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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04551534
• Other study ID #: DNLI-B-0001
• Status: Completed
• Phase: Phase 1
• Start date: June 1, 2017
• Est. completion date: August 8, 2018

Study information

• Verified date: September 2020
• Source: Denali Therapeutics Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: August 8, 2018
• Est. primary completion date: August 8, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• DNL201
Oral dose(s)
• Placebo
Oral dose(s)

Locations

Country	Name	City	State
United States	Clinical Site(s)	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Denali Therapeutics Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of treatment-emergent adverse events (TEAEs) including serious adverse events (SAEs), and discontinuations due to TEAEs		Up to 20 days
Primary	PK parameter: Maximum observed concentration (Cmax) of DNL201 in plasma		Up to 10 days
Primary	PK parameter: Time to maximum observed concentration (Tmax) of DNL201 in plasma		Up to 10 days
Primary	PK parameter: The area under the concentration-time curve from time zero extrapolated to infinity (AUC0-8) of DNL201 in plasma (single dosing only)		Up to 10 days
Primary	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
Primary	PK parameter: The area under the concentration-time curve over a dosing interval (AUC0-t) of DNL201 in plasma (multiple dosing only)		Up to 10 days
Primary	PK parameter: Apparent terminal elimination half-life (t1/2) of DNL201 in plasma		Up to 10 days
Secondary	Concentration of DNL201 in cerebrospinal fluid (CSF) (following selected single and multiple doses)		Up to 10 days
Secondary	The pharmacodynamics of DNL201 in whole blood as measured by the percent change from baseline in pS935		Up to 10 days