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Completed

NCT Number: NCT04551534

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL201 in Healthy Volunteers

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

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Key information

Conditions

Healthy Volunteers

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Site(s)

Dallas, Texas, 05247, United States

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

DNL201

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 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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Denali Therapeutics Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 16, 2020
Registry last updated
Sep 16, 2020

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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