Status:
COMPLETED
A Phase 1 Study of the Absorption, Metabolism, and Excretion of [14C] PBI-200
Lead Sponsor:
Pyramid Biosciences
Conditions:
Absorption, Metabolism and Excretion in Healthy Volunteers
Eligibility:
MALE
18-65 years
Phase:
PHASE1
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
Eligibility Criteria
Inclusion
- Key
- 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
- 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).
Key Trial Info
Start Date :
February 24 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 24 2022
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT05238337
Start Date
February 24 2022
End Date
March 24 2022
Last Update
August 30 2022
Active Locations (1)
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1
Labcorp Clinical Research Unit Inc
Madison, Wisconsin, United States, 53704