HealthyPhase 1NCT01552928

Effect of Anagrelide Hydrochloride on Any Changes in Heart Function in Healthy Volunteers

A Phase 1 study testing Anagrelide 0.5 mg, Anagrelide 2.5 mg and Moxifloxacin in people with Healthy, run by Shire at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Anagrelide 0.5 mg, Anagrelide 2.5 mg and Moxifloxacin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 60 participants
Where: 1 siteFrance
Study dates: 29 Mar 2012to 25 Jul 2012
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Age 18-45 years inclusive at the time of consent. The date of signing informed consent is defined as the beginning of the screening period. This inclusion criteria will only be assessed at the screening visit.
Subject is willing to comply with any applicable contraceptive requirements of the protocol and is: male, or non-pregnant non lactating female, or females must be at least 90 days post-partum or nulliparous.
Satisfactory medical assessment with no clinically or relevant abnormalities in medical history, physical examination, vital signs, ECG, and clinical laboratory evaluation as assessed by the investigator.

Who cannot join

Current or recurrent disease that could affect the action, absorption, or disposition of the investigational product, or could affect clinical or laboratory assessments.
a- Current or relevant history of physical or psychiatric illness, any medical disorder that may require treatment or make the subject unlikely to fully complete the study, or any condition that presents undue risk from the investigational product or procedures.
Significant illness, as judged by the Investigator, within 2 weeks of the first dose of investigational product.

Trial locations and contacts

1 site in 1 country.

France1 site

Biotrial
Rueil-Malmaison

Other trials in France

About this study

Official title: A Phase 1, Randomized, Double-blind, Placebo- and Positive-controlled, 4-Period Crossover Trial to Assess the Effect of Anagrelide Hydrochloride on QT/QTc Interval in Healthy Men and Women.

According to the ICH Guidance Document E14, all non-antiarrhythmic drugs should be evaluated for their ability to prolong the QT interval which represents the duration of ventricular depolarization and subsequent repolarization. The primary objective of the study is to assess the effect of anagrelide on QT/QTc interval following a therapeutic and supratherapeutic dose of anagrelide when compared to placebo and a positive control.

Conditions: Healthy
Being tested: Anagrelide 0.5 mg, Anagrelide 2.5 mg, Moxifloxacin, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Anagrelide 0.5 mgDrug
Also called Agrylin, Xagrid
0.5mg Anagrelide single oral dose
Anagrelide 2.5 mgDrug
2.5mg Anagrelide single oral dose
MoxifloxacinDrug
400 mg Moxifloxacin single oral dose
PlaceboDrug
Anagrelide placebo + Moxifloxacin placebo single oral dose

Study groups in NCT01552928
Study group	Role	What they receive
Anagrelide Therapeutic (0.5 mg)	Experimental	Not described Receives: Drug: Anagrelide 0.5 mg
Anagrelide Supratherapeutic (2.5 mg)	Experimental	Not described Receives: Drug: Anagrelide 2.5 mg
Moxifloxacin	Active comparator	Not described Receives: Drug: Moxifloxacin
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Difference Changes From Baseline Versus Placebo in QTcNi Intervals From Time-Matched Analysis by Largest Time Point
QT interval corrected for heart rate using the subject-specific method (QTcNi) at the subject-specific time of maximum plasma concentration. The QT interval is the time it takes for the ventricles of the heart to contract and relax. Data were subtracted from the placebo value. The largest time point refers to the estimated largest mean difference between each treatment and placebo among all time points. Values for different treatments can come from different time points.
Measured: Over 12 hours post-dose
Mean Difference Changes From Baseline Versus Placebo in Heart Rate From Time-Matched Analysis by Largest Time Point
The largest time point refers to the estimated largest mean difference between each treatment and placebo among all time points. Values for different treatments can come from different time points.
Measured: Over 12 hours post-dose
Mean Difference Changes From Baseline Versus Placebo in QTcF Intervals From Time-Matched Analysis by Largest Time Point
QT interval corrected for heart rate using Fridericia's method (QTcF) at the subject-specific time of maximum plasma concentration. The QT interval is the time it takes for the ventricles of the heart to contract and relax. Data were subtracted from the placebo value. The largest time point refers to the estimated largest mean difference between each treatment and placebo among all time points. Values for different treatments can come from different time points.
Measured: Over 12 hours post-dose
Mean Difference Changes From Baseline Versus Placebo in QTcB Intervals From Time-Matched Analysis by Largest Time Point
QT interval corrected for heart rate using Bazett's method (QTcB) at the subject-specific time of maximum plasma concentration. The QT interval is the time it takes for the ventricles of the heart to contract and relax. Data were subtracted from the placebo value. The largest time point refers to the estimated largest mean difference between each treatment and placebo among all time points. Values for different treatments can come from different time points.
Measured: Over 12 hours post-dose
Mean Difference Changes From Baseline Versus Placebo in QT Intervals From Time-Matched Analysis by Largest Time Point
The QT interval is the time it takes for the ventricles of the heart to contract and relax. Data were subtracted from the placebo value. The largest time point refers to the estimated largest mean difference between each treatment and placebo among all time points. Values for different treatments can come from different time points.
Measured: Over 12 hours post-dose

