product.

7. 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 investigational
product used in this study (whichever is longer).

8. A positive urine drug test at screening or admission.

9. Screening supine BP >=140 mm Hg (systolic) or >=90 mm Hg (diastolic), following at
least 5 minutes of supine rest.

10. Screening standard 12-lead single ECG that demonstrates clinically relevant
abnormalities that may affect participant safety or interpretation of study results
(eg, baseline Fridericia-corrected QT [QTcF] interval >450 msec, complete left bundle
branch block [LBBB], signs of an acute or indeterminate-age myocardial infarction,
ST-T interval changes suggestive of myocardial ischemia, second- or third-degree
atrioventricular [AV] block, or serious bradyarrhythmias or tachyarrhythmias).

11. 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%.

12. History of alcohol abuse or binge drinking and/or any other illicit drug use or
dependence within 6 months of Screening.

13. Use of tobacco/nicotine containing products more than 5 cigarettes/day.

14. Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more
within 60 days prior to dosing.

15. Unwilling or unable to comply with the criteria in the Lifestyle Considerations
section of the protocol.

16. 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
Pfizer employees, including their family members, directly involved in the conduct of
the study.

NCT04148209
Pfizer
Not yet recruiting
Study of Single Ascending Doses of PF-07081532 in Healthy Adult Participants

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Descriptive Information
Brief Title  ICMJE Study of Single Ascending Doses of PF-07081532 in Healthy Adult Participants
Official Title  ICMJE A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED STUDY TO ASSESS THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF SINGLE ASCENDING ORAL DOSES OF PF-07081532 IN HEALTHY ADULT PARTICIPANTS
Brief SummaryThe purpose of this study is to evaluate the safety, tolerability and pharmacokinetics (PK) of single ascending oral doses of PF-07081532 in healthy adult participants.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
This study is a double-blinded (investigator- and participant-blinded), sponsor-open, randomized, single-ascending oral dose, 4-period crossover, placebo substitution design in 2 interleaving cohorts of healthy adult participants. An additional cohort, enrolling healthy adult participants in up to 4 crossover periods, may be included to permit assessment of any of the following: repeat of a previously administered dose level; studying additional dose levels as dictated by the evaluated safety, tolerability or PK of earlier dose levels; or any other assessment needed to meet the objectives of this study. A cohort enrolling Japanese participants to receive PF-07081532 or placebo in up to 3 periods, may be included.

Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science

Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: PF-07081532
    Participants will receive single ascending doses PF-07081532
  • Drug: Placebo
    Participants will receive placebo
Study Arms  ICMJE
  • Experimental: Treatment
    Participants receiving PF-07081532
    Intervention: Drug: PF-07081532
  • Placebo Comparator: Placebo
    Participants receiving Placebo
    Intervention: Drug: Placebo
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 Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: October 30, 2019)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 23, 2020
Estimated Primary Completion DateMarch 23, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male and female (of non-childbearing potential) participants must be 18 to 55 years of age, inclusive, at the time of signing the informed consent document (ICD).
  2. Male and female participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, including blood pressure (BP) and pulse rate measurement, temperature, standard 12-lead ECG, telemetry and laboratory tests.
  3. Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures. Note that participants enrolling as Japanese must have 4 biological Japanese grandparents who were born in Japan.
  4. Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).
  5. Capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the ICD and in the protocol.

Exclusion Criteria:

  1. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal (including pancreatitis), cardiovascular, hepatic, psychiatric, neurological, dermatological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
  2. Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
  3. History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing at screening for HIV, hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), hepatitis B surface antibody (HBsAb) or hepatitis C antibody (HCVAb).
  4. 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.
  5. 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 participant inappropriate for entry into this study.
  6. Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of investigational product.
  7. 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 investigational product used in this study (whichever is longer).
  8. A positive urine drug test at screening or admission.
  9. Screening supine BP >=140 mm Hg (systolic) or >=90 mm Hg (diastolic), following at least 5 minutes of supine rest.
  10. Screening standard 12-lead single ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results (eg, baseline Fridericia-corrected QT [QTcF] interval >450 msec, complete left bundle branch block [LBBB], signs of an acute or indeterminate-age myocardial infarction, ST-T interval changes suggestive of myocardial ischemia, second- or third-degree atrioventricular [AV] block, or serious bradyarrhythmias or tachyarrhythmias).
  11. 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; TSH > ULN; HbA1c >= 6.5%.
  12. History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening.
  13. Use of tobacco/nicotine containing products more than 5 cigarettes/day.
  14. Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing.
  15. Unwilling or unable to comply with the criteria in the Lifestyle Considerations section of the protocol.
  16. 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 Pfizer employees, including their family members, directly involved in the conduct of the study.
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 NCT04148209
Other Study ID Numbers  ICMJE C3991001
2019-003012-30 ( EudraCT Number )
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product:No
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/da....
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateOctober 2019

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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