Investigation Of Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Single Doses Of Vupanorsen In Japanese Healthy Adult Participants With Elevated Triglycerides
NCT04459767
ABOUT THIS STUDY
FOR MORE INFORMATION
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Pfizer Clinical Trials Contact Center
1-800-718-1021
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.
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 11. History of alcohol abuse or binge drinking and/or any other illicit drug use or 12. Blood donation (excluding plasma donations and platelet donations) of approximately 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 17. Investigator site staff or Pfizer employees directly involved in the conduct of the
syndrome may have direct bilirubin measured and would be eligible for this study
provided the direct bilirubin level is=
dependence within 6 months of Screening.
400 mL within 3 months or >=200 mL within a month prior to dosing. Additionally,
approximately >=400 mL within 4 months for female participants.
section of this protocol.
study, site staff otherwise supervised by the investigator, and their respective
family members.
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Descriptive Information | |||||||
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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 |
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Study Arms ICMJE |
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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 | Completed | ||||||
Actual Enrollment ICMJE | 12 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Actual Study Completion Date ICMJE | December 15, 2020 | ||||||
Actual Primary Completion Date | December 15, 2020 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 20 Years to 65 Years (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | Yes | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
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 |
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IPD Sharing Statement ICMJE |
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Responsible Party | Pfizer | ||||||
Study Sponsor ICMJE | Pfizer | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Pfizer | ||||||
Verification Date | December 2020 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |