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

NCT01552928 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2021-06-09

Study results available
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Summary

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

Interventions

DRUG

Anagrelide 0.5 mg

0.5mg Anagrelide single oral dose

DRUG

Anagrelide 2.5 mg

2.5mg Anagrelide single oral dose

DRUG

Moxifloxacin

400 mg Moxifloxacin single oral dose

DRUG

Placebo

Anagrelide placebo + Moxifloxacin placebo single oral dose

Sponsors & Collaborators

  • Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-03-29
Primary Completion
2012-07-25
Completion
2012-07-25

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01552928 on ClinicalTrials.gov