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

June 10, 2021 updated by: Denali Therapeutics Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • New Zealand
    • Auckland
      • Grafton, Auckland, New Zealand
        • Auckland Clinical Studies Ltd.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 53 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort B
Drug: Placebo
Single oral dose
Drug: DNL343
Multiple oral doses
Drug: DNL343
Single oral dose
Experimental: Cohort A
Drug: Placebo
Single oral dose
Drug: DNL343
Multiple oral doses
Drug: DNL343
Single oral dose
Experimental: Cohort C
Drug: DNL343
Multiple oral doses
Drug: DNL343
Single oral dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
PK parameter: Maximum observed concentration (Cmax) of DNL343 in plasma
Time Frame: Up to 15 days
Up to 15 days
PK parameter: Time to maximum observed concentration (Tmax) of DNL343 in plasma
Time Frame: Up to 15 days
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
Time Frame: Up to 15 days
Up to 15 days
PK parameter: The area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞) of DNL343 in plasma
Time Frame: Up to 15 days
Up to 15 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Denali Therapeutics Inc.

Investigators

  • Study Director: Richard Tsai, MD, Denali Therapeutics Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 23, 2020

Primary Completion (Actual)

June 4, 2021

Study Completion (Actual)

June 4, 2021

Study Registration Dates

First Submitted

September 29, 2020

First Submitted That Met QC Criteria

October 5, 2020

First Posted (Actual)

October 9, 2020

Study Record Updates

Last Update Posted (Actual)

June 11, 2021

Last Update Submitted That Met QC Criteria

June 10, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • DNLI-F-0002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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