A Formulation Bridging and Food Effect Study of PBI-200 in Healthy Volunteers
- Conditions
- Food EffectFormulation Bridging
- Interventions
- Drug: PBI-200 CapsuleDrug: PBI-200 TabletDrug: PBI-200 Suspension
- Registration Number
- NCT05690932
- Lead Sponsor
- Pyramid Biosciences
- Brief Summary
This is a single-dose, two-part, crossover formulation bridging and food effect study to assess the effect of formulation and food on the absorption and bioavailability of PBI-200 in normal, healthy volunteers.
- Detailed Description
This is a single-dose, two-part crossover formulation bridging (Part A) and tablet food effect (Part B) study in normal, healthy volunteers. Part A will be conducted to evaluate the pharmacokinetics (PK) and relative bioavailability of 3 formulations of PBI-200; each volunteer will serve as their own control. In Part B, PBI-200 tablets will be dosed under fasting and fed (low-fat and high-fat meals) conditions to evaluate the effect of food on the PK of PBI-200.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 33
- Male or non-pregnant, non-lactating 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
- CROSSOVER
- Arm && Interventions
Group Intervention Description Capsule PBI-200 Capsule Study drug will be administered with water after an overnight fast. Tablet PBI-200 Tablet Study drug will be administered with water after an overnight fast. Fasted PBI-200 Tablet Study drug will be administered with water after an overnight fast. Low-fat Meal PBI-200 Tablet Study drug will be administered with water after an overnight fast, after which time a standard low-fat breakfast will be given. High-fat Meal PBI-200 Tablet Study drug will be administered with water after an overnight fast, after which time a standard high-fat breakfast will be given. Suspension PBI-200 Suspension Study drug will be administered with water after an overnight fast.
- Primary Outcome Measures
Name Time Method Maximum Plasma Concentration [C(max)] of PBI-200 8 days Maximum (peak) plasma drug concentration
Area Under the Concentration-Time Curve (AUC) of PBI-200 from time zero to the time of th last measurable concentration [AUC(0-t)] 8 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 of PBI-200 from time zero to infinity [AUC(0-inf)] 8 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.
- Secondary Outcome Measures
Name Time Method Time to Maximum Concentration [T(max)] of PBI-200 8 days T(max) will be determined from the observed plasma concentration data
Incidence, frequency and severity of adverse events (AEs) 14 days Terminal elimination half-life [T(1/2)] 8 days Apparent terminal elimination half-life, calculated as ln(2)/kel
Trial Locations
- Locations (1)
Bio-Kinetic Clinical Applications
🇺🇸Springfield, Missouri, United States
Bio-Kinetic Clinical Applications🇺🇸Springfield, Missouri, United States