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A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL201 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: NCT04551534
Recruitment Status : Completed
First Posted : September 16, 2020
Last Update Posted : September 16, 2020
Sponsor:
Information provided by (Responsible Party):
Denali Therapeutics Inc.

Brief Summary:
This is a Phase 1, randomized, double-blind, placebo-controlled, single- and multiple-ascending oral dose study conducted in three parts.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: DNL201 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 122 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A First-In-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Oral Doses of DNL201 in Healthy Subjects
Actual Study Start Date : June 1, 2017
Actual Primary Completion Date : August 8, 2018
Actual Study Completion Date : August 8, 2018

Arm Intervention/treatment
Experimental: DNL201
Part 1: Single-ascending dose cohorts; Part 2: Multiple-ascending dose cohorts (10 days); Part 3: Additional multiple-dose cohort (10 days)
Drug: DNL201
Oral dose(s)

Placebo Comparator: Placebo
Part 1: Single-ascending dose cohorts; Part 2: Multiple-ascending dose cohorts (10 days); Part 3: Additional multiple-dose cohort (10 days)
Drug: Placebo
Oral dose(s)




Primary Outcome Measures :
  1. Incidence of treatment-emergent adverse events (TEAEs) including serious adverse events (SAEs), and discontinuations due to TEAEs [ Time Frame: Up to 20 days ]
  2. PK parameter: Maximum observed concentration (Cmax) of DNL201 in plasma [ Time Frame: Up to 10 days ]
  3. PK parameter: Time to maximum observed concentration (Tmax) of DNL201 in plasma [ Time Frame: Up to 10 days ]
  4. PK parameter: The area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞) of DNL201 in plasma (single dosing only) [ Time Frame: Up to 10 days ]
  5. PK parameter: Area under the concentration-time curve from time zero to the time of last quantifiable concentration (AUC[0-last]) of DNL201 in plasma [ Time Frame: Up to 10 days ]
  6. PK parameter: The area under the concentration-time curve over a dosing interval (AUC0-τ) of DNL201 in plasma (multiple dosing only) [ Time Frame: Up to 10 days ]
  7. PK parameter: Apparent terminal elimination half-life (t1/2) of DNL201 in plasma [ Time Frame: Up to 10 days ]

Secondary Outcome Measures :
  1. Concentration of DNL201 in cerebrospinal fluid (CSF) (following selected single and multiple doses) [ Time Frame: Up to 10 days ]
  2. The pharmacodynamics of DNL201 in whole blood as measured by the percent change from baseline in pS935 [ Time Frame: Up to 10 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Key Inclusion Criteria:

  • Body mass index 18.5 to 35.0 kg/m², inclusive, and body weight of at least 50.0 kg at screening
  • In good health, determined by no clinically significant findings from medical history, physical examination, and vital sign measurements
  • Women of non-childbearing potential and men using contraceptive measures

Key Exclusion Criteria:

  • History of clinically significant hematological, renal, pancreatic, gastrointestinal, hepatic, cardiovascular, metabolic, endocrine, immunological, allergic disease, or other major disorders
  • History of asthma, chronic obstructive pulmonary disease, or emphysema
  • Clinically significant neurologic disorder
  • History of stomach or intestinal surgery or resection
  • History of malignancy

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): NCT04551534


Locations
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United States, Texas
Clinical Site(s)
Dallas, Texas, United States, 05247
Sponsors and Collaborators
Denali Therapeutics Inc.
Investigators
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Study Director: Danna Jennings, MD Denali Therapeutics Inc.
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Responsible Party: Denali Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT04551534    
Other Study ID Numbers: DNLI-B-0001
First Posted: September 16, 2020    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: September 2020

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