A Phase 1 Study of the Absorption, Metabolism, and Excretion of [14C] PBI-200
Phase 1
Completed
- Conditions
- Absorption, Metabolism and Excretion in Healthy Volunteers
- Interventions
- Drug: [14C]-PBI-200
- Registration Number
- NCT05238337
- Lead Sponsor
- Pyramid Biosciences
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 6
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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description [14C]-PBI-200 Treated [14C]-PBI-200 \[14C\]-labeled PBI-200 will be administered as a single dose
- Primary Outcome Measures
Name Time Method Ratio for AUC(0-inf) Blood / Plasma 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 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 Maximum Observed Concentration [C(max)] 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 Ratio for AUC(0-inf) Plasma PBI-200 / Total Radioactivity 28 days
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Labcorp Clinical Research Unit Inc
🇺🇸Madison, Wisconsin, United States