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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Lu AE58054

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Nottingham, United Kingdom, NG11 6JS
    • GB803

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lu AE58054	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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: H. Lundbeck A/S

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: December 18, 2013
• First Submitted That Met QC Criteria: December 18, 2013
• First Posted (Estimate): December 24, 2013

Study Record Updates

• Last Update Posted (Estimate): March 21, 2014
• Last Update Submitted That Met QC Criteria: March 20, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: 14915A; 2012-005646-37 (EudraCT Number)