Clinical trial NCT05160389: A Study to Assess the Effect of Food on the Absorption and Bioavailability of PBI-200
Official title: A Single-Dose, Open-Label, Randomized, Three-Way, Crossover Study to Assess the Effect of Food on the Absorption and Bioavailability of PBI-200 in Normal Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Food Effect in Healthy Volunteers
Keywords: Volunteer
Lead sponsor: Pyramid Biosciences
Sponsor class: INDUSTRY
First posted: 2021-12-16
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Single-dose, open-label, randomized, three-way crossover design
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Time to Maximum Concentration [T(max)] of PBI-200
timeFrame: 7 days
measure: Area Under the Concentration-Time Curve (AUC) of PBI-200 from time zero to the time of the last measurable concentration [AUC(0-t)]
timeFrame: 7 days
measure: AUC of PBI-200 from time zero to infinity [AUC(0-inf)]
timeFrame: 7 days
Secondary outcomes:
measure: Time of the maximum observed drug concentration [T(max)]
timeFrame: 7 days
measure: Terminal elimination half-life [T(1/2)]
timeFrame: 7 days
Other outcomes:
Locations:
city: Springfield
country: United States
facility: Bio-Kinetic Clinical Applications
state: Missouri
Study officials:
affiliation: Pyramid Biosciences
name: Chief Medical Officer
role: STUDY_DIRECTOR
References: