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

NCT05692570 | Completed Phase 1 FDA Drug

• 1 other identifier: PBI-200-106
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Drug-drug Interaction

Outcome Measures

Primary Outcomes (5)

• Maximum Plasma Concentration [C(max)] of PBI-200

  Maximum (peak) plasma drug concentration

  11 days

• 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

• 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

• Terminal elimination half-life [T(1/2)]

  Apparent terminal elimination half-life, calculated as ln(2)/kel.

  11 days

• Incidence, frequency and severity of adverse events (AEs)

  45 days

Study Arms (1)

Single-sequence, 3-period

EXPERIMENTAL

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.

Drug: PBI-200 Tablet; Drug: Ritonavir Oral Tablet; Drug: Cobicistat Oral Tablet

Interventions

PBI-200 Tablet DRUG

PBI-200 is a TRK inhibitor

Single-sequence, 3-period

Ritonavir Oral Tablet DRUG

Ritonavir is a potent CYP3A inhibitor

Also known as: Norvir

Single-sequence, 3-period

Cobicistat Oral Tablet DRUG

Cobicistat is a potent CYP3A inhibitor

Also known as: Tybost

Single-sequence, 3-period

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pyramid Biosciences: lead

Study Sites (1)

Celerion, Inc.

Tempe, Arizona, 85283, United States

Location

MeSH Terms

Interventions

Ritonavir; Cobicistat

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbamates; Acids, Acyclic; Carboxylic Acids

Study Officials

• Chief Medical Officer

  Pyramid Biosciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single-sequence, three-periods

Study Record Dates

• First Submitted: January 11, 2023
• First Posted: January 20, 2023
• Study Start: September 9, 2022
• Primary Completion: November 12, 2022
• Study Completion: November 12, 2022
• Last Updated: January 20, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)