HealthyPhase 1NCT06661694
A Study to Learn How Different Tablets of the Study Medicine Mevrometostat Are Taken up Into the Blood in Healthy Adults
A Phase 1 study testing Treatment A, Treatment B and Treatment C in people with Healthy, run by Pfizer at 1 site in Belgium.
Trial summary
The purpose of the study is to compare the amount of mevrometostat available from four different tablet formulations, taken with food, in healthy adult participants. This study is seeking male or female participants who: are 18 years or older are healthy as decided by medical tests. 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?
- Treatment A, Treatment B and Treatment C
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteBelgium
- Study dates
- 28 Apr 2025to 9 Sep 2025
- 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
- Participants ≥18 years of age, inclusive, at screening.
- Male and female participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs and 12-lead ECGs.
- BMI of 16-32 kg/m2; and a total body weight >50 kg (110 lb)
- Evidence of a personally signed and dated ICD indicating that the participant has been informed of all pertinent aspects of the study.
- Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
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) or prior allergic reaction to any component of mevrometostat.
- Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
- History of HIV infection, hepatitis B, or hepatitis C; positive testing for HIV, HBsAg, HBsAb, HBcAb, or 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.
- Previous administration with an investigational product (drug or vaccine) within 30 days (or as determined by the local requirement) or 5 halflives 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 participation in this study.
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, OPEN-LABEL, 4-PERIOD, CROSSOVER, SINGLE-DOSE STUDY IN HEALTHY PARTICIPANTS TO ESTIMATE THE EFFECT OF TABLET FORMULATION ON THE RELATIVE BIOAVAILABILITY OF MEVROMETOSTAT (PF-06821497)
The purpose of the study is to compare the amount of mevrometostat available from four different tablet formulations, taken with food, in healthy adult participants.
This study is seeking male or female participants who:
Read more
- are 18 years or older
- are healthy as decided by medical tests.
- have a Body mass index (BMI) of 16 to 32 kilogram per meter squared
- a total body weight of more than 50 kilograms (110 pounds).
All participants will take part in 4 study periods to receive 4 different treatments, which are assigned in a random order. There will also be a 5-day gap between each study period. This is done so that the medicine is passed out of the body before the start of the next period.
Each treatment consists of a single dose of mevrometostat (PF-06821497), and the treatments differ only by tablet formulation.
How the medicine is processed in the body will be studied after giving the medicines to the participants. This will be done by collecting blood samples after giving each of these tablets. The results will be used to see the effect of tablet formulation on the amount of mevrometostat (PF-06821497) available in the blood of the participants.
Participants will be in the study for about 12 weeks.
- Conditions
- Healthy
- Being tested
- Treatment A, Treatment B, Treatment C, Treatment D
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment ADrug
Also called PF-06821497
Single 875 mg dose of mevrometostat standard tablet formulation
Treatment BDrug
Also called PF-06821497
Single 875 mg dose of mevrometostat alternative tablet formulation
Treatment CDrug
Also called PF-06821497
Single 875 mg dose of mevrometostat alternative tablet formulation
Treatment DDrug
Also called PF-06821497
Single 875 mg dose of mevrometostat alternative tablet formulation
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | Participants will receive a single 875 mg dose of Treatment A on Day 1 of Period 1, followed by a single 875 mg dose of Treatment B on Day 1 of Period 2, followed by a single 875 mg dose of Treatment C on Day 1 of Period 3, followed by a single 875 mg dose of Treatment D on Day 1 of Period 4. Receives: Drug: Treatment A; Drug: Treatment B; Drug: Treatment C; Drug: Treatment D |
| Sequence 2 | Experimental | Participants will receive a single 875 mg dose of Treatment B on Day 1 of Period 1, followed by a single 875 mg dose of Treatment D on Day 1 of Period 2, followed by a single 875 mg dose of Treatment A on Day 1 of Period 3, followed by a single 875 mg dose of Treatment C on Day 1 of Period 4. Receives: Drug: Treatment A; Drug: Treatment B; Drug: Treatment C; Drug: Treatment D |
| Sequence 3 | Experimental | Participants will receive a single 875 mg dose of Treatment C on Day 1 of Period 1, followed by a single 875 mg dose of Treatment A on Day 1 of Period 2, followed by a single 875 mg dose of Treatment D on Day 1 of Period 3, followed by a single 875 mg dose of Treatment B on Day 1 of Period 4. Receives: Drug: Treatment A; Drug: Treatment B; Drug: Treatment C; Drug: Treatment D |
| Sequence 4 | Experimental | Participants will receive a single 875 mg dose of Treatment D on Day 1 of Period 1, followed by a single 875 mg dose of Treatment C on Day 1 of Period 2, followed by a single 875 mg dose of Treatment B on Day 1 of Period 3, followed by a single 875 mg dose of Treatment A on Day 1 of Period 4. Receives: Drug: Treatment A; Drug: Treatment B; Drug: Treatment C; Drug: Treatment D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Concentration (Cmax) of Mevrometostat (Formulation 1)
To estimate the bioavailability of a single 875 mg dose of mevrometostat (Formulation 2) relative to a single 875 mg dose of mevrometostat (Formulation 1) under fed conditions in healthy adult participants.
