Phase 1
Completed N=12
Drug-Drug Interaction Study to Estimate the Effect of PF-07321332/Ritonavir and Ritonavir on Midazolam in Healthy Participants
Healthy Participants
Source: ClinicalTrials.gov NCT05032950 ↗
Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Oct 2023
Primary outcomePrimary: Maximum Plasma Concentration (Cmax) of Midazolam When Administered Alone and With PF-07321332/Ritonavir — 9.812; 36.18 ng/mL
Summary
The purpose of this study is to estimate the effect PF-07321332/Ritonavir and Ritonavir on Midazolam (a cytochrome P450 [CYP]3A4 substrate) in Healthy Adult Participants.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Plasma Concentration (Cmax) of Midazolam When Administered Alone and With PF-07321332/Ritonavir |
9.812; 36.18 | — |
| PRIMARY Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinity Time (AUCinf) of Midazolam When Administered Alone and With PF-07321332/Ritonavir |
26.13; 363.9 | — |
| PRIMARY Area Under the Plasma Concentration-time Profile From Time 0 to the Time of the Last Quantifiable Concentration (Clast) (AUClast) of Midazolam When Administered Alone and With PF-07321332/Ritonavir |
25.02; 353.8 | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) |
4; 9; 7; 4; 9; 7 | — |
| SECONDARY Number of Participants With Laboratory Abnormalities |
0; 0; 1; 0; 0; 1 | — |
| SECONDARY Number of Participants With Vital Signs Abnormalities |
0; 1; 0 | — |
| SECONDARY Number of Participants With Electrocardiogram (ECG) Abnormalities |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Cmax of Midazolam When Administered Alone and With Ritonavir |
9.812; 38.03 | — |
| SECONDARY AUCinf of Midazolam When Administered Alone and With Ritonavir |
26.13; 418.6 | — |
| SECONDARY AUClast of Midazolam When Administered Alone and With Ritonavir |
25.02; 408.8 | — |
| SECONDARY Apparent Clearance (CL/F) of Midazolam When Administered Alone, With PF-07321332/Ritonavir, and With Ritonavir |
76.57; 5.500; 4.776 | — |
| SECONDARY Apparent Volume of Distribution (Vz/F) of Midazolam When Administered Alone, With PF-07321332/Ritonavir, and With Ritonavir |
488.6; 79.84; 76.43 | — |
| SECONDARY Time for Cmax (Tmax) of Midazolam When Administered Alone, With PF-07321332/Ritonavir, and With Ritonavir |
1.00; 1.00; 1.02 | — |
| SECONDARY Terminal Half-life (t1/2) of Midazolam When Administered Alone, With PF-07321332/Ritonavir, and With Ritonavir |
4.988; 10.47; 11.54 | — |
Eligibility Criteria
Inclusion Criteria
- Female participants of childbearing potential must have a negative (urine or serum) pregnancy test.
- Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).
-
Exclusion Criteria
- Positive test result for SARS-CoV-2 infection at the time of Screening or Day -1.
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
- Clinically relevant abnormalities requiring treatment (eg, acute myocardial infarction, unstable ischemic conditions, evidence of ventricular dysfunction, serious tachy or brady arrhythmias) or indicating serious underlying heart disease (eg, prolonged PR interval, cardiomyopathy, heart failure greater than New York Heart Association (NYHA) 1, underlying structural heart disease, Wolff Parkinson-White syndrome).
- Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
- History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, HBsAg, or hepatitis C virus (HCVAb). Hepatitis B vaccination is allowed.
- Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality or other conditions or situations related to COVID-19 pandemic (eg, Contact with positive case, residence, or travel to an area with high incidence) that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
Data sourced from ClinicalTrials.gov (NCT05032950). 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.