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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04581772
• Other study ID #: DNLI-F-0002
• Status: Completed
• Phase: Phase 1
• Start date: December 23, 2020
• Est. completion date: June 4, 2021

Study information

• Verified date: June 2021
• Source: Denali Therapeutics Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: June 4, 2021
• Est. primary completion date: June 4, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• DNL343
Multiple oral doses
• Placebo
Single oral dose
• DNL343
Single oral dose

Locations

Country	Name	City	State
New Zealand	Auckland Clinical Studies Ltd.	Grafton	Auckland

Sponsors (1)

Lead Sponsor	Collaborator
Denali Therapeutics Inc.

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PK parameter: Maximum observed concentration (Cmax) of DNL343 in plasma		Up to 15 days
Primary	PK parameter: Time to maximum observed concentration (Tmax) of DNL343 in plasma		Up to 15 days
Primary	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
Primary	PK parameter: The area under the concentration-time curve from time zero extrapolated to infinity (AUC0-8) of DNL343 in plasma		Up to 15 days
Secondary	PK parameter: Maximum observed concentration (Cmax) of DNL343 in plasma in the fed versus fasted states		Up to 15 days
Secondary	PK parameter: Time to maximum observed concentration (Tmax) of DNL343 in plasma in the fed versus fasted states		Up to 15 days
Secondary	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
Secondary	PK parameter: The area under the concentration-time curve from time zero extrapolated to infinity (AUC0-8) of DNL343 in plasma in the fed versus fasted states		Up to 15 days
Secondary	Incidence of treatment-emergent adverse events (TEAEs)		Up to 15 days