A Study to Learn How Different Tablets of the Study Medicine Mevrometostat Are Taken up Into the Blood in Healthy Adults

NCT06661694 | Withdrawn Phase 1

• 2 other identifiers: C23210062024-516907-18-00
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.
• 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

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  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)

  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)

  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)

  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)

  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 the participant provides informed consent through and including follow-up contact occurring 28-35 calendar days after the lasts administration of the study intervention.

Study Arms (4)

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.

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.

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.

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.

Drug: Treatment A; Drug: Treatment B; Drug: Treatment C; Drug: Treatment D

Interventions

Treatment A DRUG

Single 875 mg dose of mevrometostat standard tablet formulation

Also known as: PF-06821497

Sequence 1; Sequence 2; Sequence 3; Sequence 4

Treatment B DRUG

Single 875 mg dose of mevrometostat alternative tablet formulation

Also known as: PF-06821497

Sequence 1; Sequence 2; Sequence 3; Sequence 4

Treatment C DRUG

Single 875 mg dose of mevrometostat alternative tablet formulation

Also known as: PF-06821497

Sequence 1; Sequence 2; Sequence 3; Sequence 4

Treatment D DRUG

Single 875 mg dose of mevrometostat alternative tablet formulation

Also known as: PF-06821497

Sequence 1; Sequence 2; Sequence 3; Sequence 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Clinical Research Unit - Brussels

Brussels, Bruxelles-capitale, Région de, B-1070, Belgium

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

PF06821497

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2024
• First Posted: October 28, 2024
• Study Start: April 28, 2025
• Primary Completion: September 8, 2025
• Study Completion: September 9, 2025
• Last Updated: April 24, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)