Secondary outcomes (9)

Mean Difference Changes From Baseline Versus Placebo in QTcNi Intervals at Subject-Specific Time of Maximum Plasma Concentration (Tmax)
QT interval corrected for heart rate using the subject-specific method (QTcNi) at the subject-specific time of maximum plasma concentration. The QT interval is the time it takes for the ventricles of the heart to contract and relax. Data were subtracted from the placebo value.
Measured: Over 12 hours post-dose
Mean Difference Changes From Baseline Versus Placebo in Heart Rate at Subject-Specific Tmax
Measured: Over 12 hours post-dose
Mean Difference Changes From Baseline Versus Placebo in QTcF Intervals at Subject-Specific Tmax
QT interval corrected for heart rate using Fridericia's method (QTcF) at the subject-specific time of maximum plasma concentration. The QT interval is the time it takes for the ventricles of the heart to contract and relax. Data were subtracted from the placebo value.
Measured: Over 12 hours post-dose
Mean Difference Changes From Baseline Versus Placebo in QTcB Intervals at Subject-Specific Tmax
QT interval corrected for heart rate using Bazett's method (QTcB) at the subject-specific time of maximum plasma concentration. The QT interval is the time it takes for the ventricles of the heart to contract and relax. Data were subtracted from the placebo value.
Measured: Over 12 hours post-dose
Mean Difference Changes From Baseline Versus Placebo in QT Intervals at Subject-Specific Tmax
The QT interval is the time it takes for the ventricles of the heart to contract and relax. Data were subtracted from the placebo value.
Measured: Over 12 hours post-dose
Maximum Plasma Concentration (Cmax) of 0.5 mg Anagrelide in Males and Females
Measured: Over 12 hours post-dose
Maximum Plasma Concentration (Cmax) of 2.5 mg Anagrelide in Males and Females
Measured: Over 12 hours post-dose
Maximum Plasma Concentration (Cmax) of Metabolite of 0.5 mg Anagrelide (BCH24426) in Males and Females
Measured: Over 12 hours post-dose
Maximum Plasma Concentration (Cmax) of Metabolite of 2.5 mg Anagrelide (BCH24426) in Males and Females
Measured: Over 12 hours post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Mar 201225 Jul 2012

First posted13 Mar 2012 (estimated)
Study start29 Mar 2012
Primary completion25 Jul 2012
Study completion25 Jul 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies 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: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01552928
Sponsor's protocol ID: SPD422-111
Other IDs: 2011-005288-26
Status last verified: May 2021
First submitted: 6 Mar 2012
Last updated: 9 Jun 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Randomized, Double-blind, Placebo- and Positive-controlled, 4-Period Crossover Trial to Assess the Effect of Anagrelide Hydrochloride on QT/QTc Interval in Healthy Men and Women.
ClinicalTrials.gov ID: NCT01552928
Acronym / sponsor ID: SPD422-111
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: ShireIndustry (pharma, biotech, devices)
Study start: 29 Mar 2012 (actual)
Primary completion: 25 Jul 2012 (actual)
Study completion: 25 Jul 2012 (actual)
First posted: 13 Mar 2012 (estimated)
Results: Posted 10 Jan 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Anagrelide Therapeutic (0.5 mg)	Experimental	Drug: Anagrelide 0.5 mg
Anagrelide Supratherapeutic (2.5 mg)	Experimental	Drug: Anagrelide 2.5 mg
Moxifloxacin	Active comparator	Drug: Moxifloxacin
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Age 18-45 years inclusive at the time of consent. The date of signing informed consent is defined as the beginning of the screening period. This inclusion criteria will only be assessed at the screening visit.
Subject is willing to comply with any applicable contraceptive requirements of the protocol and is: male, or non-pregnant non lactating female, or females must be at least 90 days post-partum or nulliparous.
Satisfactory medical assessment with no clinically or relevant abnormalities in medical history, physical examination, vital signs, ECG, and clinical laboratory evaluation as assessed by the investigator.

Key exclusion criteria (3 listed)

Current or recurrent disease that could affect the action, absorption, or disposition of the investigational product, or could affect clinical or laboratory assessments.
a- Current or relevant history of physical or psychiatric illness, any medical disorder that may require treatment or make the subject unlikely to fully complete the study, or any condition that presents undue risk from the investigational product or procedures.
Significant illness, as judged by the Investigator, within 2 weeks of the first dose of investigational product.

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
Anagrelide 0.5 mgAlso: Agrylin, Xagrid0.5mg Anagrelide single oral dose	Drug	Anagrelide Therapeutic (0.5 mg)
Anagrelide 2.5 mg2.5mg Anagrelide single oral dose	Drug	Anagrelide Supratherapeutic (2.5 mg)
Moxifloxacin400 mg Moxifloxacin single oral dose	Drug	Moxifloxacin
PlaceboAnagrelide placebo + Moxifloxacin placebo single oral dose	Drug	Placebo

Primary outcome

Mean Difference Changes From Baseline Versus Placebo in QTcNi Intervals From Time-Matched Analysis by Largest Time Point
Time frame: Over 12 hours post-dose
QT interval corrected for heart rate using the subject-specific method (QTcNi) at the subject-specific time of maximum plasma concentration. The QT interval is the time it takes for the ventricles of the heart to contract and relax. Data were subtracted from the placebo value. The largest time point refers to the estimated largest mean difference between each treatment and placebo among all time points. Values for different treatments can come from different time points.
Mean Difference Changes From Baseline Versus Placebo in Heart Rate From Time-Matched Analysis by Largest Time Point
Time frame: Over 12 hours post-dose
The largest time point refers to the estimated largest mean difference between each treatment and placebo among all time points. Values for different treatments can come from different time points.
Mean Difference Changes From Baseline Versus Placebo in QTcF Intervals From Time-Matched Analysis by Largest Time Point
Time frame: Over 12 hours post-dose
QT interval corrected for heart rate using Fridericia's method (QTcF) at the subject-specific time of maximum plasma concentration. The QT interval is the time it takes for the ventricles of the heart to contract and relax. Data were subtracted from the placebo value. The largest time point refers to the estimated largest mean difference between each treatment and placebo among all time points. Values for different treatments can come from different time points.
Mean Difference Changes From Baseline Versus Placebo in QTcB Intervals From Time-Matched Analysis by Largest Time Point
Time frame: Over 12 hours post-dose
QT interval corrected for heart rate using Bazett's method (QTcB) at the subject-specific time of maximum plasma concentration. The QT interval is the time it takes for the ventricles of the heart to contract and relax. Data were subtracted from the placebo value. The largest time point refers to the estimated largest mean difference between each treatment and placebo among all time points. Values for different treatments can come from different time points.
Mean Difference Changes From Baseline Versus Placebo in QT Intervals From Time-Matched Analysis by Largest Time Point
Time frame: Over 12 hours post-dose
The QT interval is the time it takes for the ventricles of the heart to contract and relax. Data were subtracted from the placebo value. The largest time point refers to the estimated largest mean difference between each treatment and placebo among all time points. Values for different treatments can come from different time points.

9 secondary outcomes

Mean Difference Changes From Baseline Versus Placebo in QTcNi Intervals at Subject-Specific Time of Maximum Plasma Concentration (Tmax)
Time frame: Over 12 hours post-dose
Mean Difference Changes From Baseline Versus Placebo in Heart Rate at Subject-Specific Tmax
Time frame: Over 12 hours post-dose
Mean Difference Changes From Baseline Versus Placebo in QTcF Intervals at Subject-Specific Tmax
Time frame: Over 12 hours post-dose
Mean Difference Changes From Baseline Versus Placebo in QTcB Intervals at Subject-Specific Tmax
Time frame: Over 12 hours post-dose
Mean Difference Changes From Baseline Versus Placebo in QT Intervals at Subject-Specific Tmax
Time frame: Over 12 hours post-dose
Maximum Plasma Concentration (Cmax) of 0.5 mg Anagrelide in Males and Females
Time frame: Over 12 hours post-dose
Maximum Plasma Concentration (Cmax) of 2.5 mg Anagrelide in Males and Females
Time frame: Over 12 hours post-dose
Maximum Plasma Concentration (Cmax) of Metabolite of 0.5 mg Anagrelide (BCH24426) in Males and Females
Time frame: Over 12 hours post-dose
Maximum Plasma Concentration (Cmax) of Metabolite of 2.5 mg Anagrelide (BCH24426) in Males and Females
Time frame: Over 12 hours post-dose

