A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL919 in Healthy Participants

Healthy Participant Clinical Trial

Official title:

A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL919 in Healthy Participants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05450549
• Other study ID #: DNLI-G-0001
• Secondary ID: 2022-000756-10
• Status: Completed
• Phase: Phase 1
• Start date: July 14, 2022
• Est. completion date: June 8, 2023

Study information

• Verified date: August 2023
• 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) study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of DNL919.

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: 47
• Est. completion date: June 8, 2023
• Est. primary completion date: June 8, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Key Inclusion Criteria:

• Female participants of non-childbearing potential (surgically sterilized or post menopausal) or male participants, aged 18 to 55 years, inclusive

• BMI 18.5 to <30 kg/m²

• When engaging in sex with a woman of child bearing potential, both the male participant and his female partner must use highly effective contraception

Key Exclusion Criteria:

• History of clinically significant neurologic, psychiatric, endocrine, pulmonary, cardiovascular, gastrointestinal, hepatic, pancreatic, renal, metabolic, hematologic, immunologic, or allergic disease, or other major disorders

• History of malignancy

• History of clinically significant stroke

• History of cognitive impairment

• Positive serum pregnancy test at screening, positive urine pregnancy test at baseline visit, or currently lactating or breastfeeding

Related Conditions & MeSH terms

• Healthy Participant

Intervention

Drug:
• DNL919
Single doses
• Placebo
Single doses

Locations

Country	Name	City	State
Netherlands	Centre for Human Drug Research (CHDR)	Leiden	South Holland

Sponsors (2)

Lead Sponsor	Collaborator
Denali Therapeutics Inc.	Takeda

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety: Incidence, severity, and seriousness of treatment-emergent adverse events (TEAEs)		Up to 45 days
Secondary	PK Parameter: Maximum concentration (Cmax) of DNL919 in serum		Up to 45 days
Secondary	PK Parameter: Area under the concentration-time curve from time zero to infinity (AUCinf)		Up to 45 days