A Study of Absorption, Metabolism, Excretion of [14C]-NS-580 in Healthy Male Subjects

Nippon Shinyaku

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: [14C] NS-580

Study type

Interventional

Funder types

Industry

Identifiers

NCT06670898

NS580-P1-06

Details and patient eligibility

About

The purpose of this study was to determine the absorption, metabolism, and excretion of radioactivity and to characterize and determine, where possible, the metabolites present in plasma, urine, and faeces in healthy male subjects following a single oral administration of [14C]-NS-580.

Enrollment

8 patients

Sex

Male

Ages

35 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Males of any race, between 35 and 60 years of age, inclusive.
Body mass index between 18.0 and 32.0 kg/m2, inclusive.
History of a minimum of 1 bowel movement per day.

Exclusion criteria

Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, haematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator (or designee).
History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator (or designee).