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

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Anag 0.5 mg, Then Anag 2.5 mg, Then Placebo, Then Mox 400 mg	A single oral dose of 0.5 mg of anagrelide on Day 1 for Period 1; then a single oral dose of 2.5 mg of anagrelide on Day 1 for Period 2; then a single oral dose of placebo on Day 1 for Period 3; then a single oral dose of 400 mg of moxifloxacin on Day 1 for Period 4.
Anag 2.5 mg, Then Mox 400 mg, Then Anag 0.5 mg, Then Placebo	A single oral dose of 2.5 mg of anagrelide on Day 1 for Period 1; then a single oral dose of 400 mg of moxifloxacin on Day 1 for Period 2; then a single oral dose of 0.5 mg of anagrelide on Day 1 for Period 3; then a single oral dose of placebo on Day 1 for Period 4.
Mox 400 mg, Then Placebo, Then Anag 2.5 mg, Then Anag 0.5 mg	A single oral dose of 400 mg of moxifloxacin on Day 1 for Period 1; then a single oral dose of placebo on Day 1 for Period 2; then a single oral dose of 2.5 mg of anagrelide on Day 1 for Period 3; then a single oral dose of 0.5 mg of anagrelide on Day 1 for Period 4.
Placebo, Then Anag 0.5 mg, Then Mox 400 mg, Then Anag 2.5 mg	A single oral dose of placebo on Day 1 for Period 1; then a single oral dose of 0.5 mg of anagrelide on Day 1 for Period 2; then a single oral dose of 400 mg of moxifloxacin on Day 1 for Period 3; then a single oral dose of 2.5 mg of anagrelide on Day 1 for Period 4.

Participant Flow for 4 periods

Period 1:   Period 1

	Anag 0.5 mg, Then Anag 2.5 mg, Then Placebo, Then Mox 400 mg	Anag 2.5 mg, Then Mox 400 mg, Then Anag 0.5 mg, Then Placebo	Mox 400 mg, Then Placebo, Then Anag 2.5 mg, Then Anag 0.5 mg	Placebo, Then Anag 0.5 mg, Then Mox 400 mg, Then Anag 2.5 mg
STARTED	14	15	15	16
COMPLETED	14	15	15	16
NOT COMPLETED	0	0	0	0

Period 2:   Period 2

	Anag 0.5 mg, Then Anag 2.5 mg, Then Placebo, Then Mox 400 mg	Anag 2.5 mg, Then Mox 400 mg, Then Anag 0.5 mg, Then Placebo	Mox 400 mg, Then Placebo, Then Anag 2.5 mg, Then Anag 0.5 mg	Placebo, Then Anag 0.5 mg, Then Mox 400 mg, Then Anag 2.5 mg
STARTED	14	15	15	16
COMPLETED	14	15	15	16
NOT COMPLETED	0	0	0	0

Period 3:   Period 3

	Anag 0.5 mg, Then Anag 2.5 mg, Then Placebo, Then Mox 400 mg	Anag 2.5 mg, Then Mox 400 mg, Then Anag 0.5 mg, Then Placebo	Mox 400 mg, Then Placebo, Then Anag 2.5 mg, Then Anag 0.5 mg	Placebo, Then Anag 0.5 mg, Then Mox 400 mg, Then Anag 2.5 mg
STARTED	14	15	15	16
COMPLETED	14	15	14	16
NOT COMPLETED	0	0	1	0
Adverse Event	0	0	1	0

Period 4:   Period 4

	Anag 0.5 mg, Then Anag 2.5 mg, Then Placebo, Then Mox 400 mg	Anag 2.5 mg, Then Mox 400 mg, Then Anag 0.5 mg, Then Placebo	Mox 400 mg, Then Placebo, Then Anag 2.5 mg, Then Anag 0.5 mg	Placebo, Then Anag 0.5 mg, Then Mox 400 mg, Then Anag 2.5 mg
STARTED	14	15	14	16
COMPLETED	14	15	14	16
NOT COMPLETED	0	0	0	0

