NCT04962022

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	PF-07321332/ritonavir	Administered orally every 12 hours for days for a total of 5 doses from Day 1 through Day 3
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

Timeline

• Start date: 2021-07-20
• Primary completion: 2021-09-30
• Completion: 2021-09-30
• First posted: 2021-07-14
• Last updated: 2023-07-13
• Results posted: 2023-07-13

Locations

1 site across 1 country: Belgium

Regulatory

• FDA-regulated drug study