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OpenTrials
Completed

NCT Number: NCT04557800

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL151 in Healthy Volunteers

This is a Phase 1, randomized, double-blind, placebo-controlled, single ascending dose (SAD), multiple ascending dose (MAD), and 28-day safety study of orally administered DNL151 in healthy volunteers.

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Key information

Conditions

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Centre for Human Drug Research, Leiden, South Holland, Netherlands

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About this study

This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under Section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by Sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DNL151

Drug

oral dose(s)

Placebo

Drug

oral dose(s)

Primary outcomes

  1. Incidence of treatment-emergent adverse events (TEAEs) including serious adverse events (SAEs), and discontinuations due to TEAEs

    Time frame: Up to 42 days

  2. PK parameter: Maximum observed concentration (Cmax) of DNL151 in plasma

    Time frame: Up to 42 days

  3. PK parameter: Time to maximum observed concentration (Tmax) of DNL151 in plasma

    Time frame: Up to 42 days

  4. PK parameter: The area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞) of DNL151 in plasma (single dosing only)

    Time frame: Up to 42 days

  5. PK parameter: Area under the concentration-time curve from time zero to the time of last quantifiable concentration (AUC[0-last]) of DNL151 in plasma

    Time frame: Up to 42 days

  6. PK parameter: The area under the concentration-time curve over a dosing interval (AUC0-τ) of DNL151 in plasma (multiple dosing only)

    Time frame: Up to 42 days

  7. PK parameter: Apparent terminal elimination half-life (t1/2) of DNL151 in plasma

    Time frame: Up to 42 days

Secondary outcomes

  1. Concentration of DNL151 in cerebrospinal fluid (CSF) (following selected single and multiple doses)

    Time frame: Up to 13 days

  2. The pharmacodynamics of DNL151 in whole blood as measured by the percent change from baseline in pS935

    Time frame: Up to 42 days

Sponsors and collaborators

Lead sponsor

Denali Therapeutics Inc.

Industry

Registry information

Official study title

A Phase 1, Randomized, Placebo-Controlled, Double-Blind Study to Determine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Of DNL151 in Healthy Volunteers

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Sep 22, 2020
Registry last updated
Mar 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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