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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06281158
• Other study ID #: DNLI-F-0009
• Status: Completed
• Phase: Phase 1
• Start date: March 1, 2024
• Est. completion date: April 30, 2024

Study information

• Verified date: June 2024
• Source: Denali Therapeutics Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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• Have previously completed or withdrawn from this study or any other study investigating DNL343 and have previously received DNL343

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• [14C]-DNL343
Single dose

Locations

Country	Name	City	State
United States	Clinical Site	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Denali Therapeutics Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PK Parameter: AUC0-8	The area under the concentration-time curve from time zero extrapolated to infinity (AUC0-8) of DNL343 in plasma	28 days
Primary	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
Primary	PK Parameter: Cmax	Maximum observed concentration (Cmax) of DNL343 in plasma	28 days
Primary	PK Parameter: Tmax	Time to maximum observed concentration (Tmax) of DNL343 in plasma	28 days
Primary	PK Parameter: t1/2	Terminal elimination half-life (t1/2) of DNL343 in plasma	28 days
Primary	Total radioactivity in plasma and whole blood		28 days
Primary	Total radioactivity in blood-to-plasma ratio		28 days
Primary	Extent and rate of recovery of total radioactivity in urine and feces		28 days
Secondary	PK Parameter: AUC0-8	The area under the concentration-time curve from time zero extrapolated to infinity (AUC0-8) of a DNL343 metabolite in plasma	28 days
Secondary	PK Parameter: AUC0-tlast	Area under the concentration-time curve from time zero to the last quantifiable time point (AUC0-tlast) of a DNL343 metabolite in plasma	28 days
Secondary	PK Parameter: Cmax	Maximum observed concentration (Cmax) of a DNL343 metabolite in plasma	28 days
Secondary	PK Parameter: Tmax	Time to maximum observed concentration (Tmax) of a DNL343 metabolite in plasma	28 days
Secondary	PK Parameter: t1/2	Terminal elimination half-life (t1/2) of a DNL343 metabolite in plasma	28 days
Secondary	DNL343 and a DNL343 metabolite recoveries in urine		28 days
Secondary	Incidence, severity, and seriousness of treatment-emergent adverse events (TEAEs)		28 days