Clinical trial NCT05339334: A Study to Learn About the Study Medicine PF-07321332 and Ritonavir in Adult Healthy Chinese Participants.
Official title: A Phase 1, Single Center, Open-label Study of PF-07321332 Administrated as Multiple Oral Doses in Healthy Chinese Participants.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Keywords: severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
coronavirus disease 2019 (COVID-19)
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2022-04-21
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: PF-07321332 Maximum Observed Plasma Concentration (Cmax) on Day 1
timeFrame: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)
measure: PF-07321332 Maximum Observed Plasma Concentration (Cmax) on Day 10
timeFrame: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours)
measure: PF-07321332 Time for Maximum Observed Plasma Concentration (Tmax) on Day 1
timeFrame: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)
measure: PF-07321332 Time for Maximum Observed Plasma Concentration (Tmax) on Day 10
timeFrame: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours)
measure: PF-07321332 Area Under the Plasma Concentration-time Profile From Time Zero to Time Point on 12 Hours (AUC12) on Day 1
timeFrame: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)
measure: PF-07321332 Area Under the Plasma Concentration-time Profile From Time Zero to Time Tau (Where Tau=12 Hours) (AUCtau) on Day 10
timeFrame: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours)
measure: PF-07321332 Average Plasma Concentration Over the Dosing Interval (Cav) on Day 10
timeFrame: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)
measure: PF-07321332 Accumulation Ratio for AUCtau (Rac) on Day 10
timeFrame: 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)
measure: PF-07321332 Accumulation Ratio for Cmax (Rac, Cmax) on Day 10
timeFrame: 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)
measure: PF-07321332 Peak-to-trough Ratio (PTR) on Day 10
timeFrame: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)
measure: PF-07321332 Apparent Clearance (CL/F) on Day 10
timeFrame: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)
measure: PF-07321332 Apparent Volume of Distribution (Vz/F) on Day 10
timeFrame: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)
measure: PF-07321332 Terminal Elimination Half-life (t½) on Day 10
timeFrame: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 and 48 hours)
measure: PF-07321332 Area Under the Plasma Concentration-time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) on Day 10
timeFrame: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 and 48 hours)
measure: PF-07321332 Trough Concentration (Ctrough) on Day 5
timeFrame: Day 5 (pre-dose)
measure: PF-07321332 Trough Concentration (Ctrough) on Day 8
timeFrame: Day 8 (pre-dose)
measure: PF-07321332 Trough Concentration (Ctrough) on Day 10 (Pre-dose)
timeFrame: Day 10 (pre-dose)
measure: PF-07321332 Trough Concentration (Ctrough) on Day 10 (12 Hours After Last Dose)
timeFrame: Day 10 (12 hours after last dose)
Secondary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
timeFrame: From baseline up to Day 42
measure: Number of Participants With Vital Signs Data Meeting Pre-Specified Categorization Criteria
timeFrame: Day 1 (pre-dose, within 1-2 hours after morning dose), Day 10 (pre-dose, within 1-2 hours after morning dose)
measure: Number of Participants With Laboratory Abnormalities
timeFrame: Day-1, Day 2, Day 5, Day 8, Day 10, Day 12.
measure: Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Categorization Criteria
timeFrame: Day 1 (pre-dose, within 1-2 hours after morning dose), Day 10 (pre-dose, within 1-2 hours after morning dose)
measure: Ritonavir Maximum Observed Plasma Concentration (Cmax) on Day 1
timeFrame: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)
measure: Ritonavir Maximum Observed Plasma Concentration (Cmax) on Day 10
timeFrame: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours)
measure: Ritonavir Time for Maximum Observed Plasma Concentration (Tmax) on Day 1
timeFrame: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours)
measure: Ritonavir Time for Maximum Observed Plasma Concentration (Tmax) on Day 10
timeFrame: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours)
measure: Ritonavir Area Under the Plasma Concentration-time Profile From Time Zero to Time Point on 12 Hours (AUC12) on Day 1
timeFrame: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)
measure: Ritonavir Area Under the Plasma Concentration-time Profile From Time Zero to Time Tau (Where Tau=12 Hours [Twice Daily Dosing]) (AUCtau) on Day 10
timeFrame: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)
measure: Ritonavir Area Under the Plasma Concentration-time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) on Day 10
timeFrame: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, and 48 hours)
measure: Ritonavir Average Plasma Concentration Over the Dosing Interval (Cav) on Day 10
timeFrame: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)
measure: Ritonavir Apparent Clearance (CL/F) on Day 10
timeFrame: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)
measure: Ritonavir Apparent Volume of Distribution (Vz/F) on Day 10
timeFrame: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)
measure: Ritonavir Terminal Elimination Half-life (t½) on Day 10
timeFrame: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, and 48 hours)
measure: Ritonavir Trough Concentration (Ctrough) on Day 5
timeFrame: Day 5 (pre-dose)
measure: Ritonavir Trough Concentration (Ctrough) on Day 8
timeFrame: Day 8 (pre-dose)
measure: Ritonavir Trough Concentration (Ctrough) on Day 10 (Pre-dose)
timeFrame: Day 10 (pre-dose)
measure: Ritonavir Trough Concentration (Ctrough) on Day 10 (12 Hours After Last Dose)
timeFrame: Day 10 (12 hours after last dose)
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan Hospital,Fudan University
state: Shanghai
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: