A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-DNL343 Following a Single Oral Dose in Healthy Male Participants

Denali Therapeutics

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: [14C]-DNL343

Study type

Interventional

Funder types

Industry

Identifiers

NCT06281158

DNLI-F-0009

Details and patient eligibility

About

This is a Phase 1, open-label, nonrandomized, single-dose study in healthy male participants to investigate the absorption, metabolism and excretion of DNL343.

Enrollment

7 patients

Sex

Male

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Males, aged between 18 to 65 years, inclusive
Body mass index between 18.0 and 32.0 kg/m2
In good health
When engaging in sex with a woman of child bearing potential, both the male participant and his female partner must use highly effective contraception
History of a minimum of 1 bowel movement per day

Exclusion criteria

History or clinical manifestation of any clinically significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder
Have a history of malignancy, except fully resected basal cell carcinoma
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
Have previously completed or withdrawn from this study or any other study investigating DNL343 and have previously received DNL343