Trial | NCT02390258  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    xen-d0103 ...

  • Study Participants

    87
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 Started
Jul 31
2011
Primary Completion
Dec 31
2011
Study Completion
Dec 31
2011
Last Update
Mar 18
2015
Estimate

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

Part 1: Single Ascending Dose - Cohort 1 Experimental

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

Part 1: Single Ascending Dose - Cohort 2 Experimental

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

Part 1: Single Ascending Dose - Cohort 3 Experimental

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

Part 1: Single Ascending Dose - Cohort 4 Experimental

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

Part 1: Single Ascending Dose - Cohort 5 Experimental

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

Part 2: Fed-Fasted Experimental

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

Part 3: Multiple Ascending Dose - Cohort 1 Experimental

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

Part 3: Multiple Ascending Dose - Cohort 2 Experimental

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

Part 3: Multiple Ascending Dose - Cohort 3 Experimental

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

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.
No Results Posted