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

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ClinicalTrials.gov Identifier: NCT04581772
Recruitment Status : Recruiting
First Posted : October 9, 2020
Last Update Posted : January 25, 2021
Sponsor:
Information provided by (Responsible Party):
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.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 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 Subjects
Actual Study Start Date : December 23, 2020
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

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




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 ]


Information from the National Library of Medicine

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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

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. Recruiting
Grafton, Auckland, New Zealand
Contact: Study Coordinator    + 64 9 373 3474      
Sponsors and Collaborators
Denali Therapeutics Inc.
Investigators
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Study Director: Richard Tsai, MD Denali Therapeutics Inc.
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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: January 25, 2021
Last Verified: January 2021

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