Formulation Bridging, Food Effect
Conditions
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.
Interventions
DRUGPBI-200 Tablet
Single dose of PBI-200 tablet
DRUGPBI-200 Capsule
Single dose of PBI-200 capsule
DRUGPBI-200 Suspension
Single dose of PBI-200 suspension
Sponsors
Pyramid Biosciences
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single-dose, open-label, randomized, three-way crossover design
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Time to Maximum Concentration [T(max)] of PBI-200 | 8 days | T(max) will be determined from the observed plasma concentration data |
| Terminal elimination half-life [T(1/2)] | 8 days | Apparent terminal elimination half-life, calculated as ln(2)/kel |
| Incidence, frequency and severity of adverse events (AEs) | 14 days | — |
Countries
United States
Outcome results
None listed