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Completed

NCT Number: NCT02390258

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

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

ICON Development Solutions

Manchester, M15 6SH, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Drug

Primary outcomes

  1. Number of adverse events

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

Secondary outcomes

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

    Time frame: Part 1: 13 days; Part 3: 22 days

  2. Food effect on AUC of XEN-D0103

    Time frame: 13 days

  3. Change in QTcF with XEN-D0103 and with placebo

    Time frame: 2 days

Sponsors and collaborators

Lead sponsor

Xention Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Mar 17, 2015
Registry last updated
Mar 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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