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immediate release guanfacine

Phase 1

Healthy Volunteers | Small molecule | Other |Takeda Pharmaceutical Company Limited|Last Updated: Jun 14, 2021

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment83

FDA Designations

No designations recorded

Clinical trial landscape

immediate release guanfacine · 1 trial · 1 indication

Phase 1 1
NCT00672984Guanfacine Immediate-release Electrocardiogram Results (QTc) StudyHealthy Volunteers
COMPLETED83 Analytics
PHASE1COMPLETED
Guanfacine Immediate-release Electrocardiogram Results (QTc) Study
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Study Endpoints

Primary Endpoints

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

QTcNi is the QT interval using a subject-specific correction formula. QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate (e.g., the faster the heart rate, the shorter the QT interval). The QT interval has to be corrected in order to aid interpretation.

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

QTcNi is the QT interval using a subject-specific correction formula. QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate (e.g., the faster the heart rate, the shorter the QT interval). The QT interval has to be corrected in order to aid interpretation.

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

QTcF is the QT interval using Fridericia's correction formula. QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate (e.g., the faster the heart rate, the shorter the QT interval). The QT interval has to be corrected in order to aid interpretation.

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

QTcF is the QT interval using Fridericia's correction formula. QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate (e.g., the faster the heart rate, the shorter the QT interval). The QT interval has to be corrected in order to aid interpretation.

Change From Baseline in Heart Rate (HR) at Tmax on Day 1
Baseline and Tmax (time of subject-specific maximum plasma concentration)
Change From Baseline in Heart Rate (HR) at Tmax on Day 6
Baseline and Tmax (time of subject-specific maximum plasma concentration)
Change From Baseline in Electrocardiogram Results (QT) Interval at Tmax on Day 1
Baseline and Tmax (time of subject-specific maximum plasma concentration)

QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate (e.g., the faster the heart rate, the shorter the QT interval).

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

QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate (e.g., the faster the heart rate, the shorter the QT interval).

Secondary Endpoints

Maximum Plasma Concentration (Cmax) of Guanfacine and Moxifloxacin on Day 1
pre-dose and 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose
Maximum Plasma Concentration (Cmax) of Guanfacine and Moxifloxacin on Day 6
pre-dose and 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose
Time of Maximum Plasma Concentration (Tmax) of Guanfacine and Moxifloxacin on Day 1
pre-dose and 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Immediate-release Guanfacine HClEXPERIMENTAL -
Moxifloxacin HClACTIVE_COMPARATOR -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
immediate release guanfacine hydrochlorideDRUGSubjects will receive 2x2mg immediate-release guanfacine on day 1. Subjects will receive 4x2mg immediate-release guanfacine on day 6.
moxifloxacinDRUGSubjects will receive 400mg of moxifloxacin on day 1. Subjects will receive 400mg of moxifloxacin on day 6.
PlaceboDRUGSubjects will receive placebo on Day 1. Subjects will receive placebo on Day 6.
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Eligibility Criteria

Age Range18 Years to 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy Normal Subjects

Countries:United States
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Frequently asked questions about immediate release guanfacine

What is immediate release guanfacine used for?

Immediate release guanfacine is a small molecule being studied in healthy volunteers. It is currently in Phase 1 clinical development. The only completed trial evaluated its effects on the electrocardiogram, specifically the QTc interval, in healthy adult participants in the United States.

Who makes immediate release guanfacine?

Immediate release guanfacine is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The company conducted a Phase 1 study of the drug in healthy volunteers in the United States.

What phase is immediate release guanfacine in?

Immediate release guanfacine is in Phase 1 clinical development. It is an investigational drug and has not been approved. One Phase 1 trial, NCT00672984, has been completed, and no active trials are currently listed.

What clinical trials is immediate release guanfacine in?

Immediate release guanfacine has one completed clinical trial, NCT00672984, titled "Guanfacine Immediate-release Electrocardiogram Results (QTc) Study." This Phase 1, randomized, double-blind, placebo-controlled study enrolled 83 healthy volunteers in the United States.

Is immediate release guanfacine the same as guanfacine?

Immediate release guanfacine is a formulation of guanfacine, a small molecule. The clinical trial NCT00672984 specifically studied the immediate-release version of guanfacine to assess its effect on the QTc interval in healthy volunteers.