Trials / Completed
CompletedNCT04581772
A Study to Evaluate the Bioavailability and Safety of DNL343 in Healthy Volunteers
A Phase 1 Open-Label, Randomized, Crossover Study to Evaluate the Bioavailability, Effect of Food, Palatability, and Safety of Various DNL343 Oral Formulations in Healthy Participants
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 31 (actual)
- Sponsor
- Denali Therapeutics Inc. · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | DNL343 | Multiple oral doses |
| DRUG | Placebo | Single oral dose |
| DRUG | DNL343 | Single oral dose |
Timeline
- Start date
- 2020-12-23
- Primary completion
- 2021-06-04
- Completion
- 2021-06-04
- First posted
- 2020-10-09
- Last updated
- 2021-06-11
Locations
1 site across 1 country: New Zealand
Source: ClinicalTrials.gov record NCT04581772. Inclusion in this directory is not an endorsement.