Healthy VolunteersPhase 1NCT00672984

Guanfacine Immediate-release Electrocardiogram Results (QTc) Study

A Phase 1 study testing immediate release guanfacine hydrochloride and moxifloxacin in people with Healthy Volunteers, run by Shire at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: immediate release guanfacine hydrochloride and moxifloxacin
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 83 participants
Where: 1 siteUnited States
Study dates: 18 Apr 2008to 7 Aug 2008
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy Normal Subjects

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

Charles River Clinical Services Northwest, Inc.
Tacoma, Washington

Other trials in United States

About this 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

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

Conditions: Healthy Volunteers
Being tested: immediate release guanfacine hydrochloride, moxifloxacin, Placebo
Keywords: QT/QTc

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

immediate release guanfacine hydrochlorideDrug
Also called Tenex
Subjects will receive 2x2mg immediate-release guanfacine on day 1. Subjects will receive 4x2mg immediate-release guanfacine on day 6.
moxifloxacinDrug
Also called Avelox
Subjects will receive 400mg of moxifloxacin on day 1. Subjects will receive 400mg of moxifloxacin on day 6.
PlaceboDrug
Subjects will receive placebo on Day 1. Subjects will receive placebo on Day 6.

Study groups in NCT00672984
Study group	Role	What they receive
Immediate-release Guanfacine HCl	Experimental	Not described Receives: Drug: immediate release guanfacine hydrochloride
Moxifloxacin HCl	Active comparator	Not described Receives: Drug: moxifloxacin
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and Tmax (time of subject-specific maximum plasma concentration)
Change From Baseline in Heart Rate (HR) at Tmax on Day 1
Measured: Baseline and Tmax (time of subject-specific maximum plasma concentration)
Change From Baseline in Heart Rate (HR) at Tmax on Day 6
Measured: 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).
Measured: 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).
Measured: Baseline and Tmax (time of subject-specific maximum plasma concentration)

Secondary outcomes (6)

Maximum Plasma Concentration (Cmax) of Guanfacine and Moxifloxacin on Day 1
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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 6
Measured: pre-dose and 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Apr 20087 Aug 2008

First posted6 May 2008 (estimated)
Study start18 Apr 2008
Primary completion7 Aug 2008
Study completion7 Aug 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Healthy VolunteersStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 83 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00672984
Sponsor's protocol ID: SPD503-112
Status last verified: Jun 2021
First submitted: 2 May 2008
Last updated: 14 Jun 2021
Results posted: Yes, on ClinicalTrials.gov

Publications

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.
PubMed 25109412

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Healthy Volunteers trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00672984
Acronym / sponsor ID: SPD503-112
Conditions: Healthy Volunteers
Keywords: QT/QTc
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 83 participants (actual)
Lead sponsor: ShireIndustry (pharma, biotech, devices)
Study start: 18 Apr 2008 (actual)
Primary completion: 7 Aug 2008 (actual)
Study completion: 7 Aug 2008 (actual)
First posted: 6 May 2008 (estimated)
Results: Posted 21 Dec 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Immediate-release Guanfacine HCl	Experimental	Drug: immediate release guanfacine hydrochloride
Moxifloxacin HCl	Active comparator	Drug: moxifloxacin
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

Healthy Normal Subjects

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
immediate release guanfacine hydrochlorideAlso: TenexSubjects will receive 2x2mg immediate-release guanfacine on day 1. Subjects will receive 4x2mg immediate-release guanfacine on day 6.	Drug	Immediate-release Guanfacine HCl
moxifloxacinAlso: AveloxSubjects will receive 400mg of moxifloxacin on day 1. Subjects will receive 400mg of moxifloxacin on day 6.	Drug	Moxifloxacin HCl
PlaceboSubjects will receive placebo on Day 1. Subjects will receive placebo on Day 6.	Drug	Placebo

Primary outcome

Change From Baseline in Electrocardiogram Results (QTcNi) at Time of Maximum Plasma Concentration (Tmax) on Day 1
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline and Tmax (time of subject-specific maximum plasma concentration)
Change From Baseline in Heart Rate (HR) at Tmax on Day 6
Time frame: Baseline and Tmax (time of subject-specific maximum plasma concentration)
Change From Baseline in Electrocardiogram Results (QT) Interval at Tmax on Day 1
Time frame: 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
Time frame: 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).

6 secondary outcomes

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

Results and safety

Results posted to the registry on 21 Dec 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Guanfacine First	31	22
Moxifloxacin First	25	23
Placebo First	27	25

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

Time frame: Baseline, Tmax (time of subject-specific maximum plasma concentration). Least squares mean (Standard Error). Unit: msec

Measure	Guanfacine 4 mg n = 57	Moxifloxacin n = 58	Placebo (Guanfacine) n = 57	Placebo (Moxifloxacin) n = 58
Value	-3.37 (1.00)	12.96 (1.03)	-0.94 (1.02)	-0.91 (1.04)

Guanfacine 4 mg vs Placebo (Guanfacine): Mean Difference (Final Values): -2.43 (90% CI -4.52 to -0.34)
Moxifloxacin vs Placebo (Moxifloxacin): Mean Difference (Final Values): 13.87 (90% CI 11.45 to 16.29)

Population analysed: Pharmacodynamic (PD) population consists of all evaluable subjects with no major protocol deviations. "Evaluable" subjects were defined as subjects who received a Day 6 dose and had Day 6 data for the primary and secondary endpoints for all three periods.

Primary outcome: Change From Baseline in Electrocardiogram Results (QTcNi) at Tmax on Day 6

Time frame: Baseline and Tmax (time of subject-specific maximum plasma concentration). Least squares mean (Standard Error). Unit: msec

Measure	Guanfacine 8 mg n = 58	Moxifloxacin n = 45	Placebo (Guanfacine) n = 58	Placebo (Moxifloxacin) n = 44
Value	-12.45 (1.50)	8.99 (1.79)	-4.37 (1.52)	-4.13 (1.84)

Guanfacine 8 mg vs Placebo (Guanfacine): Mean Difference (Final Values): -8.08 (90% CI -11.37 to -4.78)
Moxifloxacin vs Placebo (Moxifloxacin): Mean Difference (Final Values): 13.13 (90% CI 9.33 to 16.93)

Population analysed: PD population

Primary outcome: Change From Baseline in Electrocardiogram Results (QTcF) at Tmax on Day 1

Time frame: Baseline and Tmax (time of subject-specific maximum plasma concentration). Least squares mean (Standard Error). Unit: msec

Measure	Guanfacine 4 mg n = 57	Moxifloxacin n = 58	Placebo (Guanfacine) n = 57	Placebo (Moxifloxacin) n = 58
Value	0.15 (0.96)	9.96 (0.92)	-0.83 (0.97)	-1.14 (0.92)

Guanfacine 4 mg vs Placebo (Guanfacine): Mean Difference (Final Values): 0.98 (90% CI -1.07 to 3.03)
Moxifloxacin vs Placebo (Moxifloxacin): Mean Difference (Final Values): 11.11 (90% CI 8.97 to 13.24)

Population analysed: PD population

Primary outcome: Change From Baseline in Electrocardiogram Results (QTcF) at Tmax on Day 6

Time frame: Baseline and Tmax (time of subject-specific maximum plasma concentration). Least squares mean (Standard Error). Unit: msec

Measure	Guanfacine 8 mg n = 58	Moxifloxacin n = 45	Placebo (Guanfacine) n = 58	Placebo (Moxifloxacin) n = 44
Value	-2.67 (1.24)	6.44 (1.65)	-4.31 (1.25)	-4.35 (1.68)

Guanfacine 8 mg vs Placebo (Guanfacine): Mean Difference (Final Values): 1.64 (90% CI -0.99 to 4.27)
Moxifloxacin vs Placebo (Moxifloxacin): Mean Difference (Final Values): 10.80 (90% CI 7.63 to 13.97)

Population analysed: PD population

6 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Guanfacine	5 of 76 (6.6%)	76 of 76 (100%)	Not reported
Moxifloxacin	0 of 72 (0%)	46 of 72 (63.9%)	Not reported
Placebo	0 of 68 (0%)	39 of 68 (57.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25109412Martin 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.
FDA recall informationLink provided by the sponsor.
FDA-approved labelLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Study Director study director

Takeda

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing immediate release guanfacine hydrochloride and moxifloxacin in people with Healthy Volunteers, run by Shire at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Dec 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Electrocardiogram Results (QTcNi) at Time of Maximum Plasma Concentration (Tmax) on Day 1 (time frame: Baseline, Tmax (time of subject-specific maximum plasma concentration)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00672984, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2021.