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

Healthy Women Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02112903
• Other study ID #: 15947A
• Secondary ID: 2014-000121-20
• Status: Completed
• Phase: Phase 1
• First received: April 10, 2014
• Last updated: November 12, 2014
• Start date: April 2014

Study information

• Verified date: November 2014
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Women

Intervention

Drug:
• Encapsulated vortioxetine IR tablet, 20 mg

• Vortioxetine MR capsule 20 mg (pH 5.5)

• Vortioxetine MR capsule 20 mg (pH 6.0)

• Vortioxetine MR capsule 20 mg (pH 7.0)

Locations

Country	Name	City	State
United Kingdom	GB801	London

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gastro-intestinal tolerability (nausea) measured with 11-point Numerical Rating Scale		Up to 24 hours post-dose in each treatment period	Yes
Primary	Gastro-intestinal tolerability (abdominal pain) measured with 11-point Numerical Rating Scale		Up to 24 hours post-dose in each treatment period	Yes
Primary	Gastro-intestinal tolerability (abdominal discomfort) measured with 11-point Numerical Rating Scale		Up to 24 hours post-dose in each treatment period	Yes
Primary	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	Yes
Primary	Area under the vortioxetine plasma concentration-time curve from zero to 72 hours post-dose (AUC0-72h)		Up to 72 hours postdose	No
Primary	Maximum observed concentration (Cmax) of vortioxetine		Up to 72 hours postdose	No
Primary	Nominal time corresponding to the occurrence of Cmax (tmax)		Up to 72 hours postdose	No