Guanfacine Immediate-release Electrocardiogram Results (QTc) Study

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
This is a three period crossover trial.

Reporting Groups

	Description
Guanfacine First	Single 4 mg dose of immediate-release Guanfacine HCl on Day 1, 4 mg of immediate-release Guanfacine HCl bid on Days 2 and 3, 6 mg of immediate-release Guanfacine HCl bid on Days 4 and 5, and a single 8 mg dose of immediate-release Guanfacine HCl on Day 6 in first intervention period; single 400 mg dose of Moxifloxacin on Day 1, placebo bid on Days 2, 3, 4, and 5, and single 400 mg dose of Moxifloxacin on Day 6 in second intervention period (after washout period); single dose of placebo on Day 1, placebo bid on Days 2, 3, 4, and 5, and single dose of placebo on Day 6 in third intervention period (after washout period).
Moxifloxacin First	Single 400 mg dose of Moxifloxacin on Day 1, placebo bid on Days 2, 3, 4, and 5, and single 400 mg dose of Moxifloxacin on Day 6 in first intervention period; single dose of placebo on Day 1, placebo bid on Days 2, 3, 4, and 5, and single dose of placebo on Day 6 in second intervention period (after washout period); single 4 mg dose of immediate-release Guanfacine HCl on Day 1, 4 mg of immediate-release Guanfacine HCl bid on Days 2 and 3, 6 mg of immediate-release Guanfacine HCl bid on Days 4 and 5, and a single 8 mg dose of immediate-release Guanfacine HCl on Day 6 in third intervention period (after washout period).
Placebo First	Single dose of placebo on Day 1, placebo bid on Days 2, 3, 4, and 5, and single dose of placebo on Day 6 in first intervention period; single 4 mg dose of immediate-release Guanfacine HCl on Day 1, 4 mg of immediate-release Guanfacine HCl bid on Days 2 and 3, 6 mg of immediate-release Guanfacine HCl bid on Days 4 and 5, and a single 8 mg dose of immediate-release Guanfacine HCl on Day 6 in second intervention period (after washout period); single 400 mg dose of Moxifloxacin on Day 1, placebo bid on Days 2, 3, 4, and 5, and single 400 mg dose of Moxifloxacin on Day 6 in third intervention period (after washout period).

Participant Flow for 3 periods

Period 1:   First Intervention

	Guanfacine First	Moxifloxacin First	Placebo First
STARTED	31	25	27
COMPLETED	22	23	25
NOT COMPLETED	9	2	2
Adverse Event	5	0	0
Withdrawal by Subject	1	2	2
Sponsor decision	3	0	0

Period 2:   Second Intervention

	Guanfacine First	Moxifloxacin First	Placebo First
STARTED	22	23	25
COMPLETED	22	17	24
NOT COMPLETED	0	6	1
Non-compliance with facility policies	0	2	0
Withdrawal by Subject	0	3	0
Protocol Violation	0	1	1

Period 3:   Third Intervention

	Guanfacine First	Moxifloxacin First	Placebo First
STARTED	22	17	24
COMPLETED	21	17	23
NOT COMPLETED	1	0	1
Adverse Event	1	0	1

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.
No text entered.

Reporting Groups

	Description
Guanfacine First	Single 4 mg dose of immediate-release Guanfacine HCl on Day 1, 4 mg of immediate-release Guanfacine HCl bid on Days 2 and 3, 6 mg of immediate-release Guanfacine HCl bid on Days 4 and 5, and a single 8 mg dose of immediate-release Guanfacine HCl on Day 6 in first intervention period; single 400 mg dose of Moxifloxacin on Day 1, placebo bid on Days 2, 3, 4, and 5, and single 400 mg dose of Moxifloxacin on Day 6 in second intervention period (after washout period); single dose of placebo on Day 1, placebo bid on Days 2, 3, 4, and 5, and single dose of placebo on Day 6 in third intervention period (after washout period).
Moxifloxacin First	Single 400 mg dose of Moxifloxacin on Day 1, placebo bid on Days 2, 3, 4, and 5, and single 400 mg dose of Moxifloxacin on Day 6 in first intervention period; single dose of placebo on Day 1, placebo bid on Days 2, 3, 4, and 5, and single dose of placebo on Day 6 in second intervention period (after washout period); single 4 mg dose of immediate-release Guanfacine HCl on Day 1, 4 mg of immediate-release Guanfacine HCl bid on Days 2 and 3, 6 mg of immediate-release Guanfacine HCl bid on Days 4 and 5, and a single 8 mg dose of immediate-release Guanfacine HCl on Day 6 in third intervention period (after washout period).
Placebo First	Single dose of placebo on Day 1, placebo bid on Days 2, 3, 4, and 5, and single dose of placebo on Day 6 in first intervention period; single 4 mg dose of immediate-release Guanfacine HCl on Day 1, 4 mg of immediate-release Guanfacine HCl bid on Days 2 and 3, 6 mg of immediate-release Guanfacine HCl bid on Days 4 and 5, and a single 8 mg dose of immediate-release Guanfacine HCl on Day 6 in second intervention period (after washout period); single 400 mg dose of Moxifloxacin on Day 1, placebo bid on Days 2, 3, 4, and 5, and single 400 mg dose of Moxifloxacin on Day 6 in third intervention period (after washout period).
Total	Total of all reporting groups

