Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of Granisetron Hydrochloride Nasal Spray (GNS) in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02563951
Recruitment Status : Completed
First Posted : September 30, 2015
Last Update Posted : January 8, 2016
Sponsor:
Collaborator:
Tri-Service General Hospital
Information provided by (Responsible Party):
Maxinase Life Sciences Ltd.

Brief Summary:
The purpose of this study is to examine the pharmacokinetics (PK), safety and tolerability of 3 intranasal (IN) doses (0.5, 1.0 and 2.0 mg) of Granisetron Hydrochloride Nasal Sprays (GNS) as compared to Granisetron IV Injection and Granisetron Tablet in healthy Volunteers.

Condition or disease Intervention/treatment Phase
Cancer Drug: GNS Spray 0.5mg Drug: GNS Spray 1.0mg Drug: GNS Spray 2.0mg Drug: Kytril 1mg (IV injection) Drug: Kytril 1mg (Tablet) Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Pharmacokinetic Study of Granisetron Hydrochloride Nasal Spray (GNS) in Healthy Volunteers
Study Start Date : September 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: GNS Spray 0.5mg
One spray of GNS 0.5mg/spray into right nostril.
Drug: GNS Spray 0.5mg
Other Name: Granisetron Nasal Spray

Experimental: GNS Spray 1.0mg
One spray of GNS 0.5mg/spray into both left and right nostril.
Drug: GNS Spray 1.0mg
Other Name: Granisetron Nasal Spray

Experimental: GNS Spray 2.0mg
One spray of GNS 1.0mg/spray into both left and right nostril.
Drug: GNS Spray 2.0mg
Other Name: Granisetron Nasal Spray

Active Comparator: Kytril 1mg (IV injection)
A dose of 1mg of Granisetron IV injection (kytril 1mL, 3mg/mL/vial) will be administered as a slow IV injection (over 30 seconds)
Drug: Kytril 1mg (IV injection)
Other Name: Granisetron

Active Comparator: Kytril 1mg (Tablet)
a single dose (kytril 1mg, one tablet) orally administered with 240mL of water
Drug: Kytril 1mg (Tablet)
Other Name: Granisetron




Primary Outcome Measures :
  1. PK Parameter: Area under the plasma concentration-time curve from zero (0) hours to infinity (∞) (AUC(0-∞)) for 3 intranasal (IN) doses (0.5, 1.0 and 2.0 mg) of GNS and Granisetron IV Injection [ Time Frame: within 1 hour prior to drug administration; 5, 10, 15, 20, 30, 45 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours post-dose. ]
  2. PK Parameter: Area under the plasma concentration-time curve from zero (0) hours to last quantifiable concentration(t) (AUC(0-t)) for 3 intranasal (IN) doses (0.5, 1.0 and 2.0 mg) of GNS and Granisetron IV Injection [ Time Frame: within 1 hour prior to drug administration; 5, 10, 15, 20, 30, 45 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours post-dose. ]
  3. PK Parameter: Peak Plasma Concentration (Cmax) for 3 intranasal (IN) doses (0.5, 1.0 and 2.0 mg) of GNS and Granisetron IV Injection [ Time Frame: within 1 hour prior to drug administration; 5, 10, 15, 20, 30, 45 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours post-dose. ]
  4. PK Parameter: Area under the plasma concentration-time curve from zero (0) hours to infinity (∞) (AUC(0-∞)) for Granisetron Tablet [ Time Frame: within 1 hour prior to drug administration; 15, 30, 45 minutes, and 1, 1.33, 1.66, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 and 36 hours post-dose ]
  5. PK Parameter: Area under the plasma concentration-time curve from zero (0) hours to last quantifiable concentration (t) (AUC(0-t)) for Granisetron Tablet [ Time Frame: within 1 hour prior to drug administration; 15, 30, 45 minutes, and 1, 1.33, 1.66, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 and 36 hours post-dose ]
  6. PK Parameter: Peak Plasma Concentration (Cmax) for Granisetron Tablet [ Time Frame: within 1 hour prior to drug administration; 15, 30, 45 minutes, and 1, 1.33, 1.66, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 and 36 hours post-dose ]

Secondary Outcome Measures :
  1. PK Parameter: Time to maximum plasma concentration (Tmax) for 3 intranasal (IN) doses (0.5, 1.0 and 2.0 mg) of Granisetron Hydrochloride Nasal Sprays (GNS) and Granisetron IV Injection [ Time Frame: within 1 hour prior to drug administration; 5, 10, 15, 20, 30, 45 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours post-dose. ]
  2. PK Parameter: Time to maximum plasma concentration (Tmax) for Granisetron Tablet [ Time Frame: within 1 hour prior to drug administration; 15, 30, 45 minutes, and 1, 1.33, 1.66, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 and 36 hours post-dose ]
  3. PK Parameter: elimination constant rate (Kel) for 3 intranasal (IN) doses (0.5, 1.0 and 2.0 mg) of Granisetron Hydrochloride Nasal Sprays (GNS) and Granisetron IV Injection [ Time Frame: within 1 hour prior to drug administration; 5, 10, 15, 20, 30, 45 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours post-dose. ]
  4. PK Parameter: elimination constant rate (Kel) for Granisetron Tablet [ Time Frame: within 1 hour prior to drug administration; 15, 30, 45 minutes, and 1, 1.33, 1.66, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 and 36 hours post-dose ]
  5. PK Parameter: half-life (t1/2) for 3 intranasal (IN) doses (0.5, 1.0 and 2.0 mg) of Granisetron Hydrochloride Nasal Sprays (GNS) and Granisetron IV Injection [ Time Frame: within 1 hour prior to drug administration; 5, 10, 15, 20, 30, 45 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours post-dose. ]
  6. PK Parameter: half-life (t1/2) for Granisetron Tablet [ Time Frame: within 1 hour prior to drug administration; 15, 30, 45 minutes, and 1, 1.33, 1.66, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 and 36 hours post-dose ]
  7. PK Parameter: absolute bioavailability (F) for 3 intranasal (IN) doses (0.5, 1.0 and 2.0 mg) of Granisetron Hydrochloride Nasal Sprays (GNS) and Granisetron IV Injection [ Time Frame: within 1 hour prior to drug administration; 5, 10, 15, 20, 30, 45 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours post-dose. ]
  8. PK Parameter: absolute bioavailability (F) for Granisetron Tablet [ Time Frame: within 1 hour prior to drug administration; 15, 30, 45 minutes, and 1, 1.33, 1.66, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 and 36 hours post-dose ]
  9. Report adverse events and measure vital signs over trial period. [ Time Frame: These will be measured from 30 mins pre-dose to every 3 hours until 12 hours post-dose, then at 24 and 36 hours post-dose ]
  10. 12-Lead ECG assessment [ Time Frame: This will be measured at screening, and 24, 36 hours post-dose. ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy males or females between the ages of 20-64 years
  2. Body Mass Index (BMI) of 18.5 (inclusive) to 24 kg/m2; and a total body weight >45 kg
  3. Accessible vein for blood sampling
  4. No significant abnormalities in electrocardiogram (ECG) recording as per sites' local practice
  5. No significant abnormalities in general physical examination as per sites' local practice
  6. No significantly abnormal findings in laboratory assessments including hematology, biochemistry and urinalysis as per site's local practice
  7. A signed and dated written informed consent must be obtained from the subject prior to study participation
  8. Capable of understanding and willing to comply with study procedures
  9. A negative serum pregnancy test before the first dose of study drug must be available for women of childbearing potential

Exclusion