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
Anag 0.5 mg, Then Anag 2.5 mg, Then Placebo, Then Mox 400 mg	A single oral dose of 0.5 mg of anagrelide on Day 1 for Period 1; then a single oral dose of 2.5 mg of anagrelide on Day 1 for Period 2; then a single oral dose of placebo on Day 1 for Period 3; then a single oral dose of 400 mg of moxifloxacin on Day 1 for Period 4.
Anag 2.5 mg, Then Mox 400 mg, Then Anag 0.5 mg, Then Placebo	A single oral dose of 2.5 mg of anagrelide on Day 1 for Period 1; then a single oral dose of 400 mg of moxifloxacin on Day 1 for Period 2; then a single oral dose of 0.5 mg of anagrelide on Day 1 for Period 3; then a single oral dose of placebo on Day 1 for Period 4.
Mox 400 mg, Then Placebo, Then Anag 2.5 mg, Then Anag 0.5 mg	A single oral dose of 400 mg of moxifloxacin on Day 1 for Period 1; then a single oral dose of placebo on Day 1 for Period 2; then a single oral dose of 2.5 mg of anagrelide on Day 1 for Period 3; then a single oral dose of 0.5 mg of anagrelide on Day 1 for Period 4.
Placebo, Then Anag 0.5 mg, Then Mox 400 mg, Then Anag 2.5 mg	A single oral dose of placebo on Day 1 for Period 1; then a single oral dose of 0.5 mg of anagrelide on Day 1 for Period 2; then a single oral dose of 400 mg of moxifloxacin on Day 1 for Period 3; then a single oral dose of 2.5 mg of anagrelide on Day 1 for Period 4.
Total	Total of all reporting groups

Baseline Measures

	Anag 0.5 mg, Then Anag 2.5 mg, Then Placebo, Then Mox 400 mg	Anag 2.5 mg, Then Mox 400 mg, Then Anag 0.5 mg, Then Placebo	Mox 400 mg, Then Placebo, Then Anag 2.5 mg, Then Anag 0.5 mg	Placebo, Then Anag 0.5 mg, Then Mox 400 mg, Then Anag 2.5 mg	Total
Overall Participants Analyzed  [Units: Participants]	14	15	15	16	60
Age  [Units: Participants]
<=18 years	0	0	0	0	0
Between 18 and 65 years	14	15	15	16	60
>=65 years	0	0	0	0	0
Age  [Units: Years] Mean (Standard Deviation)	28.1  (6.44)	28.4  (7.7)	29.5  (5.83)	30.4  (8.02)	29.2  (6.96)
Gender  [Units: Participants]
Female	6	6	6	7	25
Male	8	9	9	9	35
Region of Enrollment  [Units: Participants]
FRANCE	14	15	15	16	60

1.  Primary:

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 ]

2.  Primary:

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 ]

3.  Primary:

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 ]

4.  Primary:

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 ]

5.  Primary:

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 ]

6.  Secondary:

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 ]

7.  Secondary:

Mean Difference Changes From Baseline Versus Placebo in Heart Rate at Subject-Specific Tmax   [ Time Frame: Over 12 hours post-dose ]

8.  Secondary:

Mean Difference Changes From Baseline Versus Placebo in QTcF Intervals at Subject-Specific Tmax   [ Time Frame: Over 12 hours post-dose ]

9.  Secondary:

Mean Difference Changes From Baseline Versus Placebo in QTcB Intervals at Subject-Specific Tmax   [ Time Frame: Over 12 hours post-dose ]

10.  Secondary:

Mean Difference Changes From Baseline Versus Placebo in QT Intervals at Subject-Specific Tmax   [ Time Frame: Over 12 hours post-dose ]

11.  Secondary:

Maximum Plasma Concentration (Cmax) of 0.5 mg Anagrelide in Males and Females   [ Time Frame: Over 12 hours post-dose ]

12.  Secondary:

Maximum Plasma Concentration (Cmax) of 2.5 mg Anagrelide in Males and Females   [ Time Frame: Over 12 hours post-dose ]

13.  Secondary:

Maximum Plasma Concentration (Cmax) of Metabolite of 0.5 mg Anagrelide (BCH24426) in Males and Females   [ Time Frame: Over 12 hours post-dose ]

14.  Secondary:

Maximum Plasma Concentration (Cmax) of Metabolite of 2.5 mg Anagrelide (BCH24426) in Males and Females   [ Time Frame: Over 12 hours post-dose ]

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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