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

Drug-drug Interaction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05692570
• Other study ID #: PBI-200-106
• Status: Completed
• Phase: Phase 1
• Start date: September 9, 2022
• Est. completion date: November 12, 2022

Study information

• Verified date: January 2023
• Source: Pyramid Biosciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: November 12, 2022
• Est. primary completion date: November 12, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Drug-drug Interaction

Intervention

Drug:
• PBI-200 Tablet
PBI-200 is a TRK inhibitor
• Ritonavir Oral Tablet
Ritonavir is a potent CYP3A inhibitor
• Cobicistat Oral Tablet
Cobicistat is a potent CYP3A inhibitor

Locations

Country	Name	City	State
United States	Celerion, Inc.	Tempe	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Pyramid Biosciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Plasma Concentration [C(max)] of PBI-200	Maximum (peak) plasma drug concentration	11 days
Primary	Area Under the Concentration-Time Curve (AUC) from time zero to the time of the last measurable concentration [AUC(0-t)]	AUC, calculated using linear up / log down trapezoidal method from time zero to time t, where t is the time of the last measurable concentration.	11 days
Primary	AUC from time zero to infinity [AUC(0-inf)]	AUC from time zero to infinity, AUC(0-inf) = AUC(0-t) + Ct/kel, where kel is the terminal rate constant and Ct is the last measurable concentration.	11 days
Primary	Terminal elimination half-life [T(1/2)]	Apparent terminal elimination half-life, calculated as ln(2)/kel.	11 days
Primary	Incidence, frequency and severity of adverse events (AEs)		45 days