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

Xention

Status and phase: Completed; Phase 1

Conditions: Atrial Fibrillation

Treatments: Drug: 120mg XEN-D0103; Drug: Placebo; Drug: 30mg XEN-D0103; Drug: 200mg XEN-D0103; Drug: 10mg XEN-D0103; Drug: 60mg XEN-D0103; Drug: 150mg XEN-D0103

Study type: Interventional

Funder types: Industry

Identifiers

NCT02390258

XEN-D0103-CL-01

Details and patient eligibility

About

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.

Enrollment: 87 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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87 participants in 9 patient groups

Part 1: Single Ascending Dose - Cohort 1

Experimental group

Description:

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

Treatment:

Drug: 10mg XEN-D0103

Drug: Placebo

Part 1: Single Ascending Dose - Cohort 2

Experimental group

Description:

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

Treatment:

Drug: 30mg XEN-D0103

Drug: Placebo

Part 1: Single Ascending Dose - Cohort 3

Experimental group

Description:

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

Treatment:

Drug: 60mg XEN-D0103

Drug: Placebo

Part 1: Single Ascending Dose - Cohort 4

Experimental group

Description:

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

Treatment:

Drug: 120mg XEN-D0103

Drug: Placebo

Part 1: Single Ascending Dose - Cohort 5

Experimental group

Description:

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

Treatment:

Drug: 200mg XEN-D0103

Drug: Placebo

Part 2: Fed-Fasted

Experimental group

Description:

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

Treatment:

Drug: 200mg XEN-D0103

Part 3: Multiple Ascending Dose - Cohort 1

Experimental group

Description:

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

Treatment:

Drug: 30mg XEN-D0103

Drug: Placebo

Part 3: Multiple Ascending Dose - Cohort 2

Experimental group

Description:

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

Treatment:

Drug: 60mg XEN-D0103

Drug: Placebo

Part 3: Multiple Ascending Dose - Cohort 3

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: 150mg XEN-D0103