A Study to Assess the Effect of Food on the Absorption and Bioavailability of PBI-200
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Fasted Study drug will be administered with water, after an overnight fast. |
Drug: PBI-200
Single dose of PBI-200
|
| Experimental: Low-fat Meal Study drug will be administered with water, after an overnight fast, after which time a standard low-fat breakfast will be given. |
Drug: PBI-200
Single dose of PBI-200
|
| Experimental: High-fat Meal Study drug will be administered with water, after an overnight fast, after which time a standard high-fat breakfast will be given. |
Drug: PBI-200
Single dose of PBI-200
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
Eligibility Criteria
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.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Bio-Kinetic Clinical Applications | Springfield | Missouri | United States | 65802 |
Sponsors and Collaborators
- Pyramid Biosciences
Investigators
- Study Director: Chief Medical Officer, Pyramid Biosciences
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PBI-200-103