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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04581772
Recruitment Status : Completed
First Posted : October 9, 2020
Last Update Posted : June 11, 2021
Sponsor:
Information provided by (Responsible Party):
Denali Therapeutics Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: DNL343 Drug: Placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : December 23, 2020
Actual Primary Completion Date : June 4, 2021
Actual Study Completion Date : June 4, 2021
Arms and Interventions
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Arm Intervention/treatment
Experimental: Cohort A Drug: DNL343
Multiple oral doses

Drug: Placebo
Single oral dose
Experimental: Cohort B Drug: DNL343
Multiple oral doses

Drug: Placebo
Single oral dose
Experimental: Cohort C Drug: DNL343
Single oral dose


Outcome Measures
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Primary Outcome Measures :
  1. PK parameter: Maximum observed concentration (Cmax) of DNL343 in plasma [ Time Frame: Up to 15 days ]
  2. PK parameter: Time to maximum observed concentration (Tmax) of DNL343 in plasma [ Time Frame: Up to 15 days ]
  3. 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 ]
  4. 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 ]

Secondary Outcome Measures :
  1. PK parameter: Maximum observed concentration (Cmax) of DNL343 in plasma in the fed versus fasted states [ Time Frame: Up to 15 days ]
  2. PK parameter: Time to maximum observed concentration (Tmax) of DNL343 in plasma in the fed versus fasted states [ Time Frame: Up to 15 days ]
  3. 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 ]
  4. 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 ]
  5. Incidence of treatment-emergent adverse events (TEAEs) [ Time Frame: Up to 15 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04581772


Locations
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New Zealand
Auckland Clinical Studies Ltd.
Grafton, Auckland, New Zealand
Sponsors and Collaborators
Denali Therapeutics Inc.
Investigators
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Study Director: Richard Tsai, MD Denali Therapeutics Inc.
More Information
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Responsible Party: Denali Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT04581772    
Other Study ID Numbers: DNLI-F-0002
First Posted: October 9, 2020    Key Record Dates
Last Update Posted: June 11, 2021
Last Verified: June 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No