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

Shire

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: Anagrelide 0.5 mg; Drug: Anagrelide 2.5 mg; Drug: Moxifloxacin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01552928

SPD422-111

2011-005288-26 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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60 participants in 4 patient groups, including a placebo group

Anagrelide Therapeutic (0.5 mg)

Experimental group

Treatment:

Drug: Anagrelide 0.5 mg

Anagrelide Supratherapeutic (2.5 mg)

Experimental group

Treatment:

Drug: Anagrelide 2.5 mg

Moxifloxacin

Active Comparator group

Treatment:

Drug: Moxifloxacin

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo