Trials / Completed
CompletedNCT05003687
Safety and Tolerability of Lu AG06474 in Healthy Young Men
Interventional, Randomized, Double-Blind, Sequential-Group, Placebo-Controlled, Single-Ascending Oral Dose Study Investigating the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of Lu AG06474 and Open-Label, Cross-Over Study to Investigate Intra-Subject Variability and the Effect of Food in Healthy Young Men
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 79 (actual)
- Sponsor
- H. Lundbeck A/S · Industry
- Sex
- Male
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to investigate the safety and tolerability of Lu AG06474 and what the body does to Lu AG06474 after swallowing single doses of the drug.
Detailed description
Part A: randomized, double-blind, sequential. Part B: randomized, open-label, cross-over.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lu AG06474 | solution, orally (Parts A and B) |
| DRUG | Placebo | solution, orally (Part A only) |
Timeline
- Start date
- 2021-08-04
- Primary completion
- 2022-12-22
- Completion
- 2022-12-22
- First posted
- 2021-08-12
- Last updated
- 2023-01-09
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05003687. Inclusion in this directory is not an endorsement.