Fed-Fasted, Single and Multiple Ascending Dose Trial of XEN-D0103
Phase 1
Completed
- Conditions
- Atrial Fibrillation
- Interventions
- Drug: PlaceboDrug: 10mg XEN-D0103Drug: 200mg XEN-D0103Drug: 30mg XEN-D0103Drug: 60mg XEN-D0103Drug: 120mg XEN-D0103Drug: 150mg XEN-D0103
- Registration Number
- NCT02390258
- Lead Sponsor
- Xention Ltd
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 87
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Part 3: Multiple Ascending Dose - Cohort 3 Placebo 10 subjects (8 receiving 150mg XEN-D0103 once daily, 2 receiving placebo once daily) Part 1: Single Ascending Dose - Cohort 1 Placebo 8 subjects (6 receiving 10mg XEN-D0103, 2 receiving placebo) Part 1: Single Ascending Dose - Cohort 2 30mg XEN-D0103 8 subjects (6 receiving 30mg XEN-D0103, 2 receiving placebo) Part 1: Single Ascending Dose - Cohort 5 Placebo 8 subjects (6 receiving 200mg XEN-D0103, 2 receiving placebo) Part 3: Multiple Ascending Dose - Cohort 1 30mg XEN-D0103 10 subjects (8 receiving 30mg XEN-D0103 twice daily, 2 receiving placebo twice daily) Part 1: Single Ascending Dose - Cohort 1 10mg XEN-D0103 8 subjects (6 receiving 10mg XEN-D0103, 2 receiving placebo) Part 1: Single Ascending Dose - Cohort 3 Placebo 8 subjects (6 receiving 60mg XEN-D0103, 2 receiving placebo) Part 1: Single Ascending Dose - Cohort 3 60mg XEN-D0103 8 subjects (6 receiving 60mg XEN-D0103, 2 receiving placebo) Part 1: Single Ascending Dose - Cohort 4 Placebo 8 subjects (6 receiving 120mg XEN-D0103, 2 receiving placebo) Part 2: Fed-Fasted 200mg XEN-D0103 17 subjects receiving 200mg XEN-D0103 with either a high fat meal or following an overnight fast. Part 3: Multiple Ascending Dose - Cohort 1 Placebo 10 subjects (8 receiving 30mg XEN-D0103 twice daily, 2 receiving placebo twice daily) Part 1: Single Ascending Dose - Cohort 2 Placebo 8 subjects (6 receiving 30mg XEN-D0103, 2 receiving placebo) Part 1: Single Ascending Dose - Cohort 4 120mg XEN-D0103 8 subjects (6 receiving 120mg XEN-D0103, 2 receiving placebo) Part 1: Single Ascending Dose - Cohort 5 200mg XEN-D0103 8 subjects (6 receiving 200mg XEN-D0103, 2 receiving placebo) Part 3: Multiple Ascending Dose - Cohort 3 150mg XEN-D0103 10 subjects (8 receiving 150mg XEN-D0103 once daily, 2 receiving placebo once daily) Part 3: Multiple Ascending Dose - Cohort 2 Placebo 10 subjects (8 receiving 60mg XEN-D0103 twice daily, 2 receiving placebo twice daily) Part 3: Multiple Ascending Dose - Cohort 2 60mg XEN-D0103 10 subjects (8 receiving 60mg XEN-D0103 twice daily, 2 receiving placebo twice daily)
- Primary Outcome Measures
Name Time Method Number of adverse events Part 1: 13 days; Part 2: 13 days; Part 3: 22 days
- Secondary Outcome Measures
Name Time Method Change in QTcF with XEN-D0103 and with placebo 2 days Area Under Curve (AUC) of XEN-D0103 following single and multiple dose administration Part 1: 13 days; Part 3: 22 days Food effect on AUC of XEN-D0103 13 days
Trial Locations
- Locations (1)
ICON Development Solutions
🇬🇧Manchester, United Kingdom
ICON Development Solutions🇬🇧Manchester, United Kingdom