A Study to Learn About the Study Medicine PF-07321332 and Ritonavir in Adult Healthy Chinese Participants.

NCT05339334 | Completed Phase 1 Results

• 1 other identifier: C4671016
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this Phase 1 clinical trial is to help us understand how the drug is changed and eliminated from your body after you take it, the safety, and the the extent to which dise effects can be tolerated of PF-07321332 when PF-07321332 and ritonavir are given to healthy adult Chinese participants.

Conditions

Healthy Participants

Keywords

severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2); coronavirus disease 2019 (COVID-19)

Outcome Measures

Primary Outcomes (18)

• PF-07321332 Maximum Observed Plasma Concentration (Cmax) on Day 1

  Cmax is maximum plasma concentration .

  Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)

• PF-07321332 Maximum Observed Plasma Concentration (Cmax) on Day 10

  Cmax is maximum plasma concentration

  Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours)

• PF-07321332 Time for Maximum Observed Plasma Concentration (Tmax) on Day 1

  Tmax is the time for maximum plasma concentration

  Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)

• PF-07321332 Time for Maximum Observed Plasma Concentration (Tmax) on Day 10

  Tmax is the time for maximum plasma concentration

  Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours)

• PF-07321332 Area Under the Plasma Concentration-time Profile From Time Zero to Time Point on 12 Hours (AUC12) on Day 1

  Area under the plasma concentration-time profile from time Zero to time point on 12 hours

  Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)

• PF-07321332 Area Under the Plasma Concentration-time Profile From Time Zero to Time Tau (Where Tau=12 Hours) (AUCtau) on Day 10

  Area under the plasma concentration-time profile from time 0 to the time of the end of the dosing interval (tau), where tau=12 hours.

  Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours)

• PF-07321332 Average Plasma Concentration Over the Dosing Interval (Cav) on Day 10

  This was determined by AUCtau/tau.

  Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)

• PF-07321332 Accumulation Ratio for AUCtau (Rac) on Day 10

  Accumulation ratio for AUCtau following multiple dosing was calculated as AUCtau on Day 10 divided by AUC12 on Day 1.

  Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours); Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)

• PF-07321332 Accumulation Ratio for Cmax (Rac, Cmax) on Day 10

  Observed accumulation ratio for Cmax was calculated as Cmax on Day 10 divided by Cmax on Day 1.

  Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours); Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours)

• PF-07321332 Peak-to-trough Ratio (PTR) on Day 10

  This was determined by Day 10 Cmax/Day 10 Ctrough.

  Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)

• PF-07321332 Apparent Clearance (CL/F) on Day 10

  Apparent oral clearance. This was determined by Dose/AUCtau.

  Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)

• PF-07321332 Apparent Volume of Distribution (Vz/F) on Day 10

  Apparent oral volume of distribution.

  Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)

• PF-07321332 Terminal Elimination Half-life (t½) on Day 10

  Terminal half-life. This was determined by Loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.

  Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 and 48 hours)

• PF-07321332 Area Under the Plasma Concentration-time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) on Day 10

  Area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration (Clast)

  Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 and 48 hours)

• PF-07321332 Trough Concentration (Ctrough) on Day 5

  Concentration at pre-dose on Day 5. Observed directly from data.

  Day 5 (pre-dose)

• PF-07321332 Trough Concentration (Ctrough) on Day 8

  Concentration at pre-dose on Day 8. Observed directly from data.

  Day 8 (pre-dose)

• PF-07321332 Trough Concentration (Ctrough) on Day 10 (Pre-dose)

  Concentration at pre-dose on Day 10. Observed directly from data.

  Day 10 (pre-dose)

• PF-07321332 Trough Concentration (Ctrough) on Day 10 (12 Hours After Last Dose)

  Concentration at 12 hour time on Day 10. Observed directly from data.

  Day 10 (12 hours after last dose)

Secondary Outcomes (19)

• Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

  From baseline up to Day 42

• Number of Participants With Vital Signs Data Meeting Pre-Specified Categorization Criteria

  Day 1 (pre-dose, within 1-2 hours after morning dose), Day 10 (pre-dose, within 1-2 hours after morning dose)

• Number of Participants With Laboratory Abnormalities

  Day-1, Day 2, Day 5, Day 8, Day 10, Day 12.

• Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Categorization Criteria

  Day 1 (pre-dose, within 1-2 hours after morning dose), Day 10 (pre-dose, within 1-2 hours after morning dose)

• Ritonavir Maximum Observed Plasma Concentration (Cmax) on Day 1

  Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)

Study Arms (1)

PF-07321332/ritonavir

EXPERIMENTAL

PF-07321332/ritonavir will be given by mouth two times a day for 10 days to adult Chinese healthy volunteers

Drug: PF-07321332/ritonavir

Interventions

PF-07321332/ritonavir DRUG

PF-07321332/ritonavir will be given by mouth two times a day for 10 days

PF-07321332/ritonavir

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy Chinese participants
• No clinical relevant abnormalities
• Body mass index (BMI):17.5-28

You may not qualify if:

• Any clinical significant illness
• History of alcohol abuse
• Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days prior the first study dose
• Abnormal clinical lab tests: aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, estimated glomerular filtration rate (eGFR)
• Abnormal vital signs, such 12-electrocardiogram (ECG), blood pressure and pulse rate
• Blood donation within 60 days
• History of human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), hepatitis C antibody (HCVAb)
• Other medical or psychiatric may inappropriate for the study

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Huashan Hospital,Fudan University

Shanghai, Shanghai Municipality, 201107, China

Location

Related Links

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

MeSH Terms

Conditions

COVID-19

Interventions

nirmatrelvir and ritonavir drug combination

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2022
• First Posted: April 21, 2022
• Study Start: March 10, 2022
• Primary Completion: April 21, 2022
• Study Completion: April 21, 2022
• Last Updated: October 8, 2024
• Results First Posted: October 8, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)