Clinical trial NCT06659250: A Study to Learn How Different Amounts and Forms of the Study Medicine Called PF-06414300 Act in Healthy Adults
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy Participants
Keywords: Healthy adults
First in human
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2024-10-26
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Adverse Events (AE) observed after single or multiple doses
timeFrame: Day 1 up to Day 28 (Part A)/Day 1 up to Day 38 (Part B)
measure: Number of Serious AE observed after single or multiple doses
timeFrame: Day 1 up to Day 28 (Part A)/Day 1 up to Day 38 (Part B)
measure: Number of participants with abnormal vital sign changes following single or multiple ascending doses
timeFrame: Day 1 up to Day 28 (Part A)/Day 1 up to Day 38 (Part B)
measure: Number of Participants with Electrocardiogram (ECG) Abnormalities including QT and QTcF interval following single or multiple ascending dose
timeFrame: Day 1 up to Day 28 (Part A)/Day 1 up to Day 38 (Part B)
measure: Number of participants with clinically significant laboratory values
timeFrame: Day 1 up to Day 28 (Part A)/Day 1 up to Day 38 (Part B)
Secondary outcomes:
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) Part A
timeFrame: Day 1 up to Day 4 (Part A)
measure: Maximum Observed Plasma Concentration (Cmax) Part A
timeFrame: Day 1 up to Day 4 (Part A)
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) Part A
timeFrame: Day 1 up to Day 4 (Part A)
measure: AUClast Part B
timeFrame: Day 1 up to Day 10 (Part B)
measure: Cmax Part B
timeFrame: Day 1 up to Day 10 (Part B)
measure: Tmax Part B
timeFrame: Day 1 up to Day 10 (Part B)
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer Clinical Research Unit - New Haven
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: