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Completed

NCT Number: NCT05692570

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

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

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Key information

Conditions

Drug-drug Interaction

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Celerion, Inc.

Tempe, Arizona, 85283, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PBI-200 Tablet

Drug

PBI-200 is a TRK inhibitor

Ritonavir Oral Tablet

Drug

Ritonavir is a potent CYP3A inhibitor

Other names: Norvir

Cobicistat Oral Tablet

Drug

Cobicistat is a potent CYP3A inhibitor

Other names: Tybost

Primary outcomes

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

    Time frame: 11 days

    Maximum (peak) plasma drug concentration

  2. Area Under the Concentration-Time Curve (AUC) from time zero to the time of the last measurable concentration [AUC(0-t)]

    Time frame: 11 days

    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.

  3. AUC from time zero to infinity [AUC(0-inf)]

    Time frame: 11 days

    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.

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

    Time frame: 11 days

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

  5. Incidence, frequency and severity of adverse events (AEs)

    Time frame: 45 days

Sponsors and collaborators

Lead sponsor

Pyramid Biosciences

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 20, 2023
Registry last updated
Jan 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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