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

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ClinicalTrials.gov Identifier: NCT02390258
Recruitment Status : Completed
First Posted : March 17, 2015
Last Update Posted : March 18, 2015
Sponsor:
Information provided by (Responsible Party):
Xention Ltd

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Drug: 10mg XEN-D0103 Drug: Placebo Drug: 30mg XEN-D0103 Drug: 60mg XEN-D0103 Drug: 120mg XEN-D0103 Drug: 200mg XEN-D0103 Drug: 150mg XEN-D0103 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 87 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Single Centre, Randomised, Double-blind, Placebo-controlled, Fed-fasted, Single and Multiple Ascending Dose Trial of XEN-D0103 in Healthy Subjects
Study Start Date : July 2011
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Part 1: Single Ascending Dose - Cohort 1
8 subjects (6 receiving 10mg XEN-D0103, 2 receiving placebo)
 Drug: 10mg XEN-D0103
Drug: Placebo
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


Outcome Measures
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Primary Outcome Measures :
  1. Number of adverse events [ Time Frame: Part 1: 13 days; Part 2: 13 days; Part 3: 22 days ]

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02390258


Locations
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United Kingdom
ICON Development Solutions
Manchester, United Kingdom, M15 6SH
Sponsors and Collaborators
Xention Ltd
More Information
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Responsible Party: Xention Ltd
ClinicalTrials.gov Identifier: NCT02390258    
Other Study ID Numbers: XEN-D0103-CL-01
First Posted: March 17, 2015    Key Record Dates
Last Update Posted: March 18, 2015
Last Verified: March 2015
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
 S66913
Potassium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action