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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Drug: Placebo; Drug: PF-06414300

Study type: Interventional

Funder types: Industry

Identifiers

NCT06659250

NCT06659250 (Registry Identifier)

C5651001

Details and patient eligibility

About

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.

Enrollment: 63 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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63 participants in 2 patient groups, including a placebo group

PF-06414300

Experimental group

Description:

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

Treatment:

Drug: PF-06414300

Placebo

Placebo Comparator group

Description:

Participants will receive matching placebo.

Treatment:

Drug: Placebo