Investigation Of Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Single Doses Of Vupanorsen In Japanese Healthy Adult Participants With Elevated Triglycerides

NCT04459767

Last updated date
Study Location
P-one Clinic
Hachioji-shi, Tokyo, 192-0071, Japan
Contact
1-800-718-1021

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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
20-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1. Male and female participants must be 20 to 65 years of age, inclusive, at the time of signing the ICD.

2. Participants must have four Japanese grandparents born in Japan.

3. Male and female participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests (except for TG levels), and 12 lead ECG monitoring.

4. Fasting TG >= 90 mg/dL at Screening

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

6. BMI of 17.5 to 35.0 kg/m2; and a total body weight >50 kg (110 lb)

7. 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 this 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, cardiovascular, hepatic, psychiatric, neurological, or
allergic disease.


2. History of HIV infection, hepatitis B, or hepatitis C; positive testing for HIV,
HBsAg, or HCVAb.


3. 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.


4. History of allergic or anaphylactic reaction.


5. 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 study
intervention.


6. Previous administration with an investigational drug within 4 months or 5 half lives
preceding the first dose of study intervention used in this study (whichever is
longer).


7. A positive urine drug test.


8. 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.


9. Baseline 12 lead ECG that demonstrates clinically relevant abnormalities that may
affect participant safety or interpretation of study results.


10. 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:


- AST or ALT level >=1.25 × 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=

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


12. Blood donation (excluding plasma donations and platelet donations) of approximately
400 mL within 3 months or >=200 mL within a month prior to dosing. Additionally,
approximately >=400 mL within 4 months for female participants.


13. History of sensitivity to heparin or heparin induced thrombocytopenia.


14. History of substance abuse within 12 months of the screening visit.


15. Pregnant females; breastfeeding females.


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


17. Investigator site staff or Pfizer employees directly involved in the conduct of the
study, site staff otherwise supervised by the investigator, and their respective
family members.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Investigation Of Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Single Doses Of Vupanorsen In Japanese Healthy Adult Participants With Elevated Triglycerides
Official Title  ICMJE A PHASE 1, RANDOMIZED, DOUBLE-BLIND, THIRD-PARTY OPEN, PLACEBO-CONTROLLED, SINGLE ASCENDING DOSE STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF PF-07285557 (VUPANORSEN) ADMINISTERED SUBCUTANEOUSLY IN JAPANESE HEALTHY ADULTS WITH ELEVATED TRIGLYCERIDES
Brief Summary This is a Phase 1, randomized, double blind, third party open (i.e., participant blind, investigator blind and sponsor open), placebo controlled, single ascending dose study to investigate the safety, tolerability, pharmacokinetic and pharmacodynamics of vupanorsen in Japanese healthy adult participants with elevated triglycerides.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: Vupanorsen
    80 mg subcutaneous injection
  • Drug: Placebo
    Subcutaneous injection
Study Arms  ICMJE
  • Experimental: Vupanorsen 80 milligram (mg)
    Participants will receive one, 0.8 milliliter (mL) subcutaneous injection with vupanorsen 100 mg/mL solution
    Intervention: Drug: Vupanorsen
  • Experimental: Vupanorsen 160 mg
    Participants will receive two, 0.8 mL subcutaneous injections with vupanorsen 100 mg/mL solution
    Intervention: Drug: Vupanorsen
  • Placebo Comparator: Placebo

    Participants in Cohort 1 (vupanorsen 80 mg) will receive one 0.8 mL subcutaneous injection with 0.9% sodium chloride in water.

    Participants in Cohort 2 (vupanorsen 160 mg) will receive two 0.8 mL subcutaneous injections with 0.9% sodium chloride in water.

    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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 1, 2020)
12
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 29, 2020
Estimated Primary Completion Date November 29, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male and female participants must be 20 to 65 years of age, inclusive, at the time of signing the ICD.
  2. Participants must have four Japanese grandparents born in Japan.
  3. Male and female participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests (except for TG levels), and 12 lead ECG monitoring.
  4. Fasting TG >= 90 mg/dL at Screening
  5. Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
  6. BMI of 17.5 to 35.0 kg/m2; and a total body weight >50 kg (110 lb)
  7. 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 this protocol.

Exclusion Criteria:

  1. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease.
  2. History of HIV infection, hepatitis B, or hepatitis C; positive testing for HIV, HBsAg, or HCVAb.
  3. 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.
  4. History of allergic or anaphylactic reaction.
  5. 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 study intervention.
  6. Previous administration with an investigational drug within 4 months or 5 half lives preceding the first dose of study intervention used in this study (whichever is longer).
  7. A positive urine drug test.
  8. 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.
  9. Baseline 12 lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results.
  10. 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:

    • AST or ALT level >=1.25 × 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.
  11. History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening.
  12. Blood donation (excluding plasma donations and platelet donations) of approximately 400 mL within 3 months or >=200 mL within a month prior to dosing. Additionally, approximately >=400 mL within 4 months for female participants.
  13. History of sensitivity to heparin or heparin induced thrombocytopenia.
  14. History of substance abuse within 12 months of the screening visit.
  15. Pregnant females; breastfeeding females.
  16. Unwilling or unable to comply with the criteria in the Lifestyle Considerations section of this protocol.
  17. Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 20 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04459767
Other Study ID Numbers  ICMJE C4491006
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
Product Manufactured in and Exported from the U.S.: Yes
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 August 2020

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