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OpenTrials
Completed

NCT Number: NCT02019394

Absolute Bioavailability of Lu AE58054 in Healthy Subjects

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

Completed

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Key information

Conditions

Healthy

Age range

21 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

GB803

Nottingham, NG11 6JS, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lu AE58054

Drug

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.

Primary outcomes

  1. Absolute bioavailability: (AUC0-24) Dose oral/(AUC0-inf) Dose IV

    Time frame: Day 10

    Intravenous (IV)

  2. Ratio of (AUC0-24(PM)/AUC0-24(EM))

    Time frame: Day 10

    Poor Metaboliser (PM); Extensive Metaboliser (EM)

Secondary outcomes

  1. Number and frequency of adverse events

    Time frame: Up to Day 16

    Standard clinical safety assessments

  2. Number of subjects with adverse events

    Time frame: Up to Day 16

    Adverse event monitoring

  3. 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

Sponsors and collaborators

Lead sponsor

H. Lundbeck A/S

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
First posted
Dec 24, 2013
Registry last updated
Mar 21, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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