Effect of External Heat on a Transdermal Granisetron Patch in Pharmacokinetics (PK) of Healthy Subjects
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 IV (Drug); granisetron patch (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Prostrakan Pharmaceuticals Official(s) and/or principal investigator(s): Stuart J Mair, Principal Investigator, Affiliation: Quotient Clinical Limited
Summary
The purpose of this study is to determine the effect of heat applied to a granisetron
transdermal patch in healthy subjects.
Clinical Details
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 design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Pharmacokinetic profile of the granisetron patch in healthy subjects when heat is applied
Secondary outcome: Safety and tolerability assessmentresidual granisetron after patch use in healthy subjects
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Both.
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.
Locations and Contacts
Quotient Clinical Limited, Origo Centre, Riccarton, Edinburgh EH14 4AP, United Kingdom
Additional Information
Starting date: March 2010
Last updated: September 24, 2010
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