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

NCT02390258 | Completed Phase 1 DMC

• 1 other identifier: XEN-D0103-CL-01
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Number of adverse events

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

Secondary Outcomes (3)

• 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

Study Arms (9)

Part 1: Single Ascending Dose - Cohort 1

EXPERIMENTAL

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

Drug: 10mg XEN-D0103; Drug: Placebo

Part 1: Single Ascending Dose - Cohort 2

EXPERIMENTAL

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

Drug: Placebo; Drug: 30mg XEN-D0103

Part 1: Single Ascending Dose - Cohort 3

EXPERIMENTAL

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

Drug: Placebo; Drug: 60mg XEN-D0103

Part 1: Single Ascending Dose - Cohort 4

EXPERIMENTAL

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

Drug: Placebo; Drug: 120mg XEN-D0103

Part 1: Single Ascending Dose - Cohort 5

EXPERIMENTAL

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

Drug: Placebo; Drug: 200mg XEN-D0103

Part 2: Fed-Fasted

EXPERIMENTAL

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

Drug: 200mg XEN-D0103

Part 3: Multiple Ascending Dose - Cohort 1

EXPERIMENTAL

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

Drug: Placebo; Drug: 30mg XEN-D0103

Part 3: Multiple Ascending Dose - Cohort 2

EXPERIMENTAL

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

Drug: Placebo; Drug: 60mg XEN-D0103

Part 3: Multiple Ascending Dose - Cohort 3

EXPERIMENTAL

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

Drug: Placebo; Drug: 150mg XEN-D0103

Interventions

10mg XEN-D0103 DRUG

Part 1: Single Ascending Dose - Cohort 1

Placebo DRUG

Part 1: Single Ascending Dose - Cohort 1; Part 1: Single Ascending Dose - Cohort 2; Part 1: Single Ascending Dose - Cohort 3; Part 1: Single Ascending Dose - Cohort 4; Part 1: Single Ascending Dose - Cohort 5; Part 3: Multiple Ascending Dose - Cohort 1; Part 3: Multiple Ascending Dose - Cohort 2; Part 3: Multiple Ascending Dose - Cohort 3

30mg XEN-D0103 DRUG

Part 1: Single Ascending Dose - Cohort 2; Part 3: Multiple Ascending Dose - Cohort 1

60mg XEN-D0103 DRUG

Part 1: Single Ascending Dose - Cohort 3; Part 3: Multiple Ascending Dose - Cohort 2

120mg XEN-D0103 DRUG

Part 1: Single Ascending Dose - Cohort 4

200mg XEN-D0103 DRUG

Part 1: Single Ascending Dose - Cohort 5; Part 2: Fed-Fasted

150mg XEN-D0103 DRUG

Part 3: Multiple Ascending Dose - Cohort 3

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xention Ltd: lead

Study Sites (1)

ICON Development Solutions

Manchester, M15 6SH, United Kingdom

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

S66913

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2015
• First Posted: March 17, 2015
• Study Start: July 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: March 18, 2015

Record last verified: 2015-03

Locations

GB (1)