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immediate release guanfacine

Phase 1

Undisclosed | Small molecule | Other |Takeda Pharmaceutical Company Limited|Trials Updated: Jun 14, 2021

immediate release guanfacine target and mechanism

ModalitySmall molecule

Also known as immediate release guanfacine hydrochloride, Tenex

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment83

FDA Designations

No designations recorded

immediate release guanfacine clinical trials

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?

Immediate release guanfacine is a small molecule drug developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. It is an immediate-release formulation of guanfacine hydrochloride. The drug has been studied in a Phase 1 clinical trial involving healthy volunteers, and its development is at the Phase 1 stage.

Who makes immediate release guanfacine?

Immediate release guanfacine is made by Takeda Pharmaceutical Company Limited, which is listed on the stock exchange under the ticker TAK. Takeda is the developer of this immediate-release formulation of guanfacine hydrochloride.

What phase is immediate release guanfacine in?

Immediate release guanfacine is in Phase 1 of clinical development. One Phase 1 trial has been completed, and there are currently no active trials. The drug is investigational and has not been approved by the FDA for any indication.

What clinical trials is immediate release guanfacine in?

Immediate release guanfacine has been studied in one completed Phase 1 clinical trial, NCT00672984, titled Guanfacine Immediate-release Electrocardiogram Results (QTc) Study. The trial enrolled 83 healthy volunteers in the United States, was randomized, double-blind, and placebo-controlled, and included participants aged 18 years and older of all sexes.

Is immediate release guanfacine the same as immediate release guanfacine hydrochloride?

Yes, immediate release guanfacine is also known as immediate release guanfacine hydrochloride. The hydrochloride salt form is the specific chemical name for the active ingredient in this immediate-release formulation developed by Takeda Pharmaceutical Company Limited.