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Absolute Bioavailability of Lu AE58054 in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
H. Lundbeck A/S
ClinicalTrials.gov Identifier:
NCT02019394
First received: December 18, 2013
Last updated: March 20, 2014
Last verified: March 2014
  Purpose
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: Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]
    Intravenous (IV)

  • Ratio of (AUC0-24(PM)/AUC0-24(EM)) [ Time Frame: Day 10 ] [ Designated as safety issue: No ]
    Poor Metaboliser (PM); Extensive Metaboliser (EM)


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

  • Number of subjects with adverse events [ Time Frame: Up to Day 16 ] [ Designated as safety issue: Yes ]
    Adverse event monitoring

  • Risk of Suicidality [ Time Frame: Up to Day 16 ] [ Designated as safety issue: Yes ]
    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.


  Eligibility

Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02019394

Locations
United Kingdom
GB803
Nottingham, United Kingdom, NG11 6JS
Sponsors and Collaborators
H. Lundbeck A/S
Investigators
Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com
  More Information

Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT02019394     History of Changes
Other Study ID Numbers: 14915A  2012-005646-37 
Study First Received: December 18, 2013
Last Updated: March 20, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

ClinicalTrials.gov processed this record on December 09, 2016