Absorption, Metabolism and Excretion in Healthy Volunteers
Conditions
Brief summary
This is a Phase 1, open-label non-randomized, single dose study in healthy male subjects.
Detailed description
This is a Phase 1, open-label nonrandomized, single dose study in healthy male subjects to determine the absorption, metabolism, and excretion (AME) of \[14C\]-PBI-200
Interventions
DRUG[14C]-PBI-200
\[14C\]-radio-labeled-PBI-200
Sponsors
Pyramid Biosciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Key Inclusion Criteria: * Males, of any race, 18 to 65 years of age as of the dosing day. * Body mass index between 18.0 and 32.0 kg/m2, inclusive. * Non-smoking/non-vaping, healthy, with no history of clinically relevant medical illness. Key
Exclusion criteria
* Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder. * History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance. * History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total Radioactivity in Urine and Feces | 28 days |
| Area Under the Concentration-Time Curve (AUC) of PBI-200 from time zero to infinity [AUC(0-inf)] | 28 days |
| Area Under the Concentration-Time Curve (AUC) of PBI-200 from time zero to the time of the last quantifiable concentration [AUC(0-tlast) | 28 days |
| Maximum Observed Concentration [C(max)] | 28 days |
| Time to Maximum Concentration [T(max)] | 28 days |
| Apparent Terminal Elimination Half-life [t(1/2)] | 28 days |
| Total Radioactivity in Plasma and Whole Blood | 28 days |
| Ratio for AUC(0-inf) Blood / Plasma | 28 days |
| Ratio for AUC(0-inf) Plasma PBI-200 / Total Radioactivity | 28 days |
Countries
United States
Outcome results
None listed