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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. completion date
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


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
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