A Study of PBI-200 With Ritonavir or Cobicistat in Healthy Volunteers
- Conditions
- Drug-drug Interaction
- Interventions
- Registration Number
- NCT05692570
- Lead Sponsor
- Pyramid Biosciences
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 21
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single-sequence, 3-period PBI-200 Tablet 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. Single-sequence, 3-period Ritonavir Oral Tablet 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. Single-sequence, 3-period Cobicistat Oral Tablet 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.
- Primary Outcome Measures
Name Time Method Maximum Plasma Concentration [C(max)] of PBI-200 11 days Maximum (peak) plasma drug concentration
Incidence, frequency and severity of adverse events (AEs) 45 days Area Under the Concentration-Time Curve (AUC) from time zero to the time of the last measurable concentration [AUC(0-t)] 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.
AUC from time zero to infinity [AUC(0-inf)] 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.
Terminal elimination half-life [T(1/2)] 11 days Apparent terminal elimination half-life, calculated as ln(2)/kel.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Celerion, Inc.
🇺🇸Tempe, Arizona, United States