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

March 17, 2015 updated by: Xention Ltd

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

87

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Manchester, United Kingdom, M15 6SH
        • ICON Development Solutions

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part 1: Single Ascending Dose - Cohort 1
8 subjects (6 receiving 10mg XEN-D0103, 2 receiving placebo)
Drug: Placebo
Drug: 10mg XEN-D0103
Experimental: Part 1: Single Ascending Dose - Cohort 2
8 subjects (6 receiving 30mg XEN-D0103, 2 receiving placebo)
Drug: Placebo
Drug: 30mg XEN-D0103
Experimental: Part 1: Single Ascending Dose - Cohort 3
8 subjects (6 receiving 60mg XEN-D0103, 2 receiving placebo)
Drug: Placebo
Drug: 60mg XEN-D0103
Experimental: Part 1: Single Ascending Dose - Cohort 4
8 subjects (6 receiving 120mg XEN-D0103, 2 receiving placebo)
Drug: Placebo
Drug: 120mg XEN-D0103
Experimental: Part 1: Single Ascending Dose - Cohort 5
8 subjects (6 receiving 200mg XEN-D0103, 2 receiving placebo)
Drug: Placebo
Drug: 200mg XEN-D0103
Experimental: Part 2: Fed-Fasted
17 subjects receiving 200mg XEN-D0103 with either a high fat meal or following an overnight fast.
Drug: 200mg XEN-D0103
Experimental: Part 3: Multiple Ascending Dose - Cohort 1
10 subjects (8 receiving 30mg XEN-D0103 twice daily, 2 receiving placebo twice daily)
Drug: Placebo
Drug: 30mg XEN-D0103
Experimental: Part 3: Multiple Ascending Dose - Cohort 2
10 subjects (8 receiving 60mg XEN-D0103 twice daily, 2 receiving placebo twice daily)
Drug: Placebo
Drug: 60mg XEN-D0103
Experimental: Part 3: Multiple Ascending Dose - Cohort 3
10 subjects (8 receiving 150mg XEN-D0103 once daily, 2 receiving placebo once daily)
Drug: Placebo
Drug: 150mg XEN-D0103

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of adverse events
Time Frame: Part 1: 13 days; Part 2: 13 days; Part 3: 22 days
Part 1: 13 days; Part 2: 13 days; Part 3: 22 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Area Under Curve (AUC) of XEN-D0103 following single and multiple dose administration
Time Frame: Part 1: 13 days; Part 3: 22 days
Part 1: 13 days; Part 3: 22 days
Food effect on AUC of XEN-D0103
Time Frame: 13 days
13 days
Change in QTcF with XEN-D0103 and with placebo
Time Frame: 2 days
2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xention Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

March 11, 2015

First Submitted That Met QC Criteria

March 11, 2015

First Posted (Estimate)

March 17, 2015

Study Record Updates

Last Update Posted (Estimate)

March 18, 2015

Last Update Submitted That Met QC Criteria

March 17, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XEN-D0103-CL-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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