STUDY OF PF-07321332 IN HEALTHY PARTICIPANTS

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Drug: PF-07321332 Dose 1; Drug: PF-07321332 Dose 2; Drug: PF-07321332 Dose 4; Drug: PF-07321332 Dose 4 or Placebo (Fed); Drug: PF-07321332 Dose 5; Drug: PF-07321332 Dose 3

Study type: Interventional

Funder types: Industry

Identifiers

NCT04756531

C4671001

2020-006073-30 (EudraCT Number)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 70 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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70 participants in 6 patient groups

PF-07321332 Dose 1

Experimental group

Description:

Dose level 1 of PF-07321332

Treatment:

Drug: PF-07321332 Dose 1

PF-07321332 Dose 2

Experimental group

Description:

Dose level 2 of PF-07321332

Treatment:

Drug: PF-07321332 Dose 2

PF-07321332 Dose 3

Experimental group

Description:

Dose level 3 of PF-07321332

Treatment:

Drug: PF-07321332 Dose 3

PF-07321332 Dose 4

Experimental group

Description:

Dose level 4 of PF-07321332

Treatment:

Drug: PF-07321332 Dose 4

PF-07321332 Dose 5

Experimental group

Description:

Dose level 5 of PF-07321332

Treatment:

Drug: PF-07321332 Dose 5

PF-07321332 Dose 4 (Fed)

Experimental group

Description:

Dose level 4 of PF-07321332 with high fat meal

Treatment:

Drug: PF-07321332 Dose 4 or Placebo (Fed)