PK, Tolerability and Safety of the co-Administration of Sancuso® (Transdermal Granisetron) and IV Granisetron

A Study to Assess the Pharmacokinetics, Tolerability and Safety of the co-Administration of Sancuso® (Transdermal Granisetron) and Intravenous Granisetron in Healthy Subjects

This study has been designed to investigate the pharmacokinetic and safety profile of the co-administration of intravenous (IV) and transdermal granisetron, as well as characterise the pharmacokinetics of multiple transdermal dosing.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: granisetron

Detailed Description

Sancuso® is designed to provide antiemetic prophylaxis for chemotherapy of up to 5 days duration. In exceptional clinical situations in which the patch is not applied at the appropriate time (i.e. 24-48 hours pre-chemotherapy), clinicians might use a single IV dose of granisetron to provide prophylaxis while the granisetron from the patch reaches a therapeutic plasma concentration.

Most chemotherapeutics are dosed in a single day, with a 2- or 3-week interval between doses; however, several regimens are administered over more than 5 days and others are given at frequencies (e.g. every 5 days). Thus, more than one patch may be required to provide continuous antiemetic prophylaxis. Characterisation of the pharmacokinetics of multiple transdermal dosing offers useful information for clinicians who treat patients with the latter types of regimens.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Edinburgh, United Kingdom, EH33 2NE
    • Charles River Clinical Services Edinburgh Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy male or female Caucasian subjects
• Aged between 18 and 70 years, inclusive, at screening
• BMI between 20.0 and 29.9 kg/m², inclusive.
• Must demonstrate understanding of the purposes and risks of the study
• Must agree to follow the restrictions and schedule of study procedures

Exclusion Criteria:

• Current or previous disease, disorder, allergy or condition that could affect study conduct or laboratory assessments, or that presents undue risk from study medication or procedures.
• Physical examination or screening investigation result that indicates subject is unfit for the study.
• Scarring on upper arms.
• Positive virology, urine drugs of abuse or pregnancy test result (females of childbearing potential only).
• Recent use of prescribed or over the counter medication.
• Participation in any clinical study or loss of ≥ 400 mL of blood (e.g. been a blood donor) within the previous 60 days.
• Average weekly alcohol consumption of greater than 21 units (males) or 14 units (females), or habitually smokes ≥ 5 cigarettes or equivalent tobacco per day within the 6 months before the first study drug administration.
• Lactating female subjects and female subjects of childbearing potential who are not willing to use an acceptable form of contraception during and for 90 days after the study.

Study Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Sancuso® patch/IV granisetron; Subjects will receive 1 Sancuso® patch worn for 7 days (168 hours). Immediately after the patch has been applied on Day 1, IV granisetron will be administered over 30 seconds. Following patch removal at 168 hours, a new patch will be immediately applied to the opposite arm and will remain in place for a further 7 days (168 to 336 hours).

Drug: granisetron; Sancuso® 3.1 mg/24 hours; transdermal. One patch applied to healthy intact skin on the upper outer arm and worn for 7 days (168 hours) followed by a second patch applied to the opposite arm at 168 hours for a further 7 days (168 to 336 hours). Kytril® (granisetron hydrochloride) 1 mg/mL; IV; 0.01 mg/kg (maximum 1 mg) administered over 30 seconds immediately following patch application on Day 1 only.; Other Names: Granisetron Transdermal System; Sancuso® patch; Kytril®; Granisetron Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetic profile of the co-administration of IV granisetron and the Sancuso® patch	0 to 336 hours post-dose

Secondary Outcome Measures

Outcome Measure	Time Frame
Safety and tolerability of the coadministration of IV granisetron and the Sancuso® patch	Up to 28 days post-dose
Patch adhesion and residual granisetron after patch	0 to 336 hours post-dose
Pharmacokinetic profile of repeated Sancuso® patch application	0 to 336 hours post-dose

Collaborators and Investigators

• Sponsor: Prostrakan Pharmaceuticals
• Investigators: Principal Investigator: Stuart J Mair, Syneos Health

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (Actual): May 1, 2009
• Study Completion (Actual): May 1, 2009

Study Registration Dates

• First Submitted: March 31, 2009
• First Submitted That Met QC Criteria: March 31, 2009
• First Posted (Estimate): April 1, 2009

Study Record Updates

• Last Update Posted (Estimate): May 4, 2009
• Last Update Submitted That Met QC Criteria: May 1, 2009
• Last Verified: May 1, 2009

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Transdermal; Healthy subjects; Granisetron; Intravenous; Pharmacokinetic profile; Co-administration of transdermal and intravenous granisetron; Sancuso® patch
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Serotonin Agents; Serotonin Antagonists; Granisetron
• Other Study ID Numbers: 392MD/41/C