NCT02112903

Brief Summary

The purpose of this study is to evaluate the gastro-intestinal tolerability (nausea, vomiting, diarrhoea, abdominal discomfort, and abdominal pain) of vortioxetine following single oral doses of three modified-release (MR) capsules with differently coated multiple particles compared to one immediate-release (IR) tablet.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

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

April 1, 2014

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

April 10, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 14, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Last Updated

November 13, 2014

Status Verified

November 1, 2014

Enrollment Period

5 months

First QC Date

April 10, 2014

Last Update Submit

November 12, 2014

Conditions

Healthy Women

Outcome Measures

Primary Outcomes (7)

  • Gastro-intestinal tolerability (nausea) measured with 11-point Numerical Rating Scale

    Up to 24 hours post-dose in each treatment period

  • Gastro-intestinal tolerability (abdominal pain) measured with 11-point Numerical Rating Scale

    Up to 24 hours post-dose in each treatment period

  • Gastro-intestinal tolerability (abdominal discomfort) measured with 11-point Numerical Rating Scale

    Up to 24 hours post-dose in each treatment period

  • Frequency, severity and duration of reported gastro-intestinal tolerability (nausea, vomiting, diarrhoea, abdominal discomfort and abdominal pain)

    Up to 72 hours post-dose in each treatment period

  • Area under the vortioxetine plasma concentration-time curve from zero to 72 hours post-dose (AUC0-72h)

    Up to 72 hours postdose

  • Maximum observed concentration (Cmax) of vortioxetine

    Up to 72 hours postdose

  • Nominal time corresponding to the occurrence of Cmax (tmax)

    Up to 72 hours postdose

Study Arms (4)

Encapsulated vortioxetine IR tablet, 20 mg

EXPERIMENTAL

Single oral dose

Drug: Encapsulated vortioxetine IR tablet, 20 mg

Vortioxetine MR capsule 20 mg (pH 5.5)

EXPERIMENTAL

Single oral dose

Drug: Vortioxetine MR capsule 20 mg (pH 5.5)

Vortioxetine MR capsule 20 mg (pH 6.0)

EXPERIMENTAL

Single oral dose

Drug: Vortioxetine MR capsule 20 mg (pH 6.0)

Vortioxetine MR capsule 20 mg (pH 7.0)

EXPERIMENTAL

Single oral dose

Drug: Vortioxetine MR capsule 20 mg (pH 7.0)

Interventions

Encapsulated vortioxetine IR tablet, 20 mgDRUG
Encapsulated vortioxetine IR tablet, 20 mg
Vortioxetine MR capsule 20 mg (pH 5.5)DRUG
Vortioxetine MR capsule 20 mg (pH 5.5)
Vortioxetine MR capsule 20 mg (pH 6.0)DRUG
Vortioxetine MR capsule 20 mg (pH 6.0)
Vortioxetine MR capsule 20 mg (pH 7.0)DRUG
Vortioxetine MR capsule 20 mg (pH 7.0)

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy women ≥18 and ≤45 years of age with a body mass index (BMI) of \>18.5 and \<30.0 kg/m2.
  • Women will be of child-bearing potential with a confirmed non-pregnant and non-lactating status.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GB801

London, NW10 7EW, United Kingdom

Location

Study Officials

  • Email contact via H. Lundbeck A/S

    LundbeckClinicalTrials@lundbeck.com

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2014

First Posted

April 14, 2014

Study Start

April 1, 2014

Primary Completion

September 1, 2014

Last Updated

November 13, 2014

Record last verified: 2014-11

Locations

GB(1)