Fed-Fasted, Single and Multiple Ascending Dose Trial of XEN-D0103

Atrial Fibrillation Clinical Trial

Official title:

A Single Centre, Randomised, Double-blind, Placebo-controlled, Fed-fasted, Single and Multiple Ascending Dose Trial of XEN-D0103 in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02390258
• Other study ID #: XEN-D0103-CL-01
• Status: Completed
• Phase: Phase 1
• First received: March 11, 2015
• Last updated: March 17, 2015
• Start date: July 2011
• Est. completion date: December 2011

Study information

• Verified date: March 2015
• Source: Xention Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

This study is an evaluation of the safety and tolerability of XEN-D0103 in healthy subjects. Part 1 assesses the safety, tolerability and blood levels of the ascending single doses of XEN-D0103. Blood levels of XEN-D0103 will be assessed when administered with food and also without food in Part 2. The safety, tolerability and blood levels of XEN-D0103 will be assessed following dosing for 10 days in Part 3.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• For Parts 1 and 3 healthy, male subjects aged 18 to 45 years, inclusive. For Part 2 healthy, male and female subjects aged 45 to 65 years, inclusive.

• Females must be of non-childbearing potential

Exclusion Criteria:

• Subject has a known heart disease.

• Subject has any of QTcF > 450 msec, PR = 210 msec or QRS = 120 msec at screening (determined from median of three readings).

• For Part 1 only: subject has resting heart rate outside of the range 45 to 80 beats per minute (bpm) at screening (determined from median of three readings).

• Subject has any other condition which, in the investigator's opinion will interfere with the trial.

• Subject has a systolic blood pressure (BP) <80 or >160 mmHg at screening or a diastolic BP >90 or <45 mmHg at screening.

• Subject has a clinically significant abnormal laboratory test result at screening.

• Female subject who is pregnant or breast feeding and female subjects of childbearing potential.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• 10mg XEN-D0103

• Placebo

• 30mg XEN-D0103

• 60mg XEN-D0103

• 120mg XEN-D0103

• 200mg XEN-D0103

• 150mg XEN-D0103

Locations

Country	Name	City	State
United Kingdom	ICON Development Solutions	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Xention Ltd

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of adverse events		Part 1: 13 days; Part 2: 13 days; Part 3: 22 days	Yes
Secondary	Area Under Curve (AUC) of XEN-D0103 following single and multiple dose administration		Part 1: 13 days; Part 3: 22 days	No
Secondary	Food effect on AUC of XEN-D0103		13 days	No
Secondary	Change in QTcF with XEN-D0103 and with placebo		2 days	No