HealthyPhase 1NCT06327880
A Study to Learn About the Study Medicine Called PF-07054894 in People of Japanese Origin
A Phase 1 study of Healthy, run by Pfizer at 1 site in Belgium.
Trial summary
The purpose of this clinical study is to learn about the safety and effects of the study medicine (PF-07054894) in healthy Japanese participants. The study is seeking the following participants: Male or female Japanese participants aged 18 years or older. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteBelgium
- Study dates
- 13 May 2024to 2 Jul 2024
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male and female Japanese subjects aged 18 years or older
- Body Mass Index (BMI) of 16-32 kg/m2; and a total body weight >45 kg (100 lb)
Who cannot join
- Evidence or history of clinically significant disease or medical conditions
- Positive urine drug test or history of alcohol abuse or illicit drug use.
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Pfizer Clinical Research Unit - Brussels
Brussels, Bruxelles-capitale, Région de, B-1070
About this study
Official title: A PHASE 1, RANDOMIZED, DOUBLE BLIND, SPONSOR OPEN, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF MULTIPLE ORAL DOSES OF PF-07054894 IN HEALTHY ADULT JAPANESE PARTICIPANTS
The purpose of this clinical study is to learn about the safety and effects of the study medicine (PF-07054894) in healthy Japanese participants.
The study is seeking the following participants:
Read more
- Male or female Japanese participants aged 18 years or older. The participants should be healthy after going through some medical tests.
- Have a Body Mass Index (BMI) of 16 to 32 kilogram per meter squared; and a total body weight of more than 45 kilograms (100 pounds).
- Are willing and able to follow all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
In research, the participants in clinical studies are assigned by chance to separate groups that are given different treatments. Hence participants will be by chance assigned to receive either PF-07054894 or a harmless treatment that has no medical effect (placebo). Both these will be taken by mouth for 14 days. The total duration of the study is about 11 weeks, with a follow-up via telephone about 6 weeks after first treatment.
- Conditions
- Healthy
- Being tested
- PF-07054894 or placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-07054894 or placeboDrug
multiple oral doses of PF-07054894 for 14 days
| Study group | Role | What they receive |
|---|---|---|
| PF-07054894 | Experimental | Not described Receives: Drug: PF-07054894 or placebo |
| Placebo | Placebo comparator | Not described Receives: Drug: PF-07054894 or placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events (AE) or serious adverse events (SAE)
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious adverse event (SAE) is defined as any untoward medical occurrence at any dose that results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; results in congenital anomaly/birth defect. AEs include both SAEs and AEs.
Measured: Screening, Baseline through study completion, an average of 11 weeks
Number of participants with clinically meaningful change from baseline in laboratory tests results
Measured: Screening, Baseline, Day 2, 7 and 14
Number of participants with clinically meaningful change from baseline in vital signs
Number of participants with change from baseline in vital signs including supine blood pressure and pulse rate
Measured: Screening, Day 1, 2, 7, 14, and 15
Number of participants with clinically meaningful change from baseline in electrocardiogram (ECG) parameters
Measured: Screening, Day 1, 2, 7, 14 and 15
Maximal plasma concentration (Cmax)
The maximum observed plasma concentration (Cmax) will be observed directly from data.
Measured: Day 1 and 14
Time to Maximum Plasma Concentration (Tmax)
Tmax will be observed directly from data
Measured: Day 1 and 14
Area Under the Plasma Concentration-Time Profile From Time Zero (AUCτ) To End of Dosing Interval (AUCt)
AUCτ is summarized by dosing interval and day. Dosing interval is the interval τ between administration of doses of drug.
Measured: Day 1 and 14
Half-life of PF-07054894
terminal elimination half-life will be calculated based on the measured data
Measured: Day 14
Secondary outcomes (5)
Observed Accumulation Ratio (Rac)
Rac is calculated as, area under the curve from time zero to end of dosing interval on Day 14 (AUCtau) divided by area under the curve from time zero to end of dosing interval on Day 1 (AUCτ)
Measured: Day 14
Observed Accumulation Ratio Based on Cmax (Rac,Cmax)
Rac Cmax is calculated as, maximum observed plasma concentration on Day 14 (Cmax) divided by maximum observed plasma concentration on Day 1 (Cmax)
Measured: Day 14
Trough plasma concentrations (Ctrough)
Measured: Day 14
Apparent Volume of Distribution (Vz/F) as data permits
Vz/F is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. VZ/F after oral dose is influenced by the fraction absorbed.
