Safety Study of Electrocardiogram (ECG) Effects of Sancuso® (Granisetron TDS)

NCT00890565 | Completed Phase 1

• 1 other identifier: 392MD/39/C
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the electrocardiogram (ECG) effects of Sancuso® compared to placebo and moxifloxacin in healthy subjects.

Conditions

Healthy

Keywords

Electrocardiogram; Effect on electrocardiogram; Granisetron; Moxifloxacin; Pharmacokinetic profile; Sancuso® patch; Transdermal

Outcome Measures

Primary Outcomes (1)

• Time-matched, placebo-corrected change from baseline in QTc based on the Fridericia correction (QTcF).

  0 to 120 hours post-dose

Secondary Outcomes (3)

• QTc with Bazett correction (QTcB), heart rate, PR interval, QRS interval, uncorrected QT interval, change in ECG morphological patterns and correlation between the QTcF change from baseline and plasma granisetron concentrations

  0 to 120 hours post-dose

• Relationship of plasma concentration of granisetron versus QTcF, both graphical and mixed effects analyses of plasma concentration of granisetron versus QTcF will be performed

  0 to 120 hours post-dose

• Patch adhesion and residual granisetron after patch use.

  0 to 120 hours post-dose

Study Arms (4)

Treatment A: Sancuso® patch

EXPERIMENTAL

Treatment A: Sancuso® patch (Day 1) and placebo IV (Day 3)

Drug: granisetron

Treatment B: IV Granisetron 10 mcg/kg

EXPERIMENTAL

Treatment B: placebo patch (Day 1) and granisetron IV (Day 3)

Drug: granisetron

Treatment C: Matching placebo patch

PLACEBO COMPARATOR

Treatment C: placebo patch (Day 1) and placebo IV (Day 3)

Drug: granisetron

Treatment D: Oral Moxifloxacin 400 mg

ACTIVE COMPARATOR

Treatment D: placebo patch (Day 1) and oral moxifloxacin (Day 3).

Drug: granisetron

Interventions

granisetron DRUG

Treatment A: Sancuso® patch (3.1mg/24 hours) on Day 1 and IV placebo (0.9% saline) on Day 3 Treatment B: Granisetron IV 10 mcg/kg over 30 seconds on Day 1 and placebo patch on Day 3 Treatment C: Placebo patch on Day 1 and IV placebo on Day 3 Treatment D: 400 mg oral moxifloxacin on Day 1 and placebo patch on Day 3

Also known as: Granisetron Transdermal System, Sancuso® patch, Kytril®, Granisetron Injection, IV Placebo (0.9% saline), Placebo patches, Avelox® Oral

Treatment A: Sancuso® patch; Treatment B: IV Granisetron 10 mcg/kg; Treatment C: Matching placebo patch; Treatment D: Oral Moxifloxacin 400 mg

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male or female subjects
• Aged between 18 and 50 years, inclusive, at screening
• BMI between 18.0 and 32.0 kg/m², inclusive

You may not qualify if:

• History of drug abuse
• Known hypersensitivity to granisetron, moxifloxacin, or related compounds, such as ciprofloxacin and levofloxacin
• Sustained supine systolic blood pressure \>140 mmHg or \<100 mmHg or a diastolic blood pressure \>95 mmHg at Screening or baseline
• Pulse rate at rest of \< 45 bpm or \> 100 bpm
• Abnormal Screening ECG indicating a second- or third degree AV block, or one or more of the following: QRS \>120 milliseconds (ms); QTcF \> 430 (males) or 450 (females) ms; PR interval \>240 ms; any rhythm, other than sinus rhythm, interpreted to be clinically significant by the Investigator
• Known history of long-QT syndrome, angina, myocardial ischemia or infarction, congestive heart failure, myocarditis, chest pain or dyspnea on exertion
• Electrolyte disturbances (such as uncorrected hypokalemia/hyperkalemia, hypomagnesemia, hypocalcemia, or hypophosphatemia), idiopathic cardiomyopathy, unexplained syncope, hypertrophic cardiomyopathy, or sudden unexplained death at a young age (\< 40 years) in a first-degree relative.
• Has used any medications or consumed any foods contraindicated in the protocol.

Sponsors & Collaborators

• Kyowa Kirin Co., Ltd.: lead

Study Sites (1)

Spaulding Clinical Research, LLC

West Bend, Wisconsin, 53095, United States

Location

MeSH Terms

Interventions

Granisetron; Sodium Chloride; Moxifloxacin

Intervention Hierarchy (Ancestors)

Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines

Study Officials

• Bridget O'Mahony, PhD

  Kyowa Kirin Co., Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2009
• First Posted: April 30, 2009
• Study Start: May 1, 2009
• Primary Completion: August 1, 2009
• Study Completion: September 1, 2009
• Last Updated: June 17, 2024

Record last verified: 2024-06

Locations

US (1)