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

Primary Purpose

Atrial Fibrillation

Status

Completed

Phase

Phase 1

Locations

United Kingdom

Study Type

Interventional

Intervention

10mg XEN-D0103

Placebo

30mg XEN-D0103

60mg XEN-D0103

120mg XEN-D0103

200mg XEN-D0103

150mg XEN-D0103

About this trial

This is an interventional treatment trial for Atrial Fibrillation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

ICON Development Solutions

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm Type

Experimental

Arm Label

Part 1: Single Ascending Dose - Cohort 1

Part 1: Single Ascending Dose - Cohort 2

Part 1: Single Ascending Dose - Cohort 3

Part 1: Single Ascending Dose - Cohort 4

Part 1: Single Ascending Dose - Cohort 5

Part 2: Fed-Fasted

Part 3: Multiple Ascending Dose - Cohort 1

Part 3: Multiple Ascending Dose - Cohort 2

Part 3: Multiple Ascending Dose - Cohort 3

Arm Description

8 subjects (6 receiving 10mg XEN-D0103, 2 receiving placebo)

8 subjects (6 receiving 30mg XEN-D0103, 2 receiving placebo)

8 subjects (6 receiving 60mg XEN-D0103, 2 receiving placebo)

8 subjects (6 receiving 120mg XEN-D0103, 2 receiving placebo)

8 subjects (6 receiving 200mg XEN-D0103, 2 receiving placebo)

17 subjects receiving 200mg XEN-D0103 with either a high fat meal or following an overnight fast.

10 subjects (8 receiving 30mg XEN-D0103 twice daily, 2 receiving placebo twice daily)

10 subjects (8 receiving 60mg XEN-D0103 twice daily, 2 receiving placebo twice daily)

10 subjects (8 receiving 150mg XEN-D0103 once daily, 2 receiving placebo once daily)

Outcomes

Primary Outcome Measures

Number of adverse events

Secondary Outcome Measures

Area Under Curve (AUC) of XEN-D0103 following single and multiple dose administration

Food effect on AUC of XEN-D0103

Change in QTcF with XEN-D0103 and with placebo

Full Information

NCT ID

NCT02390258

First Posted

March 11, 2015

Last Updated

March 17, 2015

Sponsor

Xention Ltd

1. Study Identification

Unique Protocol Identification Number

NCT02390258

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

March 2015

Overall Recruitment Status

Completed

Study Start Date

July 2011 (undefined)

Primary Completion Date

December 2011 (Actual)

Study Completion Date

December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Xention Ltd

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atrial Fibrillation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

87 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Part 1: Single Ascending Dose - Cohort 1

Arm Type

Experimental

Arm Description

8 subjects (6 receiving 10mg XEN-D0103, 2 receiving placebo)

Arm Title

Part 1: Single Ascending Dose - Cohort 2

Arm Type

Experimental

Arm Description

8 subjects (6 receiving 30mg XEN-D0103, 2 receiving placebo)

Arm Title

Part 1: Single Ascending Dose - Cohort 3

Arm Type

Experimental

Arm Description

8 subjects (6 receiving 60mg XEN-D0103, 2 receiving placebo)

Arm Title

Part 1: Single Ascending Dose - Cohort 4

Arm Type

Experimental

Arm Description

8 subjects (6 receiving 120mg XEN-D0103, 2 receiving placebo)

Arm Title

Part 1: Single Ascending Dose - Cohort 5

Arm Type

Experimental

Arm Description

8 subjects (6 receiving 200mg XEN-D0103, 2 receiving placebo)

Arm Title

Part 2: Fed-Fasted

Arm Type

Experimental

Arm Description

17 subjects receiving 200mg XEN-D0103 with either a high fat meal or following an overnight fast.

Arm Title

Part 3: Multiple Ascending Dose - Cohort 1

Arm Type

Experimental

Arm Description

10 subjects (8 receiving 30mg XEN-D0103 twice daily, 2 receiving placebo twice daily)

Arm Title

Part 3: Multiple Ascending Dose - Cohort 2

Arm Type

Experimental

Arm Description

10 subjects (8 receiving 60mg XEN-D0103 twice daily, 2 receiving placebo twice daily)

Arm Title

Part 3: Multiple Ascending Dose - Cohort 3

Arm Type

Experimental

Arm Description

10 subjects (8 receiving 150mg XEN-D0103 once daily, 2 receiving placebo once daily)

Intervention Type

Drug

Intervention Name(s)

10mg XEN-D0103

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Type

Drug

Intervention Name(s)

30mg XEN-D0103

Intervention Type

Drug

Intervention Name(s)

60mg XEN-D0103

Intervention Type

Drug

Intervention Name(s)

120mg XEN-D0103

Intervention Type

Drug

Intervention Name(s)

200mg XEN-D0103

Intervention Type

Drug

Intervention Name(s)

150mg XEN-D0103

Primary Outcome Measure Information:

Title

Number of adverse events

Time Frame

Part 1: 13 days; Part 2: 13 days; Part 3: 22 days

Secondary Outcome Measure Information:

Title

Area Under Curve (AUC) of XEN-D0103 following single and multiple dose administration

Time Frame

Part 1: 13 days; Part 3: 22 days

Title

Food effect on AUC of XEN-D0103

Time Frame

13 days

Title

Change in QTcF with XEN-D0103 and with placebo

Time Frame

2 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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.

Facility Information:

Facility Name

ICON Development Solutions

City

Manchester

ZIP/Postal Code

M15 6SH

Country

United Kingdom

12. IPD Sharing Statement

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

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