HealthyPhase 1NCT06190561
A Study to Learn How Different Products of the Study Medicine Called PF-07940367 Are Taken up Into the Blood in Healthy Adults
A Phase 1 study testing PF-07940367 in people with Healthy, run by Pfizer at 1 site in United States.
Trial summary
The purpose of this study is to compare two finished products of PF-07940367 in terms of the uptake into the blood stream. This study is seeking participants who are: Healthy male or female participants aged 18 years or older. All participants in this study will receive PF-07940367 once by mouth. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- PF-07940367
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2024to 7 May 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
- Male and female participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
- BMI of 16-32 kg/m2; and a total body weight >50 kg (110 lb).
- Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations and other study procedures.
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent document (ICD) and in the protocol.
Who cannot join
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
- Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
- History of human immunodeficiency virus (HIV) infection, hepatitis A, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HBsAg), or hepatitis B surface antigen (HCVAb). Hepatitis B vaccination is allowed.
- Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality or other conditions that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
- Use of prescription or nonprescription drug, 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 product (drug or vaccine) within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer). Participation in studies of other investigational products (drug or vaccine) at any time during their participation in this study.
- A positive urine drug test.
Trial locations and contacts
1 site in 1 country.
United States1 site
Anaheim Clinical Trials, LLC
Anaheim, California, 92801
About this study
Official title: A PHASE 1, OPEN-LABEL, RANDOMIZED, SINGLE-DOSE, PARALLEL DESIGN, STUDY TO EVALUATE PHARMACOKINETIC COMPARABILITY OF TWO PF-07940367 FILM-COATED TABLET FORMULATIONS ADMINISTERED AS 150 MG UNDER FASTED CONDITIONS IN HEALTHY PARTICIPANTS
The purpose of this study is to compare two finished products of PF-07940367 in terms of the uptake into the blood stream.
This study is seeking participants who are:
Read more
- Healthy male or female participants aged 18 years or older.
All participants in this study will receive PF-07940367 once by mouth. The participants may receive different tablets by mouth for PF-07940367.
The study will compare experiences of people receiving two different products of PF-07940367. This will help understand how much PF-07940367 is taken up into the blood for each product given.
Participants will take part in the study for about 112 days. During this time, participants will have to stay onsite for 5 days. There will be up to 2 additional onsite study visits and 3 remote (telephone call) study visits.
- Conditions
- Healthy
- Being tested
- PF-07940367
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-07940367Drug
Participants to receive a single dose of PF-07940367 product II 150 mg by mouth
PF-07940367Drug
Participants to receive a single dose of PF-07940367 product I 150 mg by mouth
| Study group | Role | What they receive |
|---|---|---|
| Treatment A: PF-07940367 Product II | Experimental | tablet by mouth Receives: Drug: PF-07940367 |
| Treatment B: PF-07940367 Product I | Experimental | tablet by mouth Receives: Drug: PF-07940367 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the whole blood concentration versus time curve (AUC) from time zero (pre-dose) to 336 hours (AUC336) of PF-07940367 dose to evaluate pharmacokinetic comparability of two PF-07940367 products
Measured: 0 hours (pre-dose) to 336 hours post-PF-07940367 dose
Secondary outcomes (7)
Number of Participants With Treatment-Emergent Adverse Events (AEs)
Measured: From baseline up to 56 days after PF-07940367 dose
Number of Participants With Clinically Significant Laboratory Abnormalities
Measured: From baseline up to 336 hours after PF-07940367 dose
Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings
Measured: From baseline up to 96 hours after PF-07940367 dose
Number of Participants With Clinically Significant Vital Signs
Measured: From baseline up to 336 hours after PF-07940367 dose
Maximum Observed Whole Blood Concentration (Cmax) of PF-07940367 for two PF-07940367 products
Measured: 0 hours (pre-dose) to 336 hours post-PF-07940367 dose
Area under the whole blood concentration versus time curve (AUC) from time zero (pre-dose) to the last quantifiable concentration (AUClast) of PF-07940367 for two PF-07940367 products
Measured: 0 hours (pre-dose) to 336 hours post-PF-07940367 dose
Time to Maximum Observed Whole Blood Concentration (Tmax) of PF-07940367 for two PF-07940367 products
Measured: 0 hours (pre-dose) to 336 hours post-PF-07940367 dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start15 Jan 2024
- Primary completion7 May 2024
- Study completion7 May 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 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
- NCT06190561
- Sponsor's protocol ID
- C5351008
- Other IDs
- GBT BEFE (adult formulation)
- Status last verified
- Jun 2024
- First submitted
- 19 Dec 2023
- Last updated
- 13 Jun 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 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE 1, OPEN-LABEL, RANDOMIZED, SINGLE-DOSE, PARALLEL DESIGN, STUDY TO EVALUATE PHARMACOKINETIC COMPARABILITY OF TWO PF-07940367 FILM-COATED TABLET FORMULATIONS ADMINISTERED AS 150 MG UNDER FASTED CONDITIONS IN HEALTHY PARTICIPANTS
- ClinicalTrials.gov ID
- NCT06190561
- Acronym / sponsor ID
- C5351008
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 7 May 2024 (actual)
- Study completion
- 7 May 2024 (actual)
- First posted
- 5 Jan 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 study is to compare two finished products of PF-07940367 in terms of the uptake into the blood stream.
