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

This study has been completed.
Sponsor:
Information provided by:
Prostrakan Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01073696
First received: February 16, 2010
Last updated: September 24, 2010
Last verified: February 2010
  Purpose

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


Condition Intervention Phase
Healthy
Drug: granisetron IV
Drug: granisetron patch
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study to Evaluate the Effect of External Heat on the Pharmacokinetics of a Transdermal Granisetron Patch in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Prostrakan Pharmaceuticals:

Primary Outcome Measures:
  • Pharmacokinetic profile of the granisetron patch in healthy subjects when heat is applied [ Time Frame: 0 - 196 hours post dose ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Safety and tolerability assessment [ Time Frame: Up to 23 days post dose ] [ Designated as safety issue: Yes ]
    Safety and tolerability will be assessed by collection of adverse events, safety laboratory assessments, record of vital signs, conduct of physical examination and 12 lead ECG. In addition skin reaction at the patch and Cura-Heat pad application sites will be monitored.

  • residual granisetron after patch use in healthy subjects [ Time Frame: 120 hours post dose ] [ Designated as safety issue: No ]
    • Residual granisetron after patch use and the calculation of in-vitro flux will be measured. All used patches will be returned to the manufacturer who will measure the amount of remaining granisetron in the patch and then the in-vitro flux will be calculated as follows: Amount delivered(assay amount-residual)/ number of days the patch was applied to the skin


Enrollment: 16
Study Start Date: March 2010
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: granisetron IV Drug: granisetron IV
IV
Experimental: granisetron patch Drug: granisetron patch
patch

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01073696

Locations
United Kingdom
Quotient Clinical Limited
Origo Centre, Riccarton, Edinburgh, United Kingdom, EH14 4AP
Sponsors and Collaborators
Prostrakan Pharmaceuticals
Investigators
Principal Investigator: Stuart J Mair Quotient Clinical Limited
  More Information

No publications provided

Responsible Party: Dr. Stuart J Mair, Quotient Clinical LImited
ClinicalTrials.gov Identifier: NCT01073696     History of Changes
Other Study ID Numbers: 392MD/43/C, 2009-017036-40
Study First Received: February 16, 2010
Last Updated: September 24, 2010
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Prostrakan Pharmaceuticals:
Sancuso
granisetron
Pharmacokinetics

Additional relevant MeSH terms:
Granisetron
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014