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Trial record 1 of 12 for:    Lu AE58054
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Absolute Bioavailability of Lu AE58054 in Healthy Subjects

This study has been completed.
Information provided by (Responsible Party):
H. Lundbeck A/S Identifier:
First received: December 18, 2013
Last updated: March 20, 2014
Last verified: March 2014
To determine the absolute bioavailability of the Lu AE58054 tablet formulation at steady state

Condition Intervention Phase
Healthy Drug: Lu AE58054 Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: 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

Further study details as provided by H. Lundbeck A/S:

Primary Outcome Measures:
  • Absolute bioavailability: (AUC0-24) Dose oral/(AUC0-inf) Dose IV [ Time Frame: Day 10 ]
    Intravenous (IV)

  • Ratio of (AUC0-24(PM)/AUC0-24(EM)) [ Time Frame: Day 10 ]
    Poor Metaboliser (PM); Extensive Metaboliser (EM)

Secondary Outcome Measures:
  • Number and frequency of adverse events [ Time Frame: Up to Day 16 ]
    Standard clinical safety assessments

  • Number of subjects with adverse events [ Time Frame: Up to Day 16 ]
    Adverse event monitoring

  • Risk of Suicidality [ Time Frame: Up to Day 16 ]
    Columbia Suicide Severity Rating Scale (C-SSRS) categorisation based on Columbia Classification Algorithm of Suicide Assessment (C-CASA) definitions

Enrollment: 10
Study Start Date: December 2013
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts 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 exclusion criteria may apply.

  Contacts and Locations
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Please refer to this study by its identifier: NCT02019394

United Kingdom
Nottingham, United Kingdom, NG11 6JS
Sponsors and Collaborators
H. Lundbeck A/S
Study Director: Email contact via H. Lundbeck A/S
  More Information

Responsible Party: H. Lundbeck A/S Identifier: NCT02019394     History of Changes
Other Study ID Numbers: 14915A
2012-005646-37 ( EudraCT Number )
Study First Received: December 18, 2013
Last Updated: March 20, 2014 processed this record on August 18, 2017