Atrial FibrillationPhase 1NCT02390258
Fed-Fasted, Single and Multiple Ascending Dose Trial of XEN-D0103
A Phase 1 study testing 10mg XEN-D0103, 30mg XEN-D0103 and 60mg XEN-D0103 in people with Atrial Fibrillation, run by Xention Ltd at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- 10mg XEN-D0103, 30mg XEN-D0103 and 60mg XEN-D0103
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 87 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2011to Dec 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Centre, Randomised, Double-blind, Placebo-controlled, Fed-fasted, Single and Multiple Ascending Dose Trial of XEN-D0103 in Healthy Subjects
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
- Being tested
- 10mg XEN-D0103, Placebo, 30mg XEN-D0103, 60mg XEN-D0103, 120mg XEN-D0103
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10mg XEN-D0103Drug
PlaceboDrug
30mg XEN-D0103Drug
60mg XEN-D0103Drug
120mg XEN-D0103Drug
200mg XEN-D0103Drug
150mg XEN-D0103Drug
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Single Ascending Dose - Cohort 1 | Experimental | 8 subjects (6 receiving 10mg XEN-D0103, 2 receiving placebo) Receives: Drug: 10mg XEN-D0103; Drug: Placebo |
| Part 1: Single Ascending Dose - Cohort 2 | Experimental | 8 subjects (6 receiving 30mg XEN-D0103, 2 receiving placebo) Receives: Drug: Placebo; Drug: 30mg XEN-D0103 |
| Part 1: Single Ascending Dose - Cohort 3 | Experimental | 8 subjects (6 receiving 60mg XEN-D0103, 2 receiving placebo) Receives: Drug: Placebo; Drug: 60mg XEN-D0103 |
| Part 1: Single Ascending Dose - Cohort 4 | Experimental | 8 subjects (6 receiving 120mg XEN-D0103, 2 receiving placebo) Receives: Drug: Placebo; Drug: 120mg XEN-D0103 |
| Part 1: Single Ascending Dose - Cohort 5 | Experimental | 8 subjects (6 receiving 200mg XEN-D0103, 2 receiving placebo) Receives: 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. Receives: 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) Receives: 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) Receives: 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) Receives: Drug: Placebo; Drug: 150mg XEN-D0103 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events
Measured: 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
Measured: Part 1: 13 days; Part 3: 22 days
Food effect on AUC of XEN-D0103
Measured: 13 days
Change in QTcF with XEN-D0103 and with placebo
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2015 (estimated)
- Study startJul 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xention Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02390258
- Sponsor's protocol ID
- XEN-D0103-CL-01
- Status last verified
- Mar 2015
- First submitted
- 11 Mar 2015
- Last updated
- 18 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Centre, Randomised, Double-blind, Placebo-controlled, Fed-fasted, Single and Multiple Ascending Dose Trial of XEN-D0103 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02390258
- Acronym / sponsor ID
- XEN-D0103-CL-01
- Conditions
- Atrial Fibrillation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Xention LtdIndustry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 17 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Part 1: Single Ascending Dose - Cohort 1 | Experimental | Drug: 10mg XEN-D0103, Drug: Placebo8 subjects (6 receiving 10mg XEN-D0103, 2 receiving placebo) |
| Part 1: Single Ascending Dose - Cohort 2 | Experimental | Drug: Placebo, Drug: 30mg XEN-D01038 subjects (6 receiving 30mg XEN-D0103, 2 receiving placebo) |
| Part 1: Single Ascending Dose - Cohort 3 | Experimental | Drug: Placebo, Drug: 60mg XEN-D01038 subjects (6 receiving 60mg XEN-D0103, 2 receiving placebo) |
| Part 1: Single Ascending Dose - Cohort 4 | Experimental | Drug: Placebo, Drug: 120mg XEN-D01038 subjects (6 receiving 120mg XEN-D0103, 2 receiving placebo) |
| Part 1: Single Ascending Dose - Cohort 5 | Experimental | Drug: Placebo, Drug: 200mg XEN-D01038 subjects (6 receiving 200mg XEN-D0103, 2 receiving placebo) |
| Part 2: Fed-Fasted | Experimental | Drug: 200mg XEN-D010317 subjects receiving 200mg XEN-D0103 with either a high fat meal or following an overnight fast. |
| Part 3: Multiple Ascending Dose - Cohort 1 | Experimental | Drug: Placebo, Drug: 30mg XEN-D010310 subjects (8 receiving 30mg XEN-D0103 twice daily, 2 receiving placebo twice daily) |
| Part 3: Multiple Ascending Dose - Cohort 2 | Experimental | Drug: Placebo, Drug: 60mg XEN-D010310 subjects (8 receiving 60mg XEN-D0103 twice daily, 2 receiving placebo twice daily) |
| Part 3: Multiple Ascending Dose - Cohort 3 | Experimental | Drug: Placebo, Drug: 150mg XEN-D010310 subjects (8 receiving 150mg XEN-D0103 once daily, 2 receiving placebo once daily) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 |
Primary outcome
Number of adverse events
Time frame: Part 1: 13 days; Part 2: 13 days; Part 3: 22 days
3 secondary outcomes
Area Under Curve (AUC) of XEN-D0103 following single and multiple dose administration
Time frame: Part 1: 13 days; Part 3: 22 days
Food effect on AUC of XEN-D0103
Time frame: 13 days
Change in QTcF with XEN-D0103 and with placebo
Time frame: 2 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2015.
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 10mg XEN-D0103, 30mg XEN-D0103 and 60mg XEN-D0103 in people with Atrial Fibrillation, run by Xention Ltd at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of adverse events (time frame: Part 1: 13 days; Part 2: 13 days; Part 3: 22 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2015.