NCT00672984

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
83

participants targeted

Target at P75+ for phase_1 healthy-volunteers

Timeline
Completed

Started Apr 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 18, 2008

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

May 2, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 6, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 7, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 7, 2008

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

December 21, 2009

Completed
Last Updated

June 14, 2021

Status Verified

June 1, 2021

Enrollment Period

4 months

First QC Date

May 2, 2008

Results QC Date

September 23, 2009

Last Update Submit

June 10, 2021

Conditions

Healthy Volunteers

Keywords

QT/QTc

Outcome Measures

Primary Outcomes (8)

  • Change From Baseline in Electrocardiogram Results (QTcNi) at Time of Maximum Plasma Concentration (Tmax) on Day 1

    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.

    Baseline, Tmax (time of subject-specific maximum plasma concentration)

  • Change From Baseline in Electrocardiogram Results (QTcNi) at Tmax on Day 6

    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.

    Baseline and Tmax (time of subject-specific maximum plasma concentration)

  • Change From Baseline in Electrocardiogram Results (QTcF) at Tmax on Day 1

    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.

    Baseline and Tmax (time of subject-specific maximum plasma concentration)

  • Change From Baseline in Electrocardiogram Results (QTcF) at Tmax on Day 6

    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.

    Baseline and Tmax (time of subject-specific maximum plasma concentration)

  • 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

    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).

    Baseline and Tmax (time of subject-specific maximum plasma concentration)

  • Change From Baseline in Electrocardiogram Results (QT) Interval at Tmax on Day 6

    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).

    Baseline and Tmax (time of subject-specific maximum plasma concentration)

Secondary Outcomes (6)

  • 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

  • Time of Maximum Plasma Concentration (Tmax) of Guanfacine and Moxifloxacin on Day 6

    pre-dose and 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose

  • Area Under the Steady-state Plasma Concentration-time Curve (AUC) for Guanfacine and Moxifloxacin on Day 1

    pre-dose and 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose

  • +1 more secondary outcomes

Study Arms (3)

Immediate-release Guanfacine HCl

EXPERIMENTAL
Drug: immediate release guanfacine hydrochloride

Moxifloxacin HCl

ACTIVE COMPARATOR
Drug: moxifloxacin

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

immediate release guanfacine hydrochlorideDRUG

Subjects will receive 2x2mg immediate-release guanfacine on day 1. Subjects will receive 4x2mg immediate-release guanfacine on day 6.

Also known as: Tenex
Immediate-release Guanfacine HCl
moxifloxacinDRUG

Subjects will receive 400mg of moxifloxacin on day 1. Subjects will receive 400mg of moxifloxacin on day 6.

Also known as: Avelox
Moxifloxacin HCl
PlaceboDRUG

Subjects will receive placebo on Day 1. Subjects will receive placebo on Day 6.

Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy Normal Subjects

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charles River Clinical Services Northwest, Inc.

Tacoma, Washington, United States

Location

Related Publications (1)

  • 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.

    PMID: 25109412DERIVED

Related Links

MeSH Terms

Interventions

GuanfacineMoxifloxacin

Intervention Hierarchy (Ancestors)

GuanidinesAmidinesOrganic ChemicalsPhenylacetatesAcids, CarbocyclicCarboxylic AcidsFluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title
Study Director
Organization
Shire
ClinicalTransparency@shire.com
+1 866 842 5335

Study Officials

  • Study Director

    Takeda

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2008

First Posted

May 6, 2008

Study Start

April 18, 2008

Primary Completion

August 7, 2008

Study Completion

August 7, 2008

Last Updated

June 14, 2021

Results First Posted

December 21, 2009

Record last verified: 2021-06

Locations

US(1)