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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01552928
• Date of registration: 06/03/2012
• Prospective Registration: No
• Primary sponsor: Shire
• Public title: Effect of Anagrelide Hydrochloride on Any Changes in Heart Function in Healthy Volunteers
• Scientific 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.
• Date of first enrolment: March 2012
• Target sample size: 60
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01552928
• Study type: Interventional
• Phase: Phase 1

Countries of recruitment

France

Contacts

• Name: Nicolas Fauchoux
• Affiliation: Biotrial

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.



Age minimum: 18 Years
Age maximum: 45 Years
Gender: All

Health Condition(s) or Problem(s) studied

Healthy

Intervention(s)

Drug: Anagrelide 0.5 mg

Drug: Moxifloxacin

Drug: Placebo

Drug: Anagrelide 2.5 mg

Primary Outcome(s)

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]

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]

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]

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]

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]

Secondary Outcome(s)

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]

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]

Maximum Plasma Concentration (Cmax) of 0.5 mg Anagrelide in Males and Females [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]

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 QTcNi Intervals at Subject-Specific Time of Maximum Plasma Concentration (Tmax) [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]

Secondary ID(s)

SPD422-111

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 10/01/2014
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01552928