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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 2009

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • 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).

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Prostrakan Pharmaceuticals
  • Provider of Information About this Clinical Study
    • Dr Bridget O’Mahony/Clinical Research Manager, Strakan Pharmaceuticals Ltd
  • Overall Official(s)
    • Stuart J Mair, Principal Investigator, Syneos Health

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