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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02390258

Enrollment

Registered

2015-03-17

Start date

2011-07-31

Completion date

2011-12-31

Last updated

2015-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

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.

Interventions

DRUG10mg XEN-D0103

DRUGPlacebo

DRUG30mg XEN-D0103

DRUG60mg XEN-D0103

DRUG120mg XEN-D0103

DRUG200mg XEN-D0103

DRUG150mg XEN-D0103

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Number of adverse events	Part 1: 13 days; Part 2: 13 days; Part 3: 22 days

Secondary

Measure	Time frame
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
Change in QTcF with XEN-D0103 and with placebo	2 days

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026