Phase 1
Completed N=14
A Study to Learn About the Study Medicine PF-07321332 and Ritonavir in Adult Healthy Chinese Participants.
Healthy Participants
Source: ClinicalTrials.gov NCT05339334 ↗
Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcomePrimary: PF-07321332 Maximum Observed Plasma Concentration (Cmax) on Day 1 — 3082 nanograms per milliliter (ng/mL)
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY PF-07321332 Maximum Observed Plasma Concentration (Cmax) on Day 1 |
3082 | — |
| PRIMARY PF-07321332 Maximum Observed Plasma Concentration (Cmax) on Day 10 |
4500 | — |
| PRIMARY PF-07321332 Time for Maximum Observed Plasma Concentration (Tmax) on Day 1 |
1.76 | — |
| PRIMARY PF-07321332 Time for Maximum Observed Plasma Concentration (Tmax) on Day 10 |
2.00 | — |
| PRIMARY PF-07321332 Area Under the Plasma Concentration-time Profile From Time Zero to Time Point on 12 Hours (AUC12) on Day 1 |
19660 | — |
| PRIMARY PF-07321332 Area Under the Plasma Concentration-time Profile From Time Zero to Time Tau (Where Tau=12 Hours) (AUCtau) on Day 10 |
32010 | — |
| PRIMARY PF-07321332 Average Plasma Concentration Over the Dosing Interval (Cav) on Day 10 |
2668 | — |
| PRIMARY PF-07321332 Accumulation Ratio for AUCtau (Rac) on Day 10 |
1.627 | — |
| PRIMARY PF-07321332 Accumulation Ratio for Cmax (Rac, Cmax) on Day 10 |
1.461 | — |
| PRIMARY PF-07321332 Peak-to-trough Ratio (PTR) on Day 10 |
4.517 | — |
| PRIMARY PF-07321332 Apparent Clearance (CL/F) on Day 10 |
9.379 | — |
| PRIMARY PF-07321332 Apparent Volume of Distribution (Vz/F) on Day 10 |
91.01 | — |
| PRIMARY PF-07321332 Terminal Elimination Half-life (t½) on Day 10 |
6.842 | — |
| PRIMARY PF-07321332 Area Under the Plasma Concentration-time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) on Day 10 |
41460 | — |
| PRIMARY PF-07321332 Trough Concentration (Ctrough) on Day 5 |
1389 | — |
| PRIMARY PF-07321332 Trough Concentration (Ctrough) on Day 8 |
1481 | — |
| PRIMARY PF-07321332 Trough Concentration (Ctrough) on Day 10 (Pre-dose) |
1333 | — |
| PRIMARY PF-07321332 Trough Concentration (Ctrough) on Day 10 (12 Hours After Last Dose) |
997.4 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) |
6; 0 | — |
| SECONDARY Number of Participants With Vital Signs Data Meeting Pre-Specified Categorization Criteria |
— | — |
| SECONDARY Number of Participants With Laboratory Abnormalities |
2; 1; 2; 2 | — |
| SECONDARY Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Categorization Criteria |
— | — |
| SECONDARY Ritonavir Maximum Observed Plasma Concentration (Cmax) on Day 1 |
545.8 | — |
| SECONDARY Ritonavir Maximum Observed Plasma Concentration (Cmax) on Day 10 |
1109 | — |
| SECONDARY Ritonavir Time for Maximum Observed Plasma Concentration (Tmax) on Day 1 |
2.00 | — |
| SECONDARY Ritonavir Time for Maximum Observed Plasma Concentration (Tmax) on Day 10 |
2.00 | — |
| SECONDARY Ritonavir Area Under the Plasma Concentration-time Profile From Time Zero to Time Point on 12 Hours (AUC12) on Day 1 |
3136 | — |
| SECONDARY 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 |
6152 | — |
| SECONDARY Ritonavir Area Under the Plasma Concentration-time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) on Day 10 |
7118 | — |
| SECONDARY Ritonavir Average Plasma Concentration Over the Dosing Interval (Cav) on Day 10 |
512.9 | — |
| SECONDARY Ritonavir Apparent Clearance (CL/F) on Day 10 |
16.25 | — |
| SECONDARY Ritonavir Apparent Volume of Distribution (Vz/F) on Day 10 |
123.0 | — |
| SECONDARY Ritonavir Terminal Elimination Half-life (t½) on Day 10 |
5.471 | — |
| SECONDARY Ritonavir Trough Concentration (Ctrough) on Day 5 |
233.3 | — |
| SECONDARY Ritonavir Trough Concentration (Ctrough) on Day 8 |
212.8 | — |
| SECONDARY Ritonavir Trough Concentration (Ctrough) on Day 10 (Pre-dose) |
200.8 | — |
| SECONDARY Ritonavir Trough Concentration (Ctrough) on Day 10 (12 Hours After Last Dose) |
134.9 | — |
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
Data sourced from ClinicalTrials.gov (NCT05339334). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.