Trials / Completed
CompletedNCT02019394
Absolute Bioavailability of Lu AE58054 in Healthy Subjects
Interventional, Open-label Study Investigating the Absolute Bioavailability of Lu AE58054 After Multiple Oral Dosing and a Single Radio-labelled Intravenous Micro-dose as Well as the Contribution of Cytochrome P450 2D6 to the Exposure of Lu AE58054 in Healthy Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 10 (actual)
- Sponsor
- H. Lundbeck A/S · Industry
- Sex
- All
- Age
- 21 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
To determine the absolute bioavailability of the Lu AE58054 tablet formulation at steady state
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lu AE58054 | Oral dosing: 90 mg Lu AE58054 as a single dose once and after a 3 days washout period, once daily for 7 days. Intravenous dosing: 90 μg/not more than (NMT) 1000 nCi/37 kBq 14C-Lu AE58054 for intravenous infusion once on Day 10. |
Timeline
- Start date
- 2013-12-01
- Primary completion
- 2014-02-01
- First posted
- 2013-12-24
- Last updated
- 2014-03-21
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT02019394. Inclusion in this directory is not an endorsement.