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A Study to Learn Safety and Blood Levels of PF-07817883 in Healthy People

NCT ID: NCT05580003

Last Updated: 2024-11-21

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-17

Study Completion Date

2023-09-15

Brief Summary

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The purpose of this clinical trial is to learn if the study medicine (called PF-07817883) is safe and how it goes in and out of the body in healthy people. PF-07817883 is for the potential treatment of COVID-19. Participants will take PF-07817883 by mouth up to 2 times a day. This study may also evaluate how much PF-07817883 gets into the body when taken as pill. We may study if people's diets can affect this study medicine. We may also examine how PF-07817883 is processed and removed by the human body. Finally, we may look into if PF-07817883 has potential to interact with midazolam.

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Detailed Description

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Combined 6-part study. Part-1: Single Ascending dose Part-2: Multiple Ascending Dose Part-3: Relative bioavailability and food effect Part-4: Metabolism and Excretion Part-5: Drug-drug interaction with midazolam Part-6: Supratherapeutic exposure Part-1,2 and 6 are double blind, sponsor open and Part-3,4 and 5 are open label study.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

PART-1 and -2 are a randomized, double-blind, sponsor-open, placebo-controlled trial to evaluate safety, tolerability and PK of single and multiple escalating oral doses of PF 07817883 in healthy adult participants, respectively. PART-1 is crossover while PART-2 is parallel cohort study design. PART-2 of the study may also evaluate the safety, tolerability and PK in Japanese and Chinese participants. PART-3 is a randomized, open-label, cross-over, study to evaluate relative bioavailability and food effect of up to 2 new PF 07817883 oral formulations. PART-4 is an open label, non-randomized, single period cohort to evaluate the metabolism and excretion of PF 07817883. PART-5 is an open-label, randomized, cross-over cohort to evaluate the effect of steady state PF-07817883 on PK of midazolam in healthy participants. PART-6 is a sponsor-open, randomized, 3-treatment, 3-period, cross over study to evaluate safety, tolerability, and PK of PF 07817883 at supratherapeutic exposure.
Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators
PART-1, 2 and 6 are double-blind, sponsor-open while PART-3, 4 and 5 are open label

Study Groups

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PF-07817883 Dose 1 in PART-1

Group Type EXPERIMENTAL

PF-07817883

Intervention Type DRUG

Oral suspension or solid oral formulation(s)

PF-07817883 Dose 2 in PART-1

Group Type EXPERIMENTAL

PF-07817883

Intervention Type DRUG

Oral suspension or solid oral formulation(s)

PF-07817883 Dose 3 in PART-1

Group Type EXPERIMENTAL

PF-07817883

Intervention Type DRUG

Oral suspension or solid oral formulation(s)

PF-07817883 Dose 4 in PART-1

Group Type EXPERIMENTAL

PF-07817883

Intervention Type DRUG

Oral suspension or solid oral formulation(s)

PF-07817883 Dose 5 in PART-1

Optional dose levels

Group Type EXPERIMENTAL

PF-07817883

Intervention Type DRUG

Oral suspension or solid oral formulation(s)

PF-07817883 Dose 6 in PART-1

Optional dose levels

Group Type EXPERIMENTAL

PF-07817883

Intervention Type DRUG

Oral suspension or solid oral formulation(s)

Placebo in PART-1

A single dose of placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo suspension

PF-07817883 DR1 in PART-2

DR=Dosing regimen; twice a day

Group Type EXPERIMENTAL

PF-07817883

Intervention Type DRUG

Oral suspension or solid oral formulation(s)

PF-07817883 DR2 in PART-2

Group Type EXPERIMENTAL

PF-07817883

Intervention Type DRUG

Oral suspension or solid oral formulation(s)

PF-07817883 DR3 in PART-2

Optional dosing regimen

Group Type EXPERIMENTAL

PF-07817883

Intervention Type DRUG

Oral suspension or solid oral formulation(s)

PF-07817883 DR4 in PART-2

Optional dosing regimen

Group Type EXPERIMENTAL

PF-07817883

Intervention Type DRUG

Oral suspension or solid oral formulation(s)

PF-07817883 in Japanese in PART-2

Optional dosing regimen to be studied in Japanese population

Group Type EXPERIMENTAL

PF-07817883

Intervention Type DRUG

Oral suspension or solid oral formulation(s)

