Clinical trial NCT00672984: Guanfacine Immediate-release Electrocardiogram Results (QTc) Study
Official title: A Phase I, Randomized, Gender Stratified, Double-Blind, Placebo- and Positive-Controlled, Three Period Crossover Trial to Assess the Effect of Guanfacine Hydrochloride on QT/QTc Interval in Healthy Men and Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: QT/QTc
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2008-05-06
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: To assess the effect of immediate-release guanfacine hydrochloride, administered at therapeutic and supratherapeutic doses, on QT/QTc in healthy normal males and females


Eligibility criteria: Inclusion Criteria:

* Healthy Normal Subjects

Primary outcomes:
measure: Change From Baseline in Electrocardiogram Results (QTcNi) at Time of Maximum Plasma Concentration (Tmax) on Day 1
timeFrame: Baseline, Tmax (time of subject-specific maximum plasma concentration)
measure: Change From Baseline in Electrocardiogram Results (QTcNi) at Tmax on Day 6
timeFrame: Baseline and Tmax (time of subject-specific maximum plasma concentration)
measure: Change From Baseline in Electrocardiogram Results (QTcF) at Tmax on Day 1
timeFrame: Baseline and Tmax (time of subject-specific maximum plasma concentration)
measure: Change From Baseline in Electrocardiogram Results (QTcF) at Tmax on Day 6
timeFrame: Baseline and Tmax (time of subject-specific maximum plasma concentration)
measure: Change From Baseline in Heart Rate (HR) at Tmax on Day 1
timeFrame: Baseline and Tmax (time of subject-specific maximum plasma concentration)
measure: Change From Baseline in Heart Rate (HR) at Tmax on Day 6
timeFrame: Baseline and Tmax (time of subject-specific maximum plasma concentration)
measure: Change From Baseline in Electrocardiogram Results (QT) Interval at Tmax on Day 1
timeFrame: Baseline and Tmax (time of subject-specific maximum plasma concentration)
measure: Change From Baseline in Electrocardiogram Results (QT) Interval at Tmax on Day 6
timeFrame: Baseline and Tmax (time of subject-specific maximum plasma concentration)
Secondary outcomes:
measure: Maximum Plasma Concentration (Cmax) of Guanfacine and Moxifloxacin on Day 1
timeFrame: pre-dose and 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose
measure: Maximum Plasma Concentration (Cmax) of Guanfacine and Moxifloxacin on Day 6
timeFrame: pre-dose and 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose
measure: Time of Maximum Plasma Concentration (Tmax) of Guanfacine and Moxifloxacin on Day 1
timeFrame: pre-dose and 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose
measure: Time of Maximum Plasma Concentration (Tmax) of Guanfacine and Moxifloxacin on Day 6
timeFrame: pre-dose and 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose
measure: Area Under the Steady-state Plasma Concentration-time Curve (AUC) for Guanfacine and Moxifloxacin on Day 1
timeFrame: pre-dose and 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose
measure: Area Under the Steady-state Plasma Concentration-time Curve (AUC) for Guanfacine and Moxifloxacin on Day 6
timeFrame: pre-dose and 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose
Other outcomes:
Locations:
city: Tacoma
country: United States
facility: Charles River Clinical Services Northwest, Inc.
state: Washington
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
citation: Martin P, Satin L, Kahn RS, Robinson A, Corcoran M, Purkayastha J, Youcha S, Ermer JC. A thorough QT study of guanfacine. Int J Clin Pharmacol Ther. 2015 Apr;53(4):301-16. doi: 10.5414/CP202065.