Phase 1
N=83
Guanfacine Immediate-release Electrocardiogram Results (QTc) Study
Healthy Volunteers
Bottom Line
View on ClinicalTrials.gov: NCT00672984 ↗Enrolled (actual)
83
Serious AEs
2.3%
Results posted
Dec 2009
Primary outcome: Primary: Change From Baseline in Electrocardiogram Results (QTcNi) at Time of Maximum Plasma Concentration (Tmax) on Day 1 — -3.37; 12.96; -0.94; -0.91 msec
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- immediate release guanfacine hydrochloride (Drug); moxifloxacin (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Shire
- Primary completion
- Aug 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Electrocardiogram Results (QTcNi) at Time of Maximum Plasma Concentration (Tmax) on Day 1 |
-3.37; 12.96; -0.94; -0.91 | — |
| PRIMARY Change From Baseline in Electrocardiogram Results (QTcNi) at Tmax on Day 6 |
-12.45; 8.99; -4.37; -4.13 | — |
| PRIMARY Change From Baseline in Electrocardiogram Results (QTcF) at Tmax on Day 1 |
0.15; 9.96; -0.83; -1.14 | — |
| PRIMARY Change From Baseline in Electrocardiogram Results (QTcF) at Tmax on Day 6 |
-2.67; 6.44; -4.31; -4.35 | — |
| PRIMARY Change From Baseline in Heart Rate (HR) at Tmax on Day 1 |
-7.18; 5.46; -0.42; 0.73 | — |
| PRIMARY Change From Baseline in Heart Rate (HR) at Tmax on Day 6 |
-19.74; 4.66; 0.11; 1.22 | — |
| PRIMARY Change From Baseline in Electrocardiogram Results (QT) Interval at Tmax on Day 1 |
15.88; -1.27; 0.56; -2.20 | — |
| PRIMARY Change From Baseline in Electrocardiogram Results (QT) Interval at Tmax on Day 6 |
46.21; -3.09; -3.63; -6.71 | — |
| SECONDARY Maximum Plasma Concentration (Cmax) of Guanfacine and Moxifloxacin on Day 1 |
8.51; 1943.1 | — |
| SECONDARY Maximum Plasma Concentration (Cmax) of Guanfacine and Moxifloxacin on Day 6 |
24.70; 2003.4 | — |
| SECONDARY Time of Maximum Plasma Concentration (Tmax) of Guanfacine and Moxifloxacin on Day 1 |
3.9; 2.13 | — |
| SECONDARY Time of Maximum Plasma Concentration (Tmax) of Guanfacine and Moxifloxacin on Day 6 |
5.2; 1.78 | — |
| SECONDARY Area Under the Steady-state Plasma Concentration-time Curve (AUC) for Guanfacine and Moxifloxacin on Day 1 |
110.8; 19892 | — |
| SECONDARY Area Under the Steady-state Plasma Concentration-time Curve (AUC) for Guanfacine and Moxifloxacin on Day 6 |
370.3; 20767 | — |
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
Eligibility Criteria
Inclusion Criteria
- Healthy Normal Subjects
Data sourced from ClinicalTrials.gov (NCT00672984). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.