Clinical trial NCT01073696: Effect of External Heat on a Transdermal Granisetron Patch in Pharmacokinetics (PK) of Healthy Subjects
Official title: A Phase I Study to Evaluate the Effect of External Heat on the Pharmacokinetics of a Transdermal Granisetron Patch in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Sancuso
granisetron
Pharmacokinetics
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2010-02-23
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Pharmacokinetic profile of the granisetron patch in healthy subjects when heat is applied
timeFrame: 0 - 196 hours post dose
Secondary outcomes:
measure: Safety and tolerability assessment
timeFrame: Up to 23 days post dose
measure: residual granisetron after patch use in healthy subjects
timeFrame: 120 hours post dose
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: Quotient Clinical Limited
Study officials:
affiliation: Quotient Clinical Limited
name: Stuart J Mair
role: PRINCIPAL_INVESTIGATOR
References: