A Study of Single Ascending Doses of PF-07258669 in Healthy Adult Participants

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-16

Study Completion Date

2021-08-25

Brief Summary

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This study will be the first time PF-07258669 is administered to humans. The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of PF-07258669 following administration of single oral doses to healthy adult participants.

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Detailed Description

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Conditions

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Healthy Participants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Cohort 1

Single dose administration of PF-07258669 and placebo; Within a cohort, participants will receive 3 doses of PF-07258669 and 1 dose of placebo.

Group Type EXPERIMENTAL

PF-07258669

Intervention Type DRUG

PF-07258669 will be prepared as an oral solution and/or suspension given in escalating single doses to be determined

Placebo

Intervention Type DRUG

Matching placebo will be prepared as an oral solution and/or suspension given in each cohort

Cohort 2

Single dose administration of PF-07258669 and placebo; Within a cohort, participants will receive 3 doses of PF-07258669 and 1 dose of placebo.

Group Type EXPERIMENTAL

PF-07258669

Intervention Type DRUG

PF-07258669 will be prepared as an oral solution and/or suspension given in escalating single doses to be determined

Placebo

Intervention Type DRUG

Matching placebo will be prepared as an oral solution and/or suspension given in each cohort

Cohort 3

Single dose administration of PF-07258669 and placebo; Within a cohort, participants will receive 3 doses of PF-07258669 and 1 dose of placebo.

Group Type EXPERIMENTAL

PF-07258669

Intervention Type DRUG

PF-07258669 will be prepared as an oral solution and/or suspension given in escalating single doses to be determined

Placebo

Intervention Type DRUG

Matching placebo will be prepared as an oral solution and/or suspension given in each cohort

Interventions

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PF-07258669

PF-07258669 will be prepared as an oral solution and/or suspension given in escalating single doses to be determined

Intervention Type DRUG

Placebo

Matching placebo will be prepared as an oral solution and/or suspension given in each cohort

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Female participants of non-child bearing potential and male participants and who are overtly healthy as determined by medical evaluation including medical history, physical examination, neurological examination, laboratory tests, and cardiac monitoring.
* Participants who are willing to avoid direct sunlight exposure or any high intensity ultraviolet light exposure from admission to the follow-up contact and to apply sunscreen/lotion with a high sun protection factor, as appropriate.
* BMI of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lb).

Exclusion Criteria

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing), as well as presence of lipid panel abnormalities (eg, hypercholesterolemia, hypertriglyceridemia).
* Evidence of history of orthostatic hypotension or symptomatic bradycardia.
* Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study intervention.
* Previous administration with an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer).
* Current findings or documented past history of blood pressure values \<90 mmHg systolic or \<50 mmHg diastolic.
* Any lipid panel parameter (ie, total cholesterol, triglycerides, HDL, and/or LDL) ≥1.25× ULN.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes