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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy Women

Intervention / Treatment
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* 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)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |