Phase 1
N=60
Effect of Anagrelide Hydrochloride on Any Changes in Heart Function in Healthy Volunteers
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT01552928 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Jan 2014
Primary outcome: Primary: Mean Difference Changes From Baseline Versus Placebo in QTcNi Intervals From Time-Matched Analysis by Largest Time Point — 7.0; 13.0; 12.6 msec — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Anagrelide 0.5 mg (Drug); Anagrelide 2.5 mg (Drug); Moxifloxacin (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Shire
- Primary completion
- Jul 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Difference Changes From Baseline Versus Placebo in QTcNi Intervals From Time-Matched Analysis by Largest Time Point |
7.0; 13.0; 12.6 | <0.001 sig |
| PRIMARY Mean Difference Changes From Baseline Versus Placebo in Heart Rate From Time-Matched Analysis by Largest Time Point |
7.8; 29.1; 4.3 | <0.001 sig |
| PRIMARY Mean Difference Changes From Baseline Versus Placebo in QTcF Intervals From Time-Matched Analysis by Largest Time Point |
5.0; 10.0; 11.8 | 0.005 sig |
| PRIMARY Mean Difference Changes From Baseline Versus Placebo in QTcB Intervals From Time-Matched Analysis by Largest Time Point |
-2.9; -18.1; -2.3 | 0.078 |
| PRIMARY Mean Difference Changes From Baseline Versus Placebo in QT Intervals From Time-Matched Analysis by Largest Time Point |
1.7; -2.4; 9.6 | 0.439 |
| SECONDARY Mean Difference Changes From Baseline Versus Placebo in QTcNi Intervals at Subject-Specific Time of Maximum Plasma Concentration (Tmax) |
4.4; 8.2; 11.3 | 0.004 sig |
| SECONDARY Mean Difference Changes From Baseline Versus Placebo in Heart Rate at Subject-Specific Tmax |
4.5; 21.8; 2.9 | <0.001 sig |
| SECONDARY Mean Difference Changes From Baseline Versus Placebo in QTcF Intervals at Subject-Specific Tmax |
3.7; 4.5; 10.8 | 0.012 sig |
| SECONDARY Mean Difference Changes From Baseline Versus Placebo in QTcB Intervals at Subject-Specific Tmax |
8.5; 25.5; 14.0 | <0.001 sig |
| SECONDARY Mean Difference Changes From Baseline Versus Placebo in QT Intervals at Subject-Specific Tmax |
-6.1; -34.3; 4.3 | 0.003 sig |
| SECONDARY Maximum Plasma Concentration (Cmax) of 0.5 mg Anagrelide in Males and Females |
2.083; 3.64 | — |
| SECONDARY Maximum Plasma Concentration (Cmax) of 2.5 mg Anagrelide in Males and Females |
10.592; 16.378 | — |
| SECONDARY Maximum Plasma Concentration (Cmax) of Metabolite of 0.5 mg Anagrelide (BCH24426) in Males and Females |
3.731; 4.534 | — |
| SECONDARY Maximum Plasma Concentration (Cmax) of Metabolite of 2.5 mg Anagrelide (BCH24426) in Males and Females |
18.927; 23.785 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01552928). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.