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

Phase 1

Completed

• Conditions: Healthy Women
• Interventions: Drug: Encapsulated vortioxetine IR tablet, 20 mg; Drug: Vortioxetine MR capsule 20 mg (pH 5.5); Drug: Vortioxetine MR capsule 20 mg (pH 7.0); Drug: Vortioxetine MR capsule 20 mg (pH 6.0)

• Registration Number: NCT02112903
• Lead Sponsor: H. Lundbeck A/S

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-04-10
• Study First Submitted QC: 2014-04-11
• Study First Posted: 2014-04-14
• Primary Completion: 2014-09
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-12
• Last Update Posted: 2014-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Encapsulated vortioxetine IR tablet, 20 mg	Encapsulated vortioxetine IR tablet, 20 mg	Single oral dose
Vortioxetine MR capsule 20 mg (pH 5.5)	Vortioxetine MR capsule 20 mg (pH 5.5)	Single oral dose
Vortioxetine MR capsule 20 mg (pH 7.0)	Vortioxetine MR capsule 20 mg (pH 7.0)	Single oral dose
Vortioxetine MR capsule 20 mg (pH 6.0)	Vortioxetine MR capsule 20 mg (pH 6.0)	Single oral dose

Primary Outcome Measures

Name	Time	Method
Nominal time corresponding to the occurrence of Cmax (tmax)	Up to 72 hours postdose
Maximum observed concentration (Cmax) of vortioxetine	Up to 72 hours postdose
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
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

Trial Locations

Locations (1)

GB801; 🇬🇧 London, United Kingdom