PF-07817883 in Chinese in PART-2

Optional dosing regimen to be studied in Chinese population

Group Type EXPERIMENTAL

PF-07817883

Intervention Type DRUG

Oral suspension or solid oral formulation(s)

Placebo in PART-2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo suspension

PF-07817883 Suspension Fasted in PART-3

PART-3 is optional

Group Type EXPERIMENTAL

PF-07817883

Intervention Type DRUG

Oral suspension or solid oral formulation(s)

PF-07817883 FORM-1 Fasted in PART-3

First solid oral formulation (FORM1)

Group Type EXPERIMENTAL

PF-07817883

Intervention Type DRUG

Oral suspension or solid oral formulation(s)

PF-07817883 FORM-2 Fasted in PART-3

Second solid oral formulations (FORM-2) is optional

Group Type EXPERIMENTAL

PF-07817883

Intervention Type DRUG

Oral suspension or solid oral formulation(s)

PF-07817883 FORM-1 Fed in PART-3

Group Type EXPERIMENTAL

PF-07817883

Intervention Type DRUG

Oral suspension or solid oral formulation(s)

PF-07817883 FORM-2 Fed in PART-3

Group Type EXPERIMENTAL

PF-07817883

Intervention Type DRUG

Oral suspension or solid oral formulation(s)

PF-07817883 in PART-4

PART-4 is optional

Group Type EXPERIMENTAL

PF-07817883

Intervention Type DRUG

Oral suspension or solid oral formulation(s)

Midazolam 5 mg in PART-5

Single dose of 5 mg alone

Group Type EXPERIMENTAL

Midazolam

Intervention Type DRUG

midazolam oral solution

Midazolam 5 mg with PF-07817883 in PART-5

Single dose of 5 mg on Day 10 with multiple doses (twice a day) of PF-07817883

Group Type EXPERIMENTAL

PF-07817883

Intervention Type DRUG

Oral suspension or solid oral formulation(s)

Midazolam

Intervention Type DRUG

midazolam oral solution

PF-07817883 in PART-6

A single dose at supratherapeutic exposure administered as divided doses (1h apart)

Group Type EXPERIMENTAL

PF-07817883

Intervention Type DRUG

Oral suspension or solid oral formulation(s)

Placebo in PART-6

A single dose of placebo administered as divided doses (1h apart)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo suspension

Moxifloxacin 400 mg in PART-6 (open label)

Moxifloxacin 400 mg at 0h followed by placebo at 1h

Group Type ACTIVE_COMPARATOR

Placebo

Intervention Type DRUG

Placebo suspension

Moxifloxacin

Intervention Type DRUG

Moxifloxacin 400 mg tablet

Interventions

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PF-07817883

Oral suspension or solid oral formulation(s)

Intervention Type DRUG

Placebo

Placebo suspension

Intervention Type DRUG

Midazolam

midazolam oral solution

Intervention Type DRUG

Moxifloxacin

Moxifloxacin 400 mg tablet

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male or female subjects between ages of 18-60 years. Male only in part-4.
* Body Mass Index (BMI) of 17.5 to 30.5kg/m2; and a total body weight \>50kg (110lbs). A body weight of \>45 kg may be considered in selected cases.
* Japanese subjects who have four Japanese biologic grandparents born in Japan
* Chinese participants who were born in mainland China and both parents are of the Chinese descent.

Exclusion Criteria

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)
* Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy, intestinal resection).
* Positive test result for SARS-CoV-2 infection at the time of screening or Day-1.
* Have received COVID-19 vaccine within 7 days before screening or have received only one of the 2 required doses of COVID-19 vaccine
* Use of tobacco or nicotine containing products in excess of the equivalents of 5 cigarettes per day or 2 chews of tobacco per day
* Use of prescription or nonprescription drugs and dietary and herbal supplements within 28 days or 5 half lives (whichever is longer) prior to the first dose of study intervention.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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New Haven Clinical Research Unit

New Haven, Connecticut, United States

Site Status

Pfizer Clinical Research Unit - Brussels

Brussels, Bruxelles-capitale, Région de, Belgium

Site Status

Countries

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United States Belgium

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://pmiform.com/clinical-trial-info-request?StudyID=C5091001

To obtain contact information for a study center near you, click here.

Other Identifiers

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2022-002871-12

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2022-002871-12

Identifier Type: REGISTRY

Identifier Source: secondary_id

C5091001

Identifier Type: -

Identifier Source: org_study_id

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