Baseline Measures

	Guanfacine First	Moxifloxacin First	Placebo First	Total
Overall Participants Analyzed  [Units: Participants]	31	25	27	83
Age  [Units: Participants] Count of Participants
<=18 years	0   0.0%	0   0.0%	0   0.0%	0   0.0%
Between 18 and 65 years	31 100.0%	25 100.0%	27 100.0%	83 100.0%
>=65 years	0   0.0%	0   0.0%	0   0.0%	0   0.0%
Age  [Units: Years] Mean (Standard Deviation)	27.7  (7.55)	30.8  (10.02)	30.2  (8.71)	29.4  (8.61)
Sex: Female, Male  [Units: Participants] Count of Participants
Female	16  51.6%	13  52.0%	14  51.9%	43  51.8%
Male	15  48.4%	12  48.0%	13  48.1%	40  48.2%
Region of Enrollment  [Units: Participants]
United States	31	25	27	83

1.  Primary:

Change From Baseline in Electrocardiogram Results (QTcNi) at Time of Maximum Plasma Concentration (Tmax) on Day 1   [ Time Frame: Baseline, Tmax (time of subject-specific maximum plasma concentration) ]

2.  Primary:

Change From Baseline in Electrocardiogram Results (QTcNi) at Tmax on Day 6   [ Time Frame: Baseline and Tmax (time of subject-specific maximum plasma concentration) ]

3.  Primary:

Change From Baseline in Electrocardiogram Results (QTcF) at Tmax on Day 1   [ Time Frame: Baseline and Tmax (time of subject-specific maximum plasma concentration) ]

4.  Primary:

Change From Baseline in Electrocardiogram Results (QTcF) at Tmax on Day 6   [ Time Frame: Baseline and Tmax (time of subject-specific maximum plasma concentration) ]

5.  Primary:

Change From Baseline in Heart Rate (HR) at Tmax on Day 1   [ Time Frame: Baseline and Tmax (time of subject-specific maximum plasma concentration) ]

6.  Primary:

Change From Baseline in Heart Rate (HR) at Tmax on Day 6   [ Time Frame: Baseline and Tmax (time of subject-specific maximum plasma concentration) ]

7.  Primary:

Change From Baseline in Electrocardiogram Results (QT) Interval at Tmax on Day 1   [ Time Frame: Baseline and Tmax (time of subject-specific maximum plasma concentration) ]

8.  Primary:

Change From Baseline in Electrocardiogram Results (QT) Interval at Tmax on Day 6   [ Time Frame: Baseline and Tmax (time of subject-specific maximum plasma concentration) ]

9.  Secondary:

Maximum Plasma Concentration (Cmax) of Guanfacine and Moxifloxacin on Day 1   [ Time Frame: pre-dose and 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose ]

10.  Secondary:

Maximum Plasma Concentration (Cmax) of Guanfacine and Moxifloxacin on Day 6   [ Time Frame: pre-dose and 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose ]

11.  Secondary:

Time of Maximum Plasma Concentration (Tmax) of Guanfacine and Moxifloxacin on Day 1   [ Time Frame: pre-dose and 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose ]

12.  Secondary:

Time of Maximum Plasma Concentration (Tmax) of Guanfacine and Moxifloxacin on Day 6   [ Time Frame: pre-dose and 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose ]

13.  Secondary:

Area Under the Steady-state Plasma Concentration-time Curve (AUC) for Guanfacine and Moxifloxacin on Day 1   [ Time Frame: pre-dose and 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose ]

14.  Secondary:

Area Under the Steady-state Plasma Concentration-time Curve (AUC) for Guanfacine and Moxifloxacin on Day 6   [ Time Frame: pre-dose and 1, 2, 3, 4, 5, 6, 8, 12, and 24 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
No text entered.