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

NCT ID: NCT01073696

Last Updated: 2024-06-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2010-04-30

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

granisetron IV

Group Type: ACTIVE_COMPARATOR

granisetron IV

Intervention Type: DRUG

IV

granisetron patch

Group Type: EXPERIMENTAL

granisetron patch

Intervention Type: DRUG

patch

Interventions

granisetron IV

IV

Intervention Type: DRUG

granisetron patch

patch

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kyowa Kirin Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stuart J Mair

Role: PRINCIPAL_INVESTIGATOR

Quotient Clinical Limited

Locations

Quotient Clinical Limited

Edinburgh, , United Kingdom

Countries

United Kingdom

Other Identifiers

2009-017036-40

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

392MD/43/C

Identifier Type: -

Identifier Source: org_study_id