Drug-Drug Interaction Study Assessing Effect of Itraconazole on PF-07321332/Ritonavir in Healthy Participants

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04962022
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arms: 2
• Actual Duration (Months): 2.4
• Patients Per Site Per Month: 5.1

Study Details

Study Description

Brief Summary

The purpose of this study is to estimate the effect of a strong inhibitor of CYP3A4 (itraconazole) on the pharmacokinetics (PK) of PF-07321332/ritonavir in healthy participants.

Condition or Disease	Intervention/Treatment	Phase
Healthy Participant	Drug: PF-07321332/ritonavir; Drug: Itraconazole; Drug: PF-07321332/ritonavir	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: Non-Randomized
• 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.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: Jul 20, 2021
• Actual Primary Completion Date: Sep 30, 2021
• Actual Study Completion Date: Sep 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Period 1 PF-07321332/ritonavir orally	Drug: PF-07321332/ritonavir; 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.	Drug: Itraconazole; Administered orally once daily for 8 days from Days 1 through 8; Drug: PF-07321332/ritonavir; Administered orally BID for 3 day for a total on 5 doses starting on Day 4 through Day 6

Outcome Measures

Primary Outcome Measures

1. Maximum Observed Plasma Concentration (Cmax) of PF-07321332/ritonavir when administered alone [Period 1 - Day 1 pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, and 48 hour post-dose]

2. Cmax of PF-07321332/ritonavir when administered with itraconazole [Period 2 - Day 1 pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48, and 72 hour post-dose]

3. Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of PF-07321332/ritonavir when administered alone [Period 1 - Day 1 pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, and 48 hour post-dose]

4. AUCinf of PF-07321332/ritonavir when administered with itraconazole [Period 2 - Day 1 pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48, and 72 hour post-dose]

Secondary Outcome Measures

1. Assessment of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) [Up to Day 49]

2. Assessment of Participants With Laboratory Abnormalities [Up to Day 14]

3. Assessment of Participants With Vital Signs Abnormalities of PF-07321332/ritonavir [Period 1 up to Day 4]

4. Assessment of Participants With Vital Signs Abnormalities of PF-07321332/ritonavir with itraconazole [Period 2 up to Day 9]

5. Assessment of Abnormalities in Physical Examination (PE) [Screening]

6. Assessment of Participants With Clinically Significant Change in Electrocardiogram (ECG) Findings of PF-07321332/ritonavir [Period 1 up to Day 4]

7. Assessment of Participants with Clinically Significant ECG findings of PF-07321332/ritonavir with itraconazole [Period 2 up to Day 9]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. 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.

2. Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.

3. Female participants must have a negative pregnancy test.

4. BMI of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb). -

Exclusion Criteria:

1. Positive test result for SARS-CoV-2 infection at the time of Screening or Day -1.

2. 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).

3. 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).

4. Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).

5. History of HIV infection, hepatitis B, or hepatitis C; positive testing for HIV, HBsAg, or HCVAb. Hepatitis B vaccination is allowed.

6. 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Brussels Clinical Research Unit	Brussels	Bruxelles-capitale, Région DE	Belgium	B-1070

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT04962022
• Other Study ID Numbers: C4671015; 2021-003308-42
• First Posted: Jul 14, 2021
• Last Update Posted: Oct 12, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Pfizer: Drug-drug interaction; Itraconazole; CYP3A4 inhibitor
• Additional relevant MeSH terms: Ritonavir; Itraconazole

Study Results

No Results Posted as of Oct 12, 2021