Drug-Drug Interaction Study Assessing Effect of Itraconazole on PF-07321332/Ritonavir in Healthy Participants
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|ClinicalTrials.gov Identifier: NCT04962022|
Recruitment Status : Completed
First Posted : July 14, 2021
Last Update Posted : October 12, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Healthy Participant||Drug: PF-07321332/ritonavir Drug: Itraconazole||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||This is a Phase I, fixed sequnce, 2-period study to evaluate the effect of the strong CYP3A4 inhibitor, itraconazole, on the PK of PF-07321332 and ritonavir in healthy participants. A total of 12 healthy participants will be enrolled into this study.|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||COVID-19: A PHASE 1, OPEN-LABEL, FIXED SEQUENCE, 2-PERIOD CROSSOVER STUDY TO ESTIMATE THE EFFECT OF ITRACONAZOLE ON THE PHARMACOKINETICS OF PF-07321332/RITONAVIR IN HEALTHY PARTICIPANTS|
|Actual Study Start Date :||July 20, 2021|
|Actual Primary Completion Date :||September 30, 2021|
|Actual Study Completion Date :||September 30, 2021|
Experimental: Period 1
Administered orally every 12 hours for days for a total of 5 doses from Day 1 through Day 3
Experimental: Period 2
Itraconazole + PF-07321332/ritonavir orally.
Administered orally once daily for 8 days from Days 1 through 8
Administered orally BID for 3 day for a total on 5 doses starting on Day 4 through Day 6
- Maximum Observed Plasma Concentration (Cmax) of PF-07321332/ritonavir when administered alone [ Time Frame: Period 1 - Day 1 pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, and 48 hour post-dose ]
- Cmax of PF-07321332/ritonavir when administered with itraconazole [ Time Frame: Period 2 - Day 1 pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48, and 72 hour post-dose ]
- Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of PF-07321332/ritonavir when administered alone [ Time Frame: Period 1 - Day 1 pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, and 48 hour post-dose ]
- AUCinf of PF-07321332/ritonavir when administered with itraconazole [ Time Frame: Period 2 - Day 1 pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48, and 72 hour post-dose ]
- Assessment of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) [ Time Frame: Up to Day 49 ]
- Assessment of Participants With Laboratory Abnormalities [ Time Frame: Up to Day 14 ]
- Assessment of Participants With Vital Signs Abnormalities of PF-07321332/ritonavir [ Time Frame: Period 1 up to Day 4 ]
- Assessment of Participants With Vital Signs Abnormalities of PF-07321332/ritonavir with itraconazole [ Time Frame: Period 2 up to Day 9 ]
- Assessment of Abnormalities in Physical Examination (PE) [ Time Frame: Screening ]
- Assessment of Participants With Clinically Significant Change in Electrocardiogram (ECG) Findings of PF-07321332/ritonavir [ Time Frame: Period 1 up to Day 4 ]
- Assessment of Participants with Clinically Significant ECG findings of PF-07321332/ritonavir with itraconazole [ Time Frame: Period 2 up to Day 9 ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 60 Years (Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- Male and female participants who are overtly healthy as determined by medical evaluation including medical history, PE, laboratory tests, vital signs and standard 12 lead ECGs.
- Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
- Female participants must have a negative pregnancy test.
- BMI of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb). -
- 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 NYHA 1, underlying structural heart disease, Wolff Parkinson-White syndrome).
- Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
- History of HIV infection, hepatitis B, or hepatitis C; positive testing for HIV, HBsAg, or 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04962022
|Brussels Clinical Research Unit|
|Brussels, Bruxelles-capitale, Région DE, Belgium, B-1070|
|Study Director:||Pfizer CT.gov Call Center||Pfizer|
|Other Study ID Numbers:||
2021-003308-42 ( EudraCT Number )
|First Posted:||July 14, 2021 Key Record Dates|
|Last Update Posted:||October 12, 2021|
|Last Verified:||October 2021|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Plan Description:||Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
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