Clinical trial NCT00873197: PK, Tolerability and Safety of the Co-administration of Sancuso® (Transdermal Granisetron) and IV Granisetron
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Co-administration of transdermal and intravenous granisetron
Granisetron
Healthy subjects
Intravenous
Pharmacokinetic profile
Sancuso® patch
Transdermal
Pharmacokinetics
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2009-04-01
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.

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 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.

Primary outcomes:
measure: Pharmacokinetic profile of the co-administration of IV granisetron and the Sancuso® patch
timeFrame: 0 to 336 hours post-dose
Secondary outcomes:
measure: Safety and tolerability of the coadministration of IV granisetron and the Sancuso® patch
timeFrame: Up to 28 days post-dose
measure: Patch adhesion and residual granisetron after patch
timeFrame: 0 to 336 hours post-dose
measure: Pharmacokinetic profile of repeated Sancuso® patch application
timeFrame: 0 to 336 hours post-dose
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: Charles River Clinical Services Edinburgh Ltd
Study officials:
affiliation: Syneos Health
name: Stuart J Mair
role: PRINCIPAL_INVESTIGATOR
References: