Trial | NCT04551534  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    DNL201 ...

  • Study Participants

    122
This is a Phase 1, randomized, double-blind, placebo-controlled, single- and multiple-ascending oral dose study conducted in three parts.
Study Started
Jun 01
2017
Primary Completion
Aug 08
2018
Study Completion
Aug 08
2018
Last Update
Sep 16
2020

Drug DNL201

Oral dose(s)

Drug Placebo

Oral dose(s)

DNL201 Experimental

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

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)

Criteria 

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
No Results Posted