Trials / Completed
CompletedNCT04082325
Study Investigating the Safety and Tolerability of Lu AF88434 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 AF88434 and Open-label Crossover Study to Investigate the Intra-individual Variability, Metabolic Profile, and Effect of Food on Lu AF88434 in Healthy Young Men
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 68 (actual)
- Sponsor
- H. Lundbeck A/S · Industry
- Sex
- Male
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
This study evaluates the effect of Lu AF88434 on the body and what the body does to Lu AF88434 and the effect of food after swallowing single oral doses
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lu AF88434 | Lu AF88434, single oral solution Starting dose will be 0.2 mg, actual doses for following cohorts will be defined based on results from preceding dosing group(s). |
| DRUG | Lu AF99722 14C spiked dosage ([14C]-radiolabelled Lu AF88434) | Oral solution |
| DRUG | Lu AF99723 14C spiked dosage ([14C]-radiolabelled Lu AF88434) | Oral solution |
| DRUG | Placebo | Placebo to Lu AF88434 oral solution, single dose |
Timeline
- Start date
- 2019-07-23
- Primary completion
- 2020-09-24
- Completion
- 2020-09-24
- First posted
- 2019-09-09
- Last updated
- 2021-02-24
Locations
1 site across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT04082325. Inclusion in this directory is not an endorsement.