Measured: Period 1-4: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hour(s) post-dose
Maximum Observed Plasma Concentration (Cmax) of Mevrometostat (Formulation 2)
To estimate the bioavailability of a single 875 mg dose of mevrometostat (Formulation 2) relative to a single 875 mg dose of mevrometostat (Formulation 1) under fed conditions in healthy adult participants.
Measured: Period 1-4: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hour(s) post-dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of Mevrometostat (Formulation 1)
To estimate the bioavailability of a single 875 mg dose of mevrometostat (Formulation 2) relative to a single 875 mg dose of mevrometostat (Formulation 1) under fed conditions in healthy adult participants.
Measured: Period 1-4: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hour(s) post-dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of Mevrometostat (Formulation 2)
To estimate the bioavailability of a single 875 mg dose of mevrometostat (Formulation 2) relative to a single 875 mg dose of mevrometostat (Formulation 1) under fed conditions in healthy adult participants.
Measured: Period 1-4: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hour(s) post-dose
Secondary outcomes (8)
Maximum Observed Plasma Concentration (Cmax) of Mevrometostat (Formulation 3)
To estimate the bioavailability of a single 875 mg dose of mevrometostat (Formulation 3) relative to a single 875 mg dose of mevrometostat (Formulation 2) and to estimate the bioavailability of a single 875 mg dose of mevrometostat (Formulation 4) relative to a single 875 mg dose of mevrometostat (Formulation 2) under fed conditions in healthy adult participants.
Measured: Period 1-4: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hour(s) post-dose
Maximum Observed Plasma Concentration (Cmax) of Mevrometostat (Formulation 4)
To estimate the bioavailability of a single 875 mg dose of mevrometostat (Formulation 3) relative to a single 875 mg dose of mevrometostat (Formulation 2) and to estimate the bioavailability of a single 875 mg dose of mevrometostat (Formulation 4) relative to a single 875 mg dose of mevrometostat (Formulation 2) under fed conditions in healthy adult participants.
Measured: Period 1-4: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hour(s) post-dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of Mevrometostat (Formulation 3)
To estimate the bioavailability of a single 875 mg dose of mevrometostat (Formulation 3) relative to a single 875 mg dose of mevrometostat (Formulation 2) and to estimate the bioavailability of a single 875 mg dose of mevrometostat (Formulation 4) relative to a single 875 mg dose of mevrometostat (Formulation 2) under fed conditions in healthy adult participants.
Measured: Period 1-4: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hour(s) post-dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of Mevrometostat (Formulation 4)
To estimate the bioavailability of a single 875 mg dose of mevrometostat (Formulation 3) relative to a single 875 mg dose of mevrometostat (Formulation 2) and to estimate the bioavailability of a single 875 mg dose of mevrometostat (Formulation 4) relative to a single 875 mg dose of mevrometostat (Formulation 2) under fed conditions in healthy adult participants.
Measured: Period 1-4: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hour(s) post-dose
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
To evaluate the safety and tolerability of mevrometostat when administered as a tablet formulation to healthy participants.
Measured: Time the participant provides informed consent through and including follow-up contact occurring 28-35 calendar days after the lasts administration of the study intervention.
Number of Participants With Clinical Laboratory Abnormalities
To evaluate the safety and tolerability of mevrometostat when administered as a tablet formulation to healthy participants.
Measured: Time the participant provides informed consent through and including follow-up contact occurring 28-35 calendar days after the lasts administration of the study intervention.
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
To evaluate the safety and tolerability of mevrometostat when administered as a tablet formulation to healthy participants.
Measured: Time the participant provides informed consent through and including follow-up contact occurring 28-35 calendar days after the lasts administration of the study intervention.
