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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: DNL343; Drug: Placebo

• Registration Number: NCT04581772
• Lead Sponsor: Denali Therapeutics Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-29
• Study First Submitted QC: 2020-10-05
• Study First Posted: 2020-10-09
• Study Start: 2020-12-23
• Status Verified: 2021-06
• Primary Completion: 2021-06-04
• Study Completion: 2021-06-04
• Last Update Submitted: 2021-06-10
• Last Update Posted: 2021-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Cohort B	DNL343	-
Cohort A	Placebo	-
Cohort B	Placebo	-
Cohort A	DNL343	-
Cohort C	DNL343	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
PK parameter: Maximum observed concentration (Cmax) of DNL343 in plasma in the fed versus fasted states	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
Incidence of treatment-emergent adverse events (TEAEs)	Up to 15 days

Trial Locations

Locations (1)

Auckland Clinical Studies Ltd.; 🇳🇿 Grafton, Auckland, New Zealand