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

NCT04962022 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: C46710152021-003308-42
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Participant

Keywords

Drug-drug interaction; Itraconazole; CYP3A4 inhibitor

Outcome Measures

Primary Outcomes (2)

• Maximum Observed Concentration (Cmax) of PF-07321332

  The Cmax of PF-07321332 in the study was observed directly from data.

  Days 1, 2, 3 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, and 48 hours postdose on Day 3) in Period 1; Days 1, 4, 5, 6 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48, and 72 hours postdose on Day 6) of Period 2.

• Area Under the Plasma Concentration-time Profile From Time Zero to Time Tau (τ), Where Tau=12-hour Dosing Interval(AUCtau) for PF-07321332

  The AUCtau of PF-07321332 was determined by Linear/Log trapezoidal method.

  Days 1, 2, 3 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, and 48 hours postdose on Day 3) in Period 1; Days 1, 4, 5, 6 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48, and 72 hours postdose on Day 6) of Period 2.

Secondary Outcomes (11)

• Number of Participants With Treatment Emergent Adverse Events (TEAEs)

  Screening up to Day 35

• Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality)

  Screening up to Day 9 of Period 2 or Early termination/discontinuation.

• Number of Participants With Clinically Significant 12-lead Electrocardiogram (ECG) Findings

  Screening up to Day 9 of Period 2 or Early termination/discontinuation.

• Change From Baseline in Vital Signs Data - Supine Systolic Blood Pressure

  Screening up to Day 9 of Period 2 or Early termination/discontinuation.

• Change From Baseline in Vital Signs Data - Supine Diastolic Blood Pressure

  Screening up to Day 9 of Period 2 or Early termination/discontinuation.

Study Arms (2)

Period 1

EXPERIMENTAL

PF-07321332/ritonavir orally

Drug: PF-07321332/ritonavir

Period 2

EXPERIMENTAL

Itraconazole + PF-07321332/ritonavir orally.

Drug: Itraconazole; Drug: PF-07321332/ritonavir

Interventions

PF-07321332/ritonavir DRUG

Administered orally every 12 hours for days for a total of 5 doses from Day 1 through Day 3

Period 1

Itraconazole DRUG

Administered orally once daily for 8 days from Days 1 through 8

Period 2

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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). -

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Brussels Clinical Research Unit

Brussels, Bruxelles-capitale, Région de, B-1070, Belgium

Location

Related Links

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

MeSH Terms

Interventions

nirmatrelvir and ritonavir drug combination; Itraconazole

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a Phase I, fixed sequence, 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.

Study Record Dates

• First Submitted: July 10, 2021
• First Posted: July 14, 2021
• Study Start: July 20, 2021
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: July 13, 2023
• Results First Posted: July 13, 2023

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)