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

March 31, 2009
May 1, 2009
April 2009
May 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00873197 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 1
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Healthy
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
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).
Intervention: Drug: granisetron
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
May 2009
May 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00873197
392MD/41/C
No
Dr Bridget O'Mahony/Clinical Research Manager, Strakan Pharmaceuticals Ltd
Prostrakan Pharmaceuticals
Not Provided
Principal Investigator: Stuart J Mair INC Research
Prostrakan Pharmaceuticals
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP