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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02019394

Enrollment

Registered

2013-12-24

Start date

2013-12-31

Completion date

Unknown

Last updated

2014-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

To determine the absolute bioavailability of the Lu AE58054 tablet formulation at steady state

Interventions

DRUGLu 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy men and women aged between 21-55 years (inclusive) and with an BMI in the range 18.5 to 32 kg/m2 (minimum weight 60 kg for men and 55 kg for women). * The subjects CYP2D6 genotype must be determined before inclusion into the study. * Women must not be pregnant or lactating.

Exclusion criteria

* The subject is, in the opinion of the investigator, unlikely to comply with the protocol or is unsuitable for any reason. Other inclusion and

Design outcomes

Primary

Measure	Time frame	Description
Absolute bioavailability: (AUC0-24) Dose oral/(AUC0-inf) Dose IV	Day 10	Intravenous (IV)
Ratio of (AUC0-24(PM)/AUC0-24(EM))	Day 10	Poor Metaboliser (PM); Extensive Metaboliser (EM)

Secondary

Measure	Time frame	Description
Number and frequency of adverse events	Up to Day 16	Standard clinical safety assessments
Number of subjects with adverse events	Up to Day 16	Adverse event monitoring
Risk of Suicidality	Up to Day 16	Columbia Suicide Severity Rating Scale (C-SSRS) categorisation based on Columbia Classification Algorithm of Suicide Assessment (C-CASA) definitions

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026