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

NCT06281158 | Completed Phase 1 FDA Drug

• 1 other identifier: DNLI-F-0009
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (8)

• PK Parameter: AUC0-∞

  The area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞) of DNL343 in plasma

  28 days

• PK Parameter: AUC0-tlast

  Area under the concentration-time curve from time zero to the last quantifiable time point (AUC0-tlast) of DNL343 in plasma

  28 days

• PK Parameter: Cmax

  Maximum observed concentration (Cmax) of DNL343 in plasma

  28 days

• PK Parameter: Tmax

  Time to maximum observed concentration (Tmax) of DNL343 in plasma

  28 days

• PK Parameter: t1/2

  Terminal elimination half-life (t1/2) of DNL343 in plasma

  28 days

• Total radioactivity in plasma and whole blood

  28 days

• Total radioactivity in blood-to-plasma ratio

  28 days

• Extent and rate of recovery of total radioactivity in urine and feces

  28 days

Secondary Outcomes (7)

• PK Parameter: AUC0-∞

  28 days

• PK Parameter: AUC0-tlast

  28 days

• PK Parameter: Cmax

  28 days

• PK Parameter: Tmax

  28 days

• PK Parameter: t1/2

  28 days

Study Arms (1)

14C-DNL343

EXPERIMENTAL

Drug: [14C]-DNL343

Interventions

[14C]-DNL343 DRUG

Single dose

14C-DNL343

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Denali Therapeutics Inc.: lead

Study Sites (1)

Clinical Site

Madison, Wisconsin, 53704, United States

Location

Study Officials

• Ana-Claire Meyer, MD

  Denali Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2024
• First Posted: February 28, 2024
• Study Start: March 1, 2024
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: June 20, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)