NCT02199431

Brief Summary

The purpose of this study is to evaluate the increase in exposure of Lu AF11167 following a single oral dose of Lu AF11167 with and without administration of multiple oral doses of itraconazole (a strong CYP3A4/5 inhibitor) in healthy subjects with inferred metabolic status as CYP2C19 extensive metabolisers

Trial Health

80
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at P25-P50 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

July 1, 2014

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

July 23, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 24, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Last Updated

September 21, 2015

Status Verified

September 1, 2015

Enrollment Period

7 months

First QC Date

July 23, 2014

Last Update Submit

September 18, 2015

Conditions

Healthy

Keywords

Lu AF11167Interaction

Outcome Measures

Primary Outcomes (2)

  • Area under the Lu AF11167 plasma concentration-time curve from zero to infinity (AUC0-inf)

    Day 1 and 8

  • Maximum observed plasma concentration (Cmax) of Lu AF11167

    Day 1 and 8

Secondary Outcomes (2)

  • Area under the Lu AF36201 plasma concentration-time curve from zero to infinity (AUC0-inf)

    Day 1 and 8

  • Maximum observed plasma concentration (Cmax) of Lu AF36201

    Day 1 and 8

Study Arms (2)

Lu AF1167 capsule 0.5 mg

EXPERIMENTAL

Single oral dose (day 1)

Drug: Lu AF11167

Lu AF11167 0.5 mg capsule + itraconazole 200 mg capsule

EXPERIMENTAL

Itraconazole administered once daily for 7 days (day 3-9); Lu AF11167 administered as a single dose on day 8

Drug: Lu AF11167Drug: Itraconazole

Interventions

Lu AF11167DRUG
Lu AF11167 0.5 mg capsule + itraconazole 200 mg capsuleLu AF1167 capsule 0.5 mg
ItraconazoleDRUG
Lu AF11167 0.5 mg capsule + itraconazole 200 mg capsule

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Subjects be 18 years of age and 55 years of age and with a BMI \>18.5 kg/m2 and \<30.0 kg/m2 at the Screening Visit. Women must not be pregnant or lactating.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Covance

Leeds, United Kingdom

Location

MeSH Terms

Interventions

Itraconazole

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPiperazines

Study Officials

  • Email contact via H. Lundbeck A/S

    LundbeckClinicalTrials@Lundbeck.com

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2014

First Posted

July 24, 2014

Study Start

July 1, 2014

Primary Completion

February 1, 2015

Last Updated

September 21, 2015

Record last verified: 2015-09

Locations

GB(1)