Measured: Day 14
Apparent Oral Clearance (CL/F)
CL/F is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes
Measured: Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2024
- Study start13 May 2024
- Primary completion2 Jul 2024
- Study completion2 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06327880
- Sponsor's protocol ID
- C4151006
- Other IDs
- 2023-509339-17-00, 2023
- Status last verified
- Aug 2024
- First submitted
- 18 Mar 2024
- Last updated
- 5 Aug 2024
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE 1, RANDOMIZED, DOUBLE BLIND, SPONSOR OPEN, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF MULTIPLE ORAL DOSES OF PF-07054894 IN HEALTHY ADULT JAPANESE PARTICIPANTS
- ClinicalTrials.gov ID
- NCT06327880
- Acronym / sponsor ID
- C4151006
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 13 May 2024 (actual)
- Primary completion
- 2 Jul 2024 (actual)
- Study completion
- 2 Jul 2024 (actual)
- First posted
- 25 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this clinical study is to learn about the safety and effects of the study medicine (PF-07054894) in healthy Japanese participants.
The study is seeking the following participants:
- Male or female Japanese participants aged 18 years or older. The participants should be healthy after going through some medical tests.
- Have a Body Mass Index (BMI) of 16 to 32 kilogram per meter squared; and a total body weight of more than 45 kilograms (100 pounds).
- Are willing and able to follow all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
In research, the participants in clinical studies are assigned by chance to separate groups that are given different treatments. Hence participants will be by chance assigned to receive either PF-07054894 or a harmless treatment that has no medical effect (placebo). Both these will be taken by mouth for 14 days. The total duration of the study is about 11 weeks, with a follow-up via telephone about 6 weeks after first treatment.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PF-07054894 | Experimental | Drug: PF-07054894 or placebo |
| Placebo | Placebo comparator | Drug: PF-07054894 or placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy male and female Japanese subjects aged 18 years or older
- Body Mass Index (BMI) of 16-32 kg/m2; and a total body weight >45 kg (100 lb)
Key exclusion criteria (2 listed)
- Evidence or history of clinically significant disease or medical conditions
- Positive urine drug test or history of alcohol abuse or illicit drug use.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PF-07054894 or placebomultiple oral doses of PF-07054894 for 14 days | Drug | PF-07054894, Placebo |
Primary outcome
Number of participants with adverse events (AE) or serious adverse events (SAE)
Time frame: Screening, Baseline through study completion, an average of 11 weeks
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious adverse event (SAE) is defined as any untoward medical occurrence at any dose that results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; results in congenital anomaly/birth defect. AEs include both SAEs and AEs.
Number of participants with clinically meaningful change from baseline in laboratory tests results
Time frame: Screening, Baseline, Day 2, 7 and 14
Number of participants with clinically meaningful change from baseline in vital signs
Time frame: Screening, Day 1, 2, 7, 14, and 15
Number of participants with change from baseline in vital signs including supine blood pressure and pulse rate
Number of participants with clinically meaningful change from baseline in electrocardiogram (ECG) parameters
Time frame: Screening, Day 1, 2, 7, 14 and 15
Maximal plasma concentration (Cmax)
Time frame: Day 1 and 14
The maximum observed plasma concentration (Cmax) will be observed directly from data.
Time to Maximum Plasma Concentration (Tmax)
Time frame: Day 1 and 14
Tmax will be observed directly from data
Area Under the Plasma Concentration-Time Profile From Time Zero (AUCτ) To End of Dosing Interval (AUCt)
Time frame: Day 1 and 14
AUCτ is summarized by dosing interval and day. Dosing interval is the interval τ between administration of doses of drug.
Half-life of PF-07054894
Time frame: Day 14
terminal elimination half-life will be calculated based on the measured data
5 secondary outcomes
Observed Accumulation Ratio (Rac)
Time frame: Day 14
Observed Accumulation Ratio Based on Cmax (Rac,Cmax)
Time frame: Day 14
Trough plasma concentrations (Ctrough)
Time frame: Day 14
Apparent Volume of Distribution (Vz/F) as data permits
Time frame: Day 14
Apparent Oral Clearance (CL/F)
Time frame: Day 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2024.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study of Healthy, run by Pfizer at 1 site in Belgium.
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 2 inclusion and 2 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 5 Aug 2024. 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 Belgium. 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?
Number of participants with adverse events (AE) or serious adverse events (SAE) (time frame: Screening, Baseline through study completion, an average of 11 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Aug 2024.