MedTrace Logo

A Study to Evaluate the Bioavailability and Safety of DNL343 in Healthy Volunteers

NCT04581772 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2021-06-11

No results posted yet for this study

Summary

This is a Phase 1 relative bioavailability study carried out in approximately 24 healthy male subjects and healthy female subjects of non childbearing potential to investigate the effects of formulation and food on the safety, tolerability, and pharmacokinetics (PK) of DNL343.

Conditions

  • Healthy Volunteers

Interventions

DRUG

DNL343

Multiple oral doses

DRUG

Placebo

Single oral dose

DRUG

DNL343

Single oral dose

Sponsors & Collaborators

  • Denali Therapeutics Inc.

    lead INDUSTRY

Principal Investigators

  • Richard Tsai, MD · Denali Therapeutics Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-12-23
Primary Completion
2021-06-04
Completion
2021-06-04

Countries

  • New Zealand

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04581772 on ClinicalTrials.gov