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

Healthy Participants Clinical Trial

Official title:

A Phase 1, Single Center, Open-label Study of PF-07321332 Administrated as Multiple Oral Doses in Healthy Chinese Participants.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05339334
• Other study ID #: C4671016
• Status: Completed
• Phase: Phase 1
• Start date: March 10, 2022
• Est. completion date: April 21, 2022

Study information

• Verified date: June 2022
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: April 21, 2022
• Est. primary completion date: April 21, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Participants

Intervention

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

Locations

Country	Name	City	State
China	Huashan Hospital,Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Observed Plasma Concentration (Cmax) of PF-07321332		Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours) and Day 10 (1, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, and 48 hours)
Primary	Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-07321332		Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours) and Day 10 (1, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, and 48 hours)
Primary	Area under the plasma concentration-time profile from time 0 to time point on 12 hours of PF-07321332		Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)
Primary	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 of PF-07321332		Day 10 (1, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, and 48 hours)
Primary	Average concentration (Cav) of PF-07321332		Day 10 (1, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, and 48 hours)
Primary	Accumulation ratio for AUCtau following multiple dosing (Rac) of PF-07321332		Day 10 (1, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, and 48 hours)
Primary	Rac,Cmax of PF-07321332	Accumulation ratio for Cmax	Day 10 (1, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, and 48 hours)
Primary	Peak-to-trough ratio (PTR) of PF-07321332		Day 10 (1, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, and 48 hours)
Primary	Apparent clearance (CL/F) of PF-07321332		Day 10 (1, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, and 48 hours)
Primary	Apparent volume of distribution (Vz/F) of PF-07321332		Day 10 (1, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, and 48 hours)
Primary	Terminal elimination half life (T½) of PF-07321332		Day 10 (1, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, and 48 hours)
Primary	Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-07321332		Day 10 (1, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, and 48 hours)
Primary	Pre-dose concentration (Ctrough) of PF-07321332		Day 5 (pre-dose), Day 8 (pre-dose) and Day 10 (1, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, and 48 hours)
Secondary	Number of participants reporting an adverse event		From baseline up to Day 45
Secondary	Number of participants reporting abnormal vital signs		From baseline up to Day 45
Secondary	Number of participants reporting abnormal ECGs		From baseline up to Day 45
Secondary	Number of participants reporting abnormal clinical safety laboratory tests		From baseline up to Day 45
Secondary	Cmax of ritonavir		Day 1 (0, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours) and Day 10 (1, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, and 48 hours)
Secondary	Tmax of ritonavir		Day 1 (0, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours) and Day 10 (1, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, and 48 hours)
Secondary	AUC12 of ritonavir		Day 1 (0, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)
Secondary	AUCtau of ritonavir		Day 10 (1, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, and 48 hours)
Secondary	AUClast of ritonavir		Day 10 (1, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, and 48 hours)
Secondary	Cav of ritonavir		Day 10 (1, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, and 48 hours)
Secondary	Rac of ritonavir		Day 10 (1, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, and 48 hours)
Secondary	Rac,Cmax of ritonavir	Accumulation ratio for Cmax	Day 10 (1, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, and 48 hours)
Secondary	PTR of ritonavir		Day 10 (1, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, and 48 hours)
Secondary	CL/F of ritonavir		Day 10 (1, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, and 48 hours)
Secondary	Vz/F of ritonavir		Day 10 (1, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, and 48 hours)
Secondary	T1/2 of ritonavir		Day 10 (1, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, and 48 hours)
Secondary	Ctrough of ritonavir		Day 5 (pre-dose), Day 8 (pre-dose) and Day 10 (1, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, and 48 hours)

External Links

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