Effect of External Heat on a Transdermal Granisetron Patch in Pharmacokinetics (PK) of Healthy Subjects

NCT01073696 | Completed Phase 1

• 2 other identifiers: 392MD/43/C2009-017036-40
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the effect of heat applied to a granisetron transdermal patch in healthy subjects.

Conditions

Healthy

Keywords

Sancuso; granisetron; Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetic profile of the granisetron patch in healthy subjects when heat is applied

  To assess the effect of locally applied heat on the pharmacokinetic profile of granisetron delivered from the patch. Subjects will be randomized to receive Treatment A Sancuso patch ONLY and Treatment B, Sancuso PLUS Cura-Heat pad. Sancuso will be worn by the subjects for 5 days continuously. The Cura-Heat pad will be applied over the patch for 4.5 hours on each of the 5 days. During these 5 days PK sampling is planned to measure the initial release of granisetron from the patch and cover the predicted maximum observed concentrations with or without the Cura-Heat pad in place.

  0 - 196 hours post dose

Secondary Outcomes (2)

• Safety and tolerability assessment

  Up to 23 days post dose

• residual granisetron after patch use in healthy subjects

  120 hours post dose

Study Arms (2)

granisetron IV

ACTIVE COMPARATOR

Drug: granisetron IV

granisetron patch

EXPERIMENTAL

Drug: granisetron patch

Interventions

granisetron IV DRUG

IV

granisetron IV

granisetron patch DRUG

patch

granisetron patch

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male or female subjects aged ≥ 18 and ≤ 45 years at screening. Subjects must demonstrate understanding of the purposes and risks of the study and agree to follow the restrictions and schedule of study procedures, as evidenced by voluntary written informed consent (signed and dated) obtained before taking part in any trial-related activities.

You may not qualify if:

• Any current or previous disease, disorder, allergy or condition (including recent unexplained weight loss) that could affect the study conduct or laboratory assessments, or that presents undue risk from the study medication or procedures. Hypersensitivity to adhesive plasters or surgical tape.
• Any physical examination or screening investigation result that indicates the subject is unfit for the study.
• Scarring on upper arms, including extensive tattoos making skin reactions unevaluable.
• A positive virology test, urine test for drugs of abuse, or pregnancy test result (females of childbearing potential only).
• Recent use of prescribed or over-the-counter medication that, in the opinion of the Investigator or the Sponsor, will interfere with the study procedures or compromise safety.
• Received an investigational drug within 3 months (90 days) preceding patch application.
• Loss of ≥ 400 mL of blood (e.g. been a blood donor) within the past 3 months.
• 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 patch application. Subjects may not smoke while confined to the study site. Subjects must not consume alcohol, or xanthine-containing foods or drinks within 48 hours prior to dosing until discharge.
• Lactating female subjects, and female subjects of childbearing potential who are not willing to use an acceptable form of contraception from the screening visit, during the study and for 90 days after the study.
• Employee of the Investigator or study centre, with direct involvement in the proposed study or other studies under the direction of that Investigator or study centre, as well as family members of the employees or the Investigator.

Sponsors & Collaborators

• Kyowa Kirin Co., Ltd.: lead

Study Sites (1)

Quotient Clinical Limited

Edinburgh, EH14 4AP, United Kingdom

Location

Study Officials

• Stuart J Mair

  Quotient Clinical Limited

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2010
• First Posted: February 23, 2010
• Study Start: March 1, 2010
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: June 17, 2024

Record last verified: 2024-06

Locations

GB (1)