PK, Tolerability and Safety of the Co-administration of Sancuso® (Transdermal Granisetron) and IV Granisetron

NCT00873197 | Completed Phase 1

• 1 other identifier: 392MD/41/C
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Co-administration of transdermal and intravenous granisetron; Granisetron; Healthy subjects; Intravenous; Pharmacokinetic profile; Sancuso® patch; Transdermal; Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetic profile of the co-administration of IV granisetron and the Sancuso® patch

  0 to 336 hours post-dose

Secondary Outcomes (3)

• Safety and tolerability of the coadministration of IV granisetron and the Sancuso® patch

  Up to 28 days post-dose

• Patch adhesion and residual granisetron after patch

  0 to 336 hours post-dose

• Pharmacokinetic profile of repeated Sancuso® patch application

  0 to 336 hours post-dose

Study Arms (1)

Sancuso® patch/IV granisetron

EXPERIMENTAL

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

Interventions

granisetron DRUG

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.

Also known as: Granisetron Transdermal System, Sancuso® patch, Kytril®, Granisetron Injection

Sancuso® patch/IV granisetron

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kyowa Kirin Co., Ltd.: lead

Study Sites (1)

Charles River Clinical Services Edinburgh Ltd

Edinburgh, EH33 2NE, United Kingdom

Location

MeSH Terms

Interventions

Granisetron

Intervention Hierarchy (Ancestors)

Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Stuart J Mair

  Syneos Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2009
• First Posted: April 1, 2009
• Study Start: April 1, 2009
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: June 17, 2024

Record last verified: 2024-06

Locations

GB (1)