NCT02019394

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

December 18, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 24, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Last Updated

March 21, 2014

Status Verified

March 1, 2014

Enrollment Period

2 months

First QC Date

December 18, 2013

Last Update Submit

March 20, 2014

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • Number and frequency of adverse events

    Up to Day 16

  • Number of subjects with adverse events

    Up to Day 16

  • Risk of Suicidality

    Up to Day 16

Study Arms (1)

Lu AE58054

EXPERIMENTAL
Drug: Lu AE58054

Interventions

Lu AE58054DRUG

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.

Lu AE58054

Eligibility Criteria

Age21 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).
  • Women must not be pregnant or lactating.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GB803

Nottingham, NG11 6JS, United Kingdom

Location

MeSH Terms

Interventions

(2-(6-fluoro-1H-indol-3-yl)-ethyl)-(3-(2,2,3,3-tetrafluoropropoxy)benzyl)amine

Study Officials

  • Email contact via H. Lundbeck A/S

    LundbeckClinicalTrials@lundbeck.com

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 18, 2013

First Posted

December 24, 2013

Study Start

December 1, 2013

Primary Completion

February 1, 2014

Last Updated

March 21, 2014

Record last verified: 2014-03

Locations

GB(1)