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

Pfizer14 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Healthy Participants

Interventions

PF-07321332/ritonavirDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Huashan Hospital,Fudan University

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

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

Cmax is maximum plasma concentration .

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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.

Time frame: 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.

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

Data from ClinicalTrials.gov

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Secondary Outcomes

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

An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious AE was any untoward medical occurrence at any dose that resulted in death; was life-threatening; required hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth, was a suspected transmission via a Pfizer product of an infectious agent,pathogenic or non-pathogenic. An adverse event is considered a Treatment-Emergent Adverse Event (TEAE) if the event started during the effective duration of treatment. All events that started on or after the first dosing day and time/start time, if collected, but before the end of the study would be flagged as TEAEs.

Time frame: From baseline up to Day 42

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

Vital signs evaluations included supine blood pressure (BP) and pulse rate. The pre specified criteria for vital signs included systolic blood pressure (BP) minimum (min.) less than (\<) 90 millimeter of mercury (mmHg); systolic BP change from baseline maximum (max.) decrease \>= 30 mmHg, max. increase \>=30 mmHg; diastolic BP min. \<50mmHg; diastolic BP change from baseline max. decrease \>=20, max. increase \>=20; seated pulse rate min. \<40 beats per minute (bpm) and max. \>120 bpm. Participants who met at least 1 pre- specified criteria would be reported in outcome measure.

Time frame: 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

Safety laboratory assessments included hematology, urinalysis, and clinical chemistry.

Time frame: Day-1, Day 2, Day 5, Day 8, Day 10, Day 12.

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

The average of the triplicate readings collected at each assessment time was calculated for each ECG parameter. Baseline was defined as the average of the triplicate pre-dose recordings on Day 1. Pre-defined categories for corrected QT (Fridericia method) (QTcF): Absolute value (milliseconds\[msec\]) \>450 and ≤480, or \>480 and ≤500, or \>500; Increase from baseline in QTcF (msec) \>30 and ≤60, or\>60. Pre-defined categories for PR and QRS: PR (msec) max. ≥300; PR (msec) increase from baseline: baseline \>200 and max. ≥25% increase, or baseline ≤200 and max. ≥50% increase; QRS (msec) max. ≥140; QRS (msec) increase from baseline ≥50% increase. Participants who met at least 1 pre- specified criteria would be reported in outcome measure.

Time frame: 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

Cmax is maximum plasma concentration

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

Ritonavir Maximum Observed Plasma Concentration (Cmax) on Day 10

Cmax is maximum plasma concentration

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

Ritonavir Time for Maximum Observed Plasma Concentration (Tmax) on Day 1

Tmax is the time for maximum plasma concentration

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

Ritonavir Time for Maximum Observed Plasma Concentration (Tmax) on Day 10

Tmax is the time for maximum plasma concentration

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

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

This was determined by linear/Log trapezoidal method - reported as AUC12 on Day 1.

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

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

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.

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

Ritonavir 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)

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

Ritonavir Average Plasma Concentration Over the Dosing Interval (Cav) on Day 10

This was determined by AUCtau/tau.

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

Ritonavir Apparent Clearance (CL/F) on Day 10

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

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

Ritonavir Apparent Volume of Distribution (Vz/F) on Day 10

Apparent oral volume of distribution. This was determined by Dose/(AUCtau\*kel)

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

Ritonavir 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.

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

Ritonavir Trough Concentration (Ctrough) on Day 5

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

Time frame: Day 5 (pre-dose)

Ritonavir Trough Concentration (Ctrough) on Day 8

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

Time frame: Day 8 (pre-dose)

Ritonavir Trough Concentration (Ctrough) on Day 10 (Pre-dose)

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

Time frame: Day 10 (pre-dose)

Ritonavir Trough Concentration (Ctrough) on Day 10 (12 Hours After Last Dose)

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

Time frame: Day 10 (12 hours after last dose)