immediate release guanfacine - Healthy Volunteers | Phase 1 | Takeda Pharmaceutical Company Limited | BiopharmaWatch

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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

Approval Probability 71%

TA Base Rate26%

Adjusted LOA41%

ML RiskLOW_RISK

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Market & Valuation

rNPV $3.2B

Market Size $9.4B

Revenue Basis $1.6B

Competitors 6

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED

Total Trials1

Total Enrollment83

FDA Designations

No designations recorded

Clinical Trials (1)

NCT ID	Title	Phase	Status	Enrollment	Velocity	Design	Start	Completion	Last Updated	Sites	Countries
NCT00672984	Guanfacine Immediate-release Electrocardiogram Results (QTc) Study	PHASE1	COMPLETED	83	—	—	Apr 18, 2008	Aug 7, 2008	Jun 14, 2021	1	United States

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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

Arm	Type	Description
Immediate-release Guanfacine HCl	EXPERIMENTAL	-
Moxifloxacin HCl	ACTIVE_COMPARATOR	-
Placebo	PLACEBO_COMPARATOR	-

Interventions

Name	Type	Description
immediate release guanfacine hydrochloride	DRUG	Subjects will receive 2x2mg immediate-release guanfacine on day 1. Subjects will receive 4x2mg immediate-release guanfacine on day 6.
moxifloxacin	DRUG	Subjects will receive 400mg of moxifloxacin on day 1. Subjects will receive 400mg of moxifloxacin on day 6.
Placebo	DRUG	Subjects will receive placebo on Day 1. Subjects will receive placebo on Day 6.

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Eligibility Criteria

Age Range18 Years — 45 Years

SexALL

Healthy VolunteersYes

Study Sites1

Inclusion Criteria: * Healthy Normal Subjects

Countries:United States

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