This study is seeking participants who are:
- Healthy male or female participants aged 18 years or older.
All participants in this study will receive PF-07940367 once by mouth. The participants may receive different tablets by mouth for PF-07940367.
The study will compare experiences of people receiving two different products of PF-07940367. This will help understand how much PF-07940367 is taken up into the blood for each product given.
Participants will take part in the study for about 112 days. During this time, participants will have to stay onsite for 5 days. There will be up to 2 additional onsite study visits and 3 remote (telephone call) study visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment A: PF-07940367 Product II | Experimental | Drug: PF-07940367tablet by mouth |
| Treatment B: PF-07940367 Product I | Experimental | Drug: PF-07940367tablet by mouth |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
- BMI of 16-32 kg/m2; and a total body weight >50 kg (110 lb).
- Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations and other study procedures.
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent document (ICD) and in the protocol.
Key exclusion criteria (7 listed)
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
- Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
- History of human immunodeficiency virus (HIV) infection, hepatitis A, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HBsAg), or hepatitis B surface antigen (HCVAb). Hepatitis B vaccination is allowed.
- Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality or other conditions that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
- Use of prescription or nonprescription drug, dietary and herbal supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study intervention.
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-07940367Participants to receive a single dose of PF-07940367 product II 150 mg by mouth | Drug | Treatment A: PF-07940367 Product II |
| PF-07940367Participants to receive a single dose of PF-07940367 product I 150 mg by mouth | Drug | Treatment B: PF-07940367 Product I |
Primary outcome
Area under the whole blood concentration versus time curve (AUC) from time zero (pre-dose) to 336 hours (AUC336) of PF-07940367 dose to evaluate pharmacokinetic comparability of two PF-07940367 products
Time frame: 0 hours (pre-dose) to 336 hours post-PF-07940367 dose
7 secondary outcomes
Number of Participants With Treatment-Emergent Adverse Events (AEs)
Time frame: From baseline up to 56 days after PF-07940367 dose
Number of Participants With Clinically Significant Laboratory Abnormalities
Time frame: From baseline up to 336 hours after PF-07940367 dose
Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings
Time frame: From baseline up to 96 hours after PF-07940367 dose
Number of Participants With Clinically Significant Vital Signs
Time frame: From baseline up to 336 hours after PF-07940367 dose
Maximum Observed Whole Blood Concentration (Cmax) of PF-07940367 for two PF-07940367 products
Time frame: 0 hours (pre-dose) to 336 hours post-PF-07940367 dose
Area under the whole blood concentration versus time curve (AUC) from time zero (pre-dose) to the last quantifiable concentration (AUClast) of PF-07940367 for two PF-07940367 products
Time frame: 0 hours (pre-dose) to 336 hours post-PF-07940367 dose
Time to Maximum Observed Whole Blood Concentration (Tmax) of PF-07940367 for two PF-07940367 products
Time frame: 0 hours (pre-dose) to 336 hours post-PF-07940367 dose
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 13 Jun 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 testing PF-07940367 in people with Healthy, run by Pfizer at 1 site in United States.
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 4 inclusion and 7 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 13 Jun 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 United States. 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. 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?
Area under the whole blood concentration versus time curve (AUC) from time zero (pre-dose) to 336 hours (AUC336) of PF-07940367 dose to evaluate pharmacokinetic comparability of two PF-07940367 products (time frame: 0 hours (pre-dose) to 336 hours post-PF-07940367 dose). 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 13 Jun 2024.