Study Comparing the Gastro-intestinal Tolerability and Absorption Profile of Vortioxetine After Administration of Modified-release Formulations and Immediate-release Formulation in Healthy Women

Interventional, Randomised, Double-blind 4-way Crossover Study Comparing the Gastro-intestinal Tolerability and Absorption Profile of Vortioxetine After Administration of Modified-release Formulations and Immediate-release Formulation in Healthy Women

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.

Study Overview

• Status: Completed
• Conditions: Healthy Women
• Intervention / Treatment: Drug: Encapsulated vortioxetine IR tablet, 20 mg; Drug: Vortioxetine MR capsule 20 mg (pH 5.5); Drug: Vortioxetine MR capsule 20 mg (pH 6.0); Drug: Vortioxetine MR capsule 20 mg (pH 7.0)

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, NW10 7EW
    • GB801

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 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.

Other protocol-defined Inclusion and Exclusion Criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Encapsulated vortioxetine IR tablet, 20 mg; Single oral dose	Drug: Encapsulated vortioxetine IR tablet, 20 mg
Experimental: Vortioxetine MR capsule 20 mg (pH 5.5); Single oral dose	Drug: Vortioxetine MR capsule 20 mg (pH 5.5)
Experimental: Vortioxetine MR capsule 20 mg (pH 6.0); Single oral dose	Drug: Vortioxetine MR capsule 20 mg (pH 6.0)
Experimental: Vortioxetine MR capsule 20 mg (pH 7.0); Single oral dose	Drug: Vortioxetine MR capsule 20 mg (pH 7.0)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: H. Lundbeck A/S

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: April 10, 2014
• First Submitted That Met QC Criteria: April 11, 2014
• First Posted (Estimate): April 14, 2014

Study Record Updates

• Last Update Posted (Estimate): November 13, 2014
• Last Update Submitted That Met QC Criteria: November 12, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Tranquilizing Agents; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Serotonin 5-HT1 Receptor Agonists; Serotonin Receptor Agonists; Serotonin Antagonists; Anti-Anxiety Agents; Serotonin 5-HT3 Receptor Antagonists; Vortioxetine
• Other Study ID Numbers: 15947A; 2014-000121-20 (EudraCT Number)