Number of Participants With Electrocardiogram (ECG) Abnormalities
To evaluate the safety and tolerability of mevrometostat when administered as a tablet formulation to healthy participants.
Measured: Time the participant provides informed consent through and including follow-up contact occurring 28-35 calendar days after the lasts administration of the study intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study start28 Apr 2025 (estimated)
- Primary completion8 Sep 2025 (estimated)
- Study completion9 Sep 2025 (estimated)
Why it stopped: sponsor decision
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
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 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
- NCT06661694
- Sponsor's protocol ID
- C2321006
- Other IDs
- 2024-516907-18-00
- Status last verified
- Nov 2024
- First submitted
- 24 Oct 2024
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- 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 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE 1, RANDOMIZED, OPEN-LABEL, 4-PERIOD, CROSSOVER, SINGLE-DOSE STUDY IN HEALTHY PARTICIPANTS TO ESTIMATE THE EFFECT OF TABLET FORMULATION ON THE RELATIVE BIOAVAILABILITY OF MEVROMETOSTAT (PF-06821497)
- ClinicalTrials.gov ID
- NCT06661694
- Acronym / sponsor ID
- C2321006
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: sponsor decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 28 Apr 2025 (estimated)
- Primary completion
- 8 Sep 2025 (estimated)
- Study completion
- 9 Sep 2025 (estimated)
- First posted
- 28 Oct 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 the study is to compare the amount of mevrometostat available from four different tablet formulations, taken with food, in healthy adult participants.
This study is seeking male or female participants who:
- are 18 years or older
- are healthy as decided by medical tests.
- have a Body mass index (BMI) of 16 to 32 kilogram per meter squared
- a total body weight of more than 50 kilograms (110 pounds).
All participants will take part in 4 study periods to receive 4 different treatments, which are assigned in a random order. There will also be a 5-day gap between each study period. This is done so that the medicine is passed out of the body before the start of the next period.
Each treatment consists of a single dose of mevrometostat (PF-06821497), and the treatments differ only by tablet formulation.
How the medicine is processed in the body will be studied after giving the medicines to the participants. This will be done by collecting blood samples after giving each of these tablets. The results will be used to see the effect of tablet formulation on the amount of mevrometostat (PF-06821497) available in the blood of the participants.
Participants will be in the study for about 12 weeks.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Drug: Treatment A, Drug: Treatment B, Drug: Treatment C, Drug: Treatment DParticipants will receive a single 875 mg dose of Treatment A on Day 1 of Period 1, followed by a single 875 mg dose of Treatment B on Day 1 of Period 2, followed by a single 875 mg dose of Treatment C on Day 1 of Period 3, followed by a single 875 mg dose of Treatment D on Day 1 of Period 4. |
| Sequence 2 | Experimental | Drug: Treatment A, Drug: Treatment B, Drug: Treatment C, Drug: Treatment DParticipants will receive a single 875 mg dose of Treatment B on Day 1 of Period 1, followed by a single 875 mg dose of Treatment D on Day 1 of Period 2, followed by a single 875 mg dose of Treatment A on Day 1 of Period 3, followed by a single 875 mg dose of Treatment C on Day 1 of Period 4. |
| Sequence 3 | Experimental | Drug: Treatment A, Drug: Treatment B, Drug: Treatment C, Drug: Treatment DParticipants will receive a single 875 mg dose of Treatment C on Day 1 of Period 1, followed by a single 875 mg dose of Treatment A on Day 1 of Period 2, followed by a single 875 mg dose of Treatment D on Day 1 of Period 3, followed by a single 875 mg dose of Treatment B on Day 1 of Period 4. |
| Sequence 4 | Experimental | Drug: Treatment A, Drug: Treatment B, Drug: Treatment C, Drug: Treatment DParticipants will receive a single 875 mg dose of Treatment D on Day 1 of Period 1, followed by a single 875 mg dose of Treatment C on Day 1 of Period 2, followed by a single 875 mg dose of Treatment B on Day 1 of Period 3, followed by a single 875 mg dose of Treatment A on Day 1 of Period 4. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants ≥18 years of age, inclusive, at screening.
- Male and female participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs and 12-lead ECGs.
- BMI of 16-32 kg/m2; and a total body weight >50 kg (110 lb)
- Evidence of a personally signed and dated ICD indicating that the participant has been informed of all pertinent aspects of the study.
- Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
Key exclusion criteria (5 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) or prior allergic reaction to any component of mevrometostat.
- 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.
- Previous administration with an investigational product (drug or vaccine) within 30 days (or as determined by the local requirement) or 5 halflives 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 participation in this study.
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 |
|---|---|---|
| Treatment AAlso: PF-06821497Single 875 mg dose of mevrometostat standard tablet formulation | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4 |
| Treatment BAlso: PF-06821497Single 875 mg dose of mevrometostat alternative tablet formulation | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4 |
| Treatment CAlso: PF-06821497Single 875 mg dose of mevrometostat alternative tablet formulation | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4 |
| Treatment DAlso: PF-06821497Single 875 mg dose of mevrometostat alternative tablet formulation | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4 |
Primary outcome
Maximum Observed Plasma Concentration (Cmax) of Mevrometostat (Formulation 1)
Time frame: Period 1-4: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hour(s) post-dose
To estimate the bioavailability of a single 875 mg dose of mevrometostat (Formulation 2) relative to a single 875 mg dose of mevrometostat (Formulation 1) under fed conditions in healthy adult participants.
Maximum Observed Plasma Concentration (Cmax) of Mevrometostat (Formulation 2)
Time frame: Period 1-4: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hour(s) post-dose
To estimate the bioavailability of a single 875 mg dose of mevrometostat (Formulation 2) relative to a single 875 mg dose of mevrometostat (Formulation 1) under fed conditions in healthy adult participants.
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of Mevrometostat (Formulation 1)
Time frame: Period 1-4: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hour(s) post-dose
To estimate the bioavailability of a single 875 mg dose of mevrometostat (Formulation 2) relative to a single 875 mg dose of mevrometostat (Formulation 1) under fed conditions in healthy adult participants.
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of Mevrometostat (Formulation 2)
Time frame: Period 1-4: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hour(s) post-dose
To estimate the bioavailability of a single 875 mg dose of mevrometostat (Formulation 2) relative to a single 875 mg dose of mevrometostat (Formulation 1) under fed conditions in healthy adult participants.
8 secondary outcomes
Maximum Observed Plasma Concentration (Cmax) of Mevrometostat (Formulation 3)
Time frame: Period 1-4: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hour(s) post-dose
Maximum Observed Plasma Concentration (Cmax) of Mevrometostat (Formulation 4)
Time frame: Period 1-4: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hour(s) post-dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of Mevrometostat (Formulation 3)
Time frame: Period 1-4: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hour(s) post-dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of Mevrometostat (Formulation 4)
Time frame: Period 1-4: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hour(s) post-dose
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Time the participant provides informed consent through and including follow-up contact occurring 28-35 calendar days after the lasts administration of the study intervention.
Number of Participants With Clinical Laboratory Abnormalities
Time frame: Time the participant provides informed consent through and including follow-up contact occurring 28-35 calendar days after the lasts administration of the study intervention.
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Time frame: Time the participant provides informed consent through and including follow-up contact occurring 28-35 calendar days after the lasts administration of the study intervention.
Number of Participants With Electrocardiogram (ECG) Abnormalities
Time frame: Time the participant provides informed consent through and including follow-up contact occurring 28-35 calendar days after the lasts administration of the study intervention.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
- 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.
Related trials for Healthy
Not yet recruitingPhase 1
Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium Contrast
Healthy Volunteers
RecruitingObservational study
Survey to Determine Incarcerated Persons' Views on Surrogate Decision Making
Healthy Volunteers
Active, not recruitingPhase 1
A Study to Learn How Different Amounts of the Study Medicine Called PF-07985631 Are Tolerated and Act in the Body of Healthy Adults
Healthy
Not yet recruitingObservational study
Collection and Distribution of Blood Components From Healthy Donors for In Vitro Research Use
Blood Donors, Apheresis
Recruiting
Metabolic Impact of VLCPUFA-Rich Fish Oil: A Clinical Study on Omega-3 Index Enhancement in Healthy Individuals
Fatty Acids, Omega-3, Fish Oils
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 Treatment A, Treatment B and Treatment C in people with 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 5 inclusion and 5 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: withdrawn, as of the sponsor's last update on 24 Apr 2025. 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. 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 was withdrawn before enrolling participants, so there are no results.
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?
Maximum Observed Plasma Concentration (Cmax) of Mevrometostat (Formulation 1) (time frame: Period 1-4: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hour(s) post-dose). The study lists 4 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 24 Apr 2025.