Food Effect in Healthy Volunteers
Conditions
Keywords
Volunteer
Brief summary
This is a single-dose, open-label, randomized, three-way crossover study to assess the effect of food on the absorption and bioavailability of PBI-200.
Detailed description
This is a single-dose, open-label, randomized, three-way crossover study to assess the effect of food on the absorption and bioavailability of PBI-200, administered orally under fasted and fed conditions. The study will enroll 18 healthy adult volunteers to ensure study completion of at least 12 evaluable volunteers. The study will be conducted in 3 groups, with each group enrolling 6 volunteers. As this is a crossover study, each volunteer will serve as their own control.
Interventions
DRUGPBI-200
Single dose of PBI-200
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
Key Inclusion Criteria: * Male or non-pregnant, non-lactating female between 18 and 55 years of age (inclusive). * Body Mass Index (BMI) between 18 and 32 kg/m² (inclusive). * Non-smoking/non-vaping, healthy, with no history of clinically relevant medical illness. Key
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 Fredericia's formula (QTcF) prolongation over 450 milliseconds at Screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Maximum Concentration [T(max)] of PBI-200 | 7 days | Tmax will be determined from the observed plasma concentration data. |
| Area Under the Concentration-Time Curve (AUC) of PBI-200 from time zero to the time of the last measurable concentration [AUC(0-t)] | 7 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)] | 7 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 of the maximum observed drug concentration [T(max)] | 7 days | Time of the maximum observed drug concentration |
| Terminal elimination half-life [T(1/2)] | 7 days | Apparent terminal elimination half-life, calculated as ln(2)/ kel. |
Countries
United States
Outcome results
None listed