Results and safety

Results posted to the registry on 10 Jan 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Anag 0.5 mg, Then Anag 2.5 mg, Then Placebo, Then Mox 400 mg	14	14
Anag 2.5 mg, Then Mox 400 mg, Then Anag 0.5 mg, Then Placebo	15	15
Mox 400 mg, Then Placebo, Then Anag 2.5 mg, Then Anag 0.5 mg	15	15
Placebo, Then Anag 0.5 mg, Then Mox 400 mg, Then Anag 2.5 mg	16	16

Primary outcome: Mean Difference Changes From Baseline Versus Placebo in QTcNi Intervals From Time-Matched Analysis by Largest Time Point

Time frame: Over 12 hours post-dose. Least squares mean (90% Confidence Interval). Unit: msec

Measure	Anagrelide 0.5 mg n = 50	Anagrelide 2.5 mg n = 55	Moxifloxacin 400 mg n = 53
Value	7.0 (4.2 to 9.8)	13.0 (10.3 to 15.7)	12.6 (9.9 to 15.2)

Anagrelide 0.5 mg: p <0.001, ANCOVA
Anagrelide 2.5 mg: p <0.001, ANCOVA
Moxifloxacin 400 mg: p <0.001, ANCOVA

Population analysed: Full Analysis Set (FAS) consists of subjects in the Safety Analysis Set who had at least 1 electrocardiogram (ECG). Safety Analysis Set consists of subjects who received at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

Primary outcome: Mean Difference Changes From Baseline Versus Placebo in Heart Rate From Time-Matched Analysis by Largest Time Point

Time frame: Over 12 hours post-dose. Least squares mean (90% Confidence Interval). Unit: beats per minute

Measure	Anagrelide 0.5 mg n = 50	Anagrelide 2.5 mg n = 54	Moxifloxacin 400 mg n = 53
Value	7.8 (5.3 to 10.4)	29.1 (26.6 to 31.6)	4.3 (1.8 to 6.7)

Anagrelide 0.5 mg: p <0.001, ANCOVA
Anagrelide 2.5 mg: p <0.001, ANCOVA
Moxifloxacin 400 mg: p = 0.004, ANCOVA

Primary outcome: Mean Difference Changes From Baseline Versus Placebo in QTcF Intervals From Time-Matched Analysis by Largest Time Point

Time frame: Over 12 hours post-dose. Least squares mean (90% Confidence Interval). Unit: msec

Measure	Anagrelide 0.5 mg n = 50	Anagrelide 2.5 mg n = 55	Moxifloxacin 400 mg n = 53
Value	5.0 (2.1 to 8.0)	10.0 (7.3 to 12.7)	11.8 (8.9 to 14.8)

Anagrelide 0.5 mg: p = 0.005, ANCOVA
Anagrelide 2.5 mg: p <0.001, ANCOVA
Moxifloxacin 400 mg: p <0.001, ANCOVA

Primary outcome: Mean Difference Changes From Baseline Versus Placebo in QTcB Intervals From Time-Matched Analysis by Largest Time Point

Time frame: Over 12 hours post-dose. Least squares mean (90% Confidence Interval). Unit: msec

Measure	Anagrelide 0.5 mg n = 50	Anagrelide 2.5 mg n = 56	Moxifloxacin 400 mg n = 55
Value	-2.9 (-5.6 to -0.2)	-18.1 (-20.7 to -15.4)	-2.3 (-5.0 to 0.4)

Anagrelide 0.5 mg: p = 0.078, ANCOVA
Anagrelide 2.5 mg: p <0.001, ANCOVA
Moxifloxacin 400 mg: p = 0.156, ANCOVA

9 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Anagrelide 0.5mg	0 of 59 (0%)	13 of 59 (22%)	Not reported
Anagrelide 2.5mg	0 of 60 (0%)	49 of 60 (81.7%)	Not reported
Moxifloxacin 400mg	0 of 60 (0%)	2 of 60 (3.3%)	Not reported
Placebo	0 of 60 (0%)	0 of 60 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Study Director study director

Takeda

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 Anagrelide 0.5 mg, Anagrelide 2.5 mg and Moxifloxacin in people with Healthy, run by Shire at 1 site in France.

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 3 inclusion and 3 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 9 Jun 2021. 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 France. 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 10 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Mean Difference Changes From Baseline Versus Placebo in QTcNi Intervals From Time-Matched Analysis by Largest Time Point (time frame: Over 12 hours post-dose). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01552928.

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 9 Jun 2021.