NCT05692570

A Study of PBI-200 With Ritonavir or Cobicistat in Healthy Volunteers

A Phase 1, Open-label Drug Interaction Study of PBI-200 With Ritonavir or Cobicistat in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Pyramid Biosciences · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a drug-drug interaction study in volunteers to evaluate the effect of ritonavir or cobicistat on the pharmacokinetics (PK) of PBI-200.

Detailed description

This is an open-label, single-sequence, three-period drug-drug interaction study in healthy male and female volunteers to evaluate the effect of a potent CYP3A inhibitor, ritonavir or cobicistat, on the single dose PK of orally administered PBI-200. It is expected that co-administration of ritonavir or cobicistat with PBI-200 will increase the exposure of PBI 200.

Conditions

• Drug-drug Interaction

Interventions

Type	Name	Description
DRUG	PBI-200 Tablet	PBI-200 is a TRK inhibitor
DRUG	Ritonavir Oral Tablet	Ritonavir is a potent CYP3A inhibitor
DRUG	Cobicistat Oral Tablet	Cobicistat is a potent CYP3A inhibitor

Timeline

• Start date: 2022-09-09
• Primary completion: 2022-11-12
• Completion: 2022-11-12
• First posted: 2023-01-20
• Last updated: 2023-01-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study