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STUDY OF PF-07321332 IN HEALTHY PARTICIPANTS

NCT ID: NCT04756531

Last Updated: 2024-10-15

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-11

Study Completion Date

2021-09-01

Brief Summary

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A Phase 1, double blind, sponsor open, single and multiple ascending dose study to evaluate safety, tolerability and pharmacokinetics of PF-07321332 in healthy participants.

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Detailed Description

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Combined 5-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: Supra-therapeutic Exposure Part-1,2 and 5 are double blind, sponsor open and Part-3 and 4 are open label study.

Conditions

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Healthy Participants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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PF-07321332 Dose 1

Dose level 1 of PF-07321332

Group Type EXPERIMENTAL

PF-07321332 Dose 1

Intervention Type DRUG

PF-07321332 Dose 1 or Placebo

PF-07321332 Dose 2

Dose level 2 of PF-07321332

Group Type EXPERIMENTAL

PF-07321332 Dose 2

Intervention Type DRUG

PF-07321332 Dose 2 or Placebo

PF-07321332 Dose 3

Dose level 3 of PF-07321332

Group Type EXPERIMENTAL

PF-07321332 Dose 3

Intervention Type DRUG

PF-07321332 Dose 3 or Placebo

PF-07321332 Dose 4

Dose level 4 of PF-07321332

Group Type EXPERIMENTAL

PF-07321332 Dose 4

Intervention Type DRUG

PF-07321332 Dose 4 or Placebo

PF-07321332 Dose 5

Dose level 5 of PF-07321332

Group Type EXPERIMENTAL

PF-07321332 Dose 5

Intervention Type DRUG

PF-07321332 Dose 5 or Placebo

PF-07321332 Dose 4 (Fed)

Dose level 4 of PF-07321332 with high fat meal

Group Type EXPERIMENTAL

PF-07321332 Dose 4 or Placebo (Fed)

Intervention Type DRUG

PF-07321332 Dose 5 or Placebo with high fat meal

Interventions

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PF-07321332 Dose 1

PF-07321332 Dose 1 or Placebo

Intervention Type DRUG

PF-07321332 Dose 2

PF-07321332 Dose 2 or Placebo

Intervention Type DRUG

PF-07321332 Dose 3

PF-07321332 Dose 3 or Placebo

Intervention Type DRUG

PF-07321332 Dose 4

PF-07321332 Dose 4 or Placebo

Intervention Type DRUG

PF-07321332 Dose 5

PF-07321332 Dose 5 or Placebo

Intervention Type DRUG

PF-07321332 Dose 4 or Placebo (Fed)

PF-07321332 Dose 5 or Placebo with high fat meal

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)
* Japanese subjects who have four Japanese biologic grandparents born in Japan

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
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

References

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Singh RSP, Toussi SS, Hackman F, Chan PL, Rao R, Allen R, Van Eyck L, Pawlak S, Kadar EP, Clark F, Shi H, Anderson AS, Binks M, Menon S, Nucci G, Bergman A. Innovative Randomized Phase I Study and Dosing Regimen Selection to Accelerate and Inform Pivotal COVID-19 Trial of Nirmatrelvir. Clin Pharmacol Ther. 2022 Jul;112(1):101-111. doi: 10.1002/cpt.2603. Epub 2022 May 4.

Reference Type DERIVED
PMID: 35388471 (View on PubMed)

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=C4671001

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

Other Identifiers

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2020-006073-30

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

C4671001

Identifier Type: -

Identifier Source: org_study_id

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