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

Completed · Phase 1

Conditions studied: Drug-drug Interaction

In brief

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

Key facts

Study ID

NCT05692570

Run by

Pyramid Biosciences

People needed

21

Starts

2022-09-09

Expected to finish

2022-11-12

Last updated by the study team

2023-01-20

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

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.

Where it is running

• Celerion, Inc. — Tempe, Arizona, United States

Full record on ClinicalTrials.gov

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