Skip to main content
OpenTrials
Completed

NCT Number: NCT06281158

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Site

Madison, Wisconsin, 53704, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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  • Have previously completed or withdrawn from this study or any other study investigating DNL343 and have previously received DNL343

Treatment and study plan

[14C]-DNL343

Drug

Single dose

Primary outcomes

  1. PK Parameter: AUC0-∞

    Time frame: 28 days

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

  2. PK Parameter: AUC0-tlast

    Time frame: 28 days

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

  3. PK Parameter: Cmax

    Time frame: 28 days

    Maximum observed concentration (Cmax) of DNL343 in plasma

  4. PK Parameter: Tmax

    Time frame: 28 days

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

  5. PK Parameter: t1/2

    Time frame: 28 days

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

  6. Total radioactivity in plasma and whole blood

    Time frame: 28 days

  7. Total radioactivity in blood-to-plasma ratio

    Time frame: 28 days

  8. Extent and rate of recovery of total radioactivity in urine and feces

    Time frame: 28 days

Secondary outcomes

  1. PK Parameter: AUC0-∞

    Time frame: 28 days

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

  2. PK Parameter: AUC0-tlast

    Time frame: 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

  3. PK Parameter: Cmax

    Time frame: 28 days

    Maximum observed concentration (Cmax) of a DNL343 metabolite in plasma

  4. PK Parameter: Tmax

    Time frame: 28 days

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

  5. PK Parameter: t1/2

    Time frame: 28 days

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

  6. DNL343 and a DNL343 metabolite recoveries in urine

    Time frame: 28 days

  7. Incidence, severity, and seriousness of treatment-emergent adverse events (TEAEs)

    Time frame: 28 days

Sponsors and collaborators

Lead sponsor

Denali Therapeutics Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 28, 2024
Registry last updated
Jun 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.