A Study to Evaluate the Bioavailability and Safety of DNL343 in Healthy Volunteers

A Phase 1 Open-Label, Randomized, Crossover Study to Evaluate the Bioavailability, Effect of Food, Palatability, and Safety of Various DNL343 Oral Formulations in Healthy Participants

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04581772

Enrollment

Registered

2020-10-09

Start date

2020-12-23

Completion date

2021-06-04

Last updated

2021-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Brief summary

This is a Phase 1 relative bioavailability study carried out in approximately 24 healthy male subjects and healthy female subjects of non childbearing potential to investigate the effects of formulation and food on the safety, tolerability, and pharmacokinetics (PK) of DNL343.

Interventions

DRUGDNL343

Multiple oral doses

DRUGPlacebo

Single oral dose

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

Key Inclusion Criteria: * Body mass index (BMI) ≥18.5 to \< 30 kg/m2 and body weight of at least 50 kg * For women: Must have been surgically sterilized or be postmenopausal. Key

Exclusion criteria

* History of clinically significant endocrine, pulmonary, cardiovascular, gastrointestinal, hepatic, pancreatic, renal, metabolic, hematologic, immunologic, or allergic disease, or other major disorders * History of malignancy, except fully resected basal cell carcinoma * History of clinically significant neurologic or psychiatric diseases; head trauma with loss of consciousness; or clinically significant depression or suicidal ideation

Design outcomes

Primary

Measure	Time frame
PK parameter: Maximum observed concentration (Cmax) of DNL343 in plasma	Up to 15 days
PK parameter: Time to maximum observed concentration (Tmax) of DNL343 in plasma	Up to 15 days
PK Parameter: Area under the concentration-time curve from time zero to the last quantifiable time point (AUC0-t) of DNL343 in plasma	Up to 15 days
PK parameter: The area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞) of DNL343 in plasma	Up to 15 days

Secondary

Measure	Time frame
PK parameter: Maximum observed concentration (Cmax) of DNL343 in plasma in the fed versus fasted states	Up to 15 days
Incidence of treatment-emergent adverse events (TEAEs)	Up to 15 days
PK parameter: Time to maximum observed concentration (Tmax) of DNL343 in plasma in the fed versus fasted states	Up to 15 days
PK Parameter: Area under the concentration-time curve from time zero to the last quantifiable time point (AUC0-t) of DNL343 in plasma in the fed versus fasted states	Up to 15 days
PK parameter: The area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞) of DNL343 in plasma in the fed versus fasted states	Up to 15 days

Countries

New Zealand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026