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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: [14C]-DNL343

• Registration Number: NCT06281158
• Lead Sponsor: Denali Therapeutics Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-20
• Study First Submitted QC: 2024-02-26
• Study First Posted: 2024-02-28
• Study Start: 2024-03-01
• Primary Completion: 2024-04-30
• Study Completion: 2024-04-30
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-17
• Last Update Posted: 2024-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 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

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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• Have previously completed or withdrawn from this study or any other study investigating DNL343 and have previously received DNL343

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
14C-DNL343	[14C]-DNL343	-

Primary Outcome Measures

Name	Time	Method
PK Parameter: AUC0-∞	28 days	The area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞) of DNL343 in plasma
Total radioactivity in blood-to-plasma ratio	28 days
PK Parameter: Cmax	28 days	Maximum observed concentration (Cmax) of DNL343 in plasma
PK Parameter: t1/2	28 days	Terminal elimination half-life (t1/2) of DNL343 in plasma
Total radioactivity in plasma and whole blood	28 days
Extent and rate of recovery of total radioactivity in urine and feces	28 days
PK Parameter: AUC0-tlast	28 days	Area under the concentration-time curve from time zero to the last quantifiable time point (AUC0-tlast) of DNL343 in plasma
PK Parameter: Tmax	28 days	Time to maximum observed concentration (Tmax) of DNL343 in plasma

Secondary Outcome Measures

Name	Time	Method
PK Parameter: AUC0-∞	28 days	The area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞) of a DNL343 metabolite in plasma
PK Parameter: Cmax	28 days	Maximum observed concentration (Cmax) of a DNL343 metabolite in plasma
DNL343 and a DNL343 metabolite recoveries in urine	28 days
PK Parameter: t1/2	28 days	Terminal elimination half-life (t1/2) of a DNL343 metabolite in plasma
PK Parameter: Tmax	28 days	Time to maximum observed concentration (Tmax) of a DNL343 metabolite in plasma
PK Parameter: AUC0-tlast	28 days	Area under the concentration-time curve from time zero to the last quantifiable time point (AUC0-tlast) of a DNL343 metabolite in plasma
Incidence, severity, and seriousness of treatment-emergent adverse events (TEAEs)	28 days

Trial Locations

Locations (1)

Clinical Site; 🇺🇸 Madison, Wisconsin, United States