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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04557800
• Other study ID #: DNLI-C-0001
• Secondary ID: 2017-003730-82
• Status: Completed
• Phase: Phase 1
• Start date: November 16, 2017
• Est. completion date: February 19, 2021

Study information

• Verified date: February 2022
• 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 ascending dose (SAD), multiple ascending dose (MAD), and 28-day safety study of orally administered DNL151 in healthy volunteers.

Description:

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.).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 186
• Est. completion date: February 19, 2021
• Est. primary completion date: February 19, 2021
• 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:
• DNL151
oral dose(s)
• Placebo
oral dose(s)

Locations

Country	Name	City	State
Netherlands	PRA Health Sciences, Van Swietenlaan	Groningen
Netherlands	Centre for Human Drug Research	Leiden	South Holland

Sponsors (1)

Lead Sponsor	Collaborator
Denali Therapeutics Inc.

Country where clinical trial is conducted

Netherlands, 

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 42 days
Primary	PK parameter: Maximum observed concentration (Cmax) of DNL151 in plasma		Up to 42 days
Primary	PK parameter: Time to maximum observed concentration (Tmax) of DNL151 in plasma		Up to 42 days
Primary	PK parameter: The area under the concentration-time curve from time zero extrapolated to infinity (AUC0-8) of DNL151 in plasma (single dosing only)		Up to 42 days
Primary	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		Up to 42 days
Primary	PK parameter: The area under the concentration-time curve over a dosing interval (AUC0-t) of DNL151 in plasma (multiple dosing only)		Up to 42 days
Primary	PK parameter: Apparent terminal elimination half-life (t1/2) of DNL151 in plasma		Up to 42 days
Secondary	Concentration of DNL151 in cerebrospinal fluid (CSF) (following selected single and multiple doses)		Up to 13 days
Secondary	The pharmacodynamics of DNL151 in whole blood as measured by the percent change from baseline in pS935		Up to 42 days