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

This study has been completed.
Sponsor:
Information provided by:
Prostrakan Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00873197
First received: March 31, 2009
Last updated: May 1, 2009
Last verified: May 2009
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: granisetron
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Study to Assess the Pharmacokinetics, Tolerability and Safety of the co-Administration of Sancuso® (Transdermal Granisetron) and Intravenous Granisetron in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Prostrakan Pharmaceuticals:

Primary Outcome Measures:
  • Pharmacokinetic profile of the co-administration of IV granisetron and the Sancuso® patch [ Time Frame: 0 to 336 hours post-dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and tolerability of the coadministration of IV granisetron and the Sancuso® patch [ Time Frame: Up to 28 days post-dose ] [ Designated as safety issue: No ]
  • Patch adhesion and residual granisetron after patch [ Time Frame: 0 to 336 hours post-dose ] [ Designated as safety issue: No ]
  • Pharmacokinetic profile of repeated Sancuso® patch application [ Time Frame: 0 to 336 hours post-dose ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: April 2009
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00873197

Locations
United Kingdom
Charles River Clinical Services Edinburgh Ltd
Edinburgh, United Kingdom, EH33 2NE
Sponsors and Collaborators
Prostrakan Pharmaceuticals
Investigators
Principal Investigator: Stuart J Mair INC Research
  More Information

No publications provided

Responsible Party: Dr Bridget O'Mahony/Clinical Research Manager, Strakan Pharmaceuticals Ltd
ClinicalTrials.gov Identifier: NCT00873197     History of Changes
Other Study ID Numbers: 392MD/41/C
Study First Received: March 31, 2009
Last Updated: May 1, 2009
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Prostrakan Pharmaceuticals:
Co-administration of transdermal and intravenous granisetron
Granisetron
Healthy subjects
Intravenous
Pharmacokinetic profile
Sancuso® patch
Transdermal
Pharmacokinetics

Additional relevant MeSH terms:
Granisetron
Antiemetics
Autonomic Agents
Central Nervous System Agents
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Serotonin Agents
Serotonin Antagonists
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014