COMPLETED

A Study to Learn How Different Amounts and Forms of the Study Medicine Called PF-06414300 Act in Healthy Adults

Conditions

Healthy Participants Healthy adults First in human

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to learn about how different amounts of study medicine called PF-06414300 acts and is changed and eliminated from the body of healthy adult participants. The amount of PF-06414300 in blood after the medicine is taken by mouth will also be measured. The study is seeking for participants who: * Are male or female of 18 to 65 years of age. * Are in good health condition. * Have body mass index of 16 to 32 kilograms per squared meters; and a total body weight of more than 50 kilograms (110 pounds). All participants in this study will receive either PF-06414300 or placebo (dummy pill) by chance. The study will have 2 parts; in the first part of the study (Part A), each participant will receive a total of 4 doses of PF-06414300 or placebo with at least 10 to 14 days between each dose. After each dose, participants will stay in study clinic for 4 to 5 days. In the second part of the study (Part B), each participant will receive a total of 10 doses of PF-06414300 or placebo and participants will stay in study clinic for 14 days. An optional Japanese cohort may be done later. The planned duration of participation from screening to follow up in Part A and B of this study is up to 12 to 14 weeks and 10 to 12 weeks, respectively. Participants will also have their blood collected by the study doctors several times.

Official Title

A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR OPEN, PLACEBO CONTROLLED STUDY TO ASSESS SAFETY, TOLERABILITY AND PHARMACOKINETICS OF SINGLE AND MULTIPLE ASCENDING ORAL DOSES OF PF-06414300 ADMINISTERED AS IMMEDIATE AND MODIFIED RELEASE FORMULATIONS IN HEALTHY ADULT PARTICIPANTS

Quick Facts

Study Start:2024-09-27

Study Completion:2025-08-22

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06659250

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Body mass Index (BMI) of 16-32 kg/m2; and a total body weight \>50 kg (110 lb). * Male and female participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs assessments, 12-lead ECGs and laboratory tests. * Additional criterion for participants to be enrolled in the Japanese cohort only: Participants who have 4 Japanese biologic grandparents born in Japan; body weight \>45 kg (99 lb).	* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular (including hypertension irrespective of age), hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing). * 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. * Recent history of abnormal bowel movements, such as diarrhea, loose stools, or constipation, within 1 week prior to first dose. * Previous administration of an investigational product (drug or vaccine) within 30 days 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 participation in this study.

Inclusion Criteria

Exclusion Criteria

* Body mass Index (BMI) of 16-32 kg/m2; and a total body weight \>50 kg (110 lb).
* Male and female participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs assessments, 12-lead ECGs and laboratory tests.
* Additional criterion for participants to be enrolled in the Japanese cohort only: Participants who have 4 Japanese biologic grandparents born in Japan; body weight \>45 kg (99 lb).

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular (including hypertension irrespective of age), hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
* 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.
* Recent history of abnormal bowel movements, such as diarrhea, loose stools, or constipation, within 1 week prior to first dose.
* Previous administration of an investigational product (drug or vaccine) within 30 days 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 participation in this study.

Contacts and Locations

Principal Investigator

Pfizer CT.gov Call Center

STUDY_DIRECTOR

Pfizer

Study Locations (Sites)

Pfizer Clinical Research Unit - New Haven

New Haven, Connecticut, 06511

United States

Collaborators and Investigators

Sponsor: Pfizer

Pfizer CT.gov Call Center, STUDY_DIRECTOR, Pfizer

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-27

Study Completion Date2025-08-22

Study Record Updates

Study Start Date2024-09-27

Study Completion Date2025-08-22

Terms related to this study

Keywords Provided by Researchers

Healthy adults
First in human

Additional Relevant MeSH Terms

Healthy Participants