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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-27

Study Completion Date

2025-08-22

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study to Evaluate Safety, Toleration and Time Course of Plasma Concentration of Multiple Oral Doses of PF-06273340 in Healthy Subjects of Two AgeGroups, Aged 18-55 Years (Group 1) and Aged 56-75 Years (Group 2)

NCT01934738

Healthy

COMPLETED PHASE1

Evaluation Of Safety, Tolerability And Pharmacokinetics Of Single And Multiple Doses Of Compound PF-06823859

NCT02766621

Healthy

COMPLETED PHASE1

A Study To Evaluate the Safety, Tolerability, And Pharmacokinetics Of PF-06266047 In Healthy Adult Subjects

NCT02539550

Healthy Volunteers

COMPLETED PHASE1

A Study to Learn How Different Amounts of the Study Medicine Called PF-07314470 Are Tolerated and Act in the Body in Healthy Adults

NCT06821750

Healthy

TERMINATED PHASE1

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PF-06842874 in Healthy Participants

NCT04124653

Healthy Participants

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Participants

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

PF-06414300

Participants will receive single or multiple ascending oral doses of PF-06414300

Group Type EXPERIMENTAL

PF-06414300

Intervention Type DRUG

Participants will receive oral ascending doses.

Placebo

Participants will receive matching placebo.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Participants will receive matching placebo.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PF-06414300

Participants will receive oral ascending doses.

Intervention Type DRUG

Placebo

Participants will receive matching placebo.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion 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).

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes