A Study of the Pharmacokinetics of [14C]-DNL343 Following a Single Oral Dose in Healthy Male Participants

DNLI-F-0009

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

2024-03-01

2024-05-01

2024-05-01

Recruiting

Early phase I

7

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that would potentially alter absorption and/or excretion of orally administered drugs * Have previously completed or withdrawn from this study or any other study investigating DNL343 and have previously received DNL343

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 7, 'type': 'ESTIMATED'}}

2024-03-01