A Phase 1 Study of the Absorption, Metabolism, and Excretion of [14C] PBI-200

Pyramid Biosciences

Status and phase

Completed

Phase 1

Conditions

Absorption, Metabolism and Excretion in Healthy Volunteers

Treatments

Drug: [14C]-PBI-200

Study type

Interventional

Funder types

Industry

Identifiers

NCT05238337

PBI-200-104

Details and patient eligibility

About

This is a Phase 1, open-label non-randomized, single dose study in healthy male subjects.

Full 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

Enrollment

6 patients

Sex

Male

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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).