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HealthyPhase 1NCT04459767

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

A Phase 1 study testing Vupanorsen in people with Healthy, run by Pfizer at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 20 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Vupanorsen
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
12 participants
Where
1 siteJapan
Study dates
6 Aug 2020to 15 Dec 2020
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Male and female participants must be 20 to 65 years of age, inclusive, at the time of signing the ICD.
  • Participants must have four Japanese grandparents born in Japan.
  • 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.
  • Fasting TG >= 90 mg/dL at Screening
  • Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
  • BMI of 17.5 to 35.0 kg/m2; and a total body weight >50 kg (110 lb)
  • 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.

Who cannot join

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease.
  • History of HIV infection, hepatitis B, or hepatitis C; positive testing for HIV, HBsAg, or HCVAb.
  • 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.
  • History of allergic or anaphylactic reaction.
  • 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.
  • 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).
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  • A positive urine drug test.
  • 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.
  • 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.
  • History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening.
  • 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.
  • History of sensitivity to heparin or heparin induced thrombocytopenia.
  • History of substance abuse within 12 months of the screening visit.
  • Pregnant females; breastfeeding females.
  • Unwilling or unable to comply with the criteria in the Lifestyle Considerations section of this protocol.
  • 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.

Trial locations and contacts

1 site in 1 country.

Japan1 site

  • P-one Clinic

    Hachioji-shi, Tokyo, 192-0071

Other trials in Japan

About this study

Official title: 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

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.

Conditions
Healthy
Being tested
Vupanorsen, Placebo
Keywords
Triglycerides

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VupanorsenDrug

    80 mg subcutaneous injection

  • PlaceboDrug

    Subcutaneous injection

Study groups in NCT04459767
Study groupRoleWhat they receive
Vupanorsen 80 milligram (mg)ExperimentalParticipants will receive one, 0.8 milliliter (mL) subcutaneous injection with vupanorsen 100 mg/mL solution
Receives: Drug: Vupanorsen
Vupanorsen 160 mgExperimentalParticipants will receive two, 0.8 mL subcutaneous injections with vupanorsen 100 mg/mL solution
Receives: Drug: Vupanorsen
PlaceboPlacebo comparatorParticipants 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.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of treatment related adverse events

    Measured: Day 0-90

  2. Incidence of abnormal and clinically relevant changes in electrocardiogram

    Measured: Day 0-90

  3. Incidence and magnitude of abnormal laboratory findings

    Measured: Day 0-90

  4. Incidence of abnormal and clinically relevant changes in pulse rate

    Measured: Day 0-90

  5. Incidence of abnormal and clinically relevant changes in supine blood pressure

    Measured: Day 0-90

Secondary outcomes (18)

  1. Maximum observed plasma concentration (Cmax)

    Measured: Day 0-90

  2. Time to reach maximum observed plasma concentration (Tmax)

    Measured: Day 0-90

  3. Area under the plasma concentration-time profile from time zero to 24 hours post-dose (AUC24h)

    Measured: Day 0-90

  4. Area under the plasma concentration-time profile from time zero to 48 hours post-dose (AUC48h)

    Measured: Day 0-90

  5. Area under the plasma concentration-time profile from time zero to the last measurable concentration (AUClast)

    Measured: Day 0-90

  6. Area under the plasma concentration-time profile from time zero to infinity (AUCinf)

    Measured: Day 0-90

  7. Terminal elimination half life (t1/2)

    Measured: Day 0-90

  8. Apparent volume of distribution (Vz/F)

    Measured: Day 0-90

  9. Apparent clearance (CL/F)

    Measured: Day 0-90

  10. Percentage changes from baseline in serum angiopoietin-like protein 3

    Measured: Day 0-90

  11. Percentage changes from baseline in total cholesterol

    Measured: Day 0-90

  12. Percentage changes from baseline in low density lipoprotein cholesterol

    Measured: Day 0-90

  13. Percentage changes from baseline in non-high-density lipoprotein cholesterol

    Measured: Day 0-90

  14. Percentage changes from baseline in very low density lipoprotein cholesterol

    Measured: Day 0-90

  15. Percentage changes from baseline in triglyceride

    Measured: Day 0-90

  16. Percentage changes from baseline in apolipoprotein A-1

    Measured: Day 0-90

  17. Percentage changes from baseline in apolipoprotein B total

    Measured: Day 0-90

  18. Percentage changes from baseline in apolipoprotein C-III

    Measured: Day 0-90

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2020
  2. Study start6 Aug 2020
  3. Primary completion15 Dec 2020
  4. Study completion15 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Sequential
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04459767
Sponsor's protocol ID
C4491006
Status last verified
Dec 2020
First submitted
1 Jul 2020
Last updated
22 Dec 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: 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/data\_requests.

Publications

  • Fukuhara K, Furihata K, Matsuoka N, Itamura R, Ramos V, Hagi T, Kalluru H, Bramson C, Terra SG, Liu J. A multi-purpose Japanese phase I study in the global development of vupanorsen: Randomized, placebo-controlled, single-ascending dose study in adults. Clin Transl Sci. 2023 May;16(5):886-897. doi: 10.1111/cts.13498. Epub 2023 Mar 31.

    PubMed 37002654

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Vupanorsen in people with Healthy, run by Pfizer at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of treatment related adverse events (time frame: Day 0-90). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04459767, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2020.

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