PK, Tolerability and Safety of the co-Administration of Sancuso� (Transdermal Granisetron) and IV Granisetron
Information source: Prostrakan Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: granisetron (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Prostrakan Pharmaceuticals Official(s) and/or principal investigator(s): Stuart J Mair, Principal Investigator, Affiliation: INC Research
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.
Clinical Details
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 design: Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label
Primary outcome: Pharmacokinetic profile of the co-administration of IV granisetron and the Sancuso® patch
Secondary outcome: Safety and tolerability of the coadministration of IV granisetron and the Sancuso® patchPatch adhesion and residual granisetron after patch Pharmacokinetic profile of repeated Sancuso® patch application
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
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
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.
Locations and Contacts
Charles River Clinical Services Edinburgh Ltd, Edinburgh EH33 2NE, United Kingdom
Additional Information
Starting date: April 2009
Last updated: May 1, 2009
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