NCT04551534

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P75+ for phase_1 healthy-volunteers

Timeline
Completed

Started Jun 2017

Longer than P75 for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 8, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 8, 2018

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

September 10, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 16, 2020

Completed
Last Updated

September 16, 2020

Status Verified

September 1, 2020

Enrollment Period

1.2 years

First QC Date

September 10, 2020

Last Update Submit

September 10, 2020

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (7)

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

    Up to 20 days

  • PK parameter: Maximum observed concentration (Cmax) of DNL201 in plasma

    Up to 10 days

  • PK parameter: Time to maximum observed concentration (Tmax) of DNL201 in plasma

    Up to 10 days

  • PK parameter: The area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞) of DNL201 in plasma (single dosing only)

    Up to 10 days

  • 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

    Up to 10 days

  • PK parameter: The area under the concentration-time curve over a dosing interval (AUC0-τ) of DNL201 in plasma (multiple dosing only)

    Up to 10 days

  • PK parameter: Apparent terminal elimination half-life (t1/2) of DNL201 in plasma

    Up to 10 days

Secondary Outcomes (2)

  • Concentration of DNL201 in cerebrospinal fluid (CSF) (following selected single and multiple doses)

    Up to 10 days

  • The pharmacodynamics of DNL201 in whole blood as measured by the percent change from baseline in pS935

    Up to 10 days

Study Arms (2)

DNL201

EXPERIMENTAL

Part 1: Single-ascending dose cohorts; Part 2: Multiple-ascending dose cohorts (10 days); Part 3: Additional multiple-dose cohort (10 days)

Drug: DNL201

Placebo

PLACEBO COMPARATOR

Part 1: Single-ascending dose cohorts; Part 2: Multiple-ascending dose cohorts (10 days); Part 3: Additional multiple-dose cohort (10 days)

Drug: Placebo

Interventions

DNL201DRUG

Oral dose(s)

DNL201
PlaceboDRUG

Oral dose(s)

Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Site(s)

Dallas, Texas, 05247, United States

Location

Related Publications (1)

  • Joshi D, Kulkarni M, Parekh P, Shah S, Greig NH, Acharya S. Targeting protein kinases in Parkinson's disease: the emerging role of phytoconstituents. Nutr Neurosci. 2025 Dec;28(12):1532-1563. doi: 10.1080/1028415X.2025.2531356. Epub 2025 Jul 18.

    PMID: 40680102DERIVED

MeSH Terms

Interventions

2-methyl-2-(3-methyl-4-((4-(methylamino)-5-(trifluoromethyl)pyrimidin-2-yl)amino)-1H-pyrazol-1-yl)propanenitrile

Study Officials

  • Danna Jennings, MD

    Denali Therapeutics Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2020

First Posted

September 16, 2020

Study Start

June 1, 2017

Primary Completion

August 8, 2018

Study Completion

August 8, 2018

Last Updated

September 16, 2020

Record last verified: 2020-09

Locations

US(1)