CompletedNCT06659250Updated Oct 1, 2025

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

A Phase 1 interventional study of PF-06414300 and Placebo in Healthy Participants, sponsored by Pfizer. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-10-01.

Sponsored by Pfizer · Phase 1, Interventional, and Basic science

From the registry’s dates

Primary completion was Aug 2025, 1 year 1 month ago, and no results have been posted to the registry.

Phase: Phase 1
Study type: Interventional
Enrollment: 63
Allocation: Randomized
Ages: 18 Years to 65 Years
Sex: All

Study summary

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.

Conditions studied

Healthy Participants

Keywords

Healthy adults
First in human

In context

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

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

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.

Study design

Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomized
Intervention model: Sequential assignment
Masking: Double (Participant, Investigator)
Enrollment: 63 participants (actual)

Study arms

Experimental
PF-06414300
Participants will receive single or multiple ascending oral doses of PF-06414300
Drug: PF-06414300
Placebo comparator
Placebo
Participants will receive matching placebo.
Drug: Placebo

Interventions

DrugPF-06414300
Participants will receive oral ascending doses.
DrugPlacebo
Participants will receive matching placebo.

What researchers measure

Primary outcomes

Number of Adverse Events (AE) observed after single or multiple doses
Time frame: Day 1 up to Day 28 (Part A)/Day 1 up to Day 38 (Part B)
Number of Serious AE observed after single or multiple doses
Time frame: Day 1 up to Day 28 (Part A)/Day 1 up to Day 38 (Part B)
Number of participants with abnormal vital sign changes following single or multiple ascending doses
Time frame: Day 1 up to Day 28 (Part A)/Day 1 up to Day 38 (Part B)
Number of Participants with Electrocardiogram (ECG) Abnormalities including QT and QTcF interval following single or multiple ascending dose
Time frame: Day 1 up to Day 28 (Part A)/Day 1 up to Day 38 (Part B)
Number of participants with clinically significant laboratory values
Time frame: Day 1 up to Day 28 (Part A)/Day 1 up to Day 38 (Part B)

Secondary outcomes

Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) Part A
Time frame: Day 1 up to Day 4 (Part A)
Maximum Observed Plasma Concentration (Cmax) Part A
Time frame: Day 1 up to Day 4 (Part A)
Time to Reach Maximum Observed Plasma Concentration (Tmax) Part A
Time frame: Day 1 up to Day 4 (Part A)
AUClast Part B
Time frame: Day 1 up to Day 10 (Part B)
Cmax Part B
Time frame: Day 1 up to Day 10 (Part B)
Tmax Part B
Time frame: Day 1 up to Day 10 (Part B)

Study locations

1 site

Pfizer Clinical Research Unit - New Haven
New Haven, Connecticut 06511, United States

References and documents

Individual participant data

Plan to share: 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.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 1, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT06659250
Lead sponsor: Pfizer
Responsible party: Sponsor
First posted: Oct 26, 2024
Start date: Sep 27, 2024
Primary completion: Aug 22, 2025
Completion: Aug 22, 2025
Last update: Oct 1, 2025

Study contacts

Pfizer CT.gov Call Center

study director · Pfizer

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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