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

NCT ID: NCT05692570

Last Updated: 2023-01-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-09
• Study Completion Date: 2022-11-12

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single-sequence, 3-period

Period 1: single dose of PBI-200; Period 2: daily dosing of ritonavir with a single dose of PBI-200 co-administered once ritonavir steady state reached; Period 3: daily dosing of cobicistat with a single dose of PBI-200 co-administered once cobicistat steady state reached.

Group Type: EXPERIMENTAL

PBI-200 Tablet

Intervention Type: DRUG

PBI-200 is a TRK inhibitor

Ritonavir Oral Tablet

Intervention Type: DRUG

Ritonavir is a potent CYP3A inhibitor

Cobicistat Oral Tablet

Intervention Type: DRUG

Cobicistat is a potent CYP3A inhibitor

Interventions

PBI-200 Tablet

PBI-200 is a TRK inhibitor

Intervention Type: DRUG

Ritonavir Oral Tablet

Ritonavir is a potent CYP3A inhibitor

Intervention Type: DRUG

Cobicistat Oral Tablet

Cobicistat is a potent CYP3A inhibitor

Intervention Type: DRUG

Other Intervention Names

Norvir; Tybost

Eligibility Criteria

Inclusion Criteria

• Male or female between 18 and 55 years of age (inclusive).
• Body Mass Index (BMI) between 18.0 and 32.0 kg/m² (inclusive).
• Non-smoking/non-vaping, healthy, with no history of clinically relevant medical illness.

Exclusion Criteria

• History or presence of clinically significant cardiovascular, pulmonary, respiratory, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease which, in the opinion of the Investigator, would jeopardize the safety of the volunteer or impact the validity of the study results.
• History of gastrointestinal/hepatobiliary or other surgery that may affect PK profiles (i.e., hepatectomy, gastric, bypass, or digestive organ resection).
• Intolerance to repeated venipuncture.
• Smoking or use of tobacco products (including vaping) within 3 months prior to the first study drug administration.
• Have a positive drug/alcohol screen, or history or presence of alcoholism or drug abuse within 6 months of first study drug administration.
• Volunteers with a corrected QT using Fridericia's formula (QTcF) prolongation over 450 milliseconds at Screening.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pyramid Biosciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chief Medical Officer

Role: STUDY_DIRECTOR

Pyramid Biosciences

Locations

Celerion, Inc.

Tempe, Arizona, United States

Countries

United States

Other Identifiers

PBI-200-106

Identifier Type: -

Identifier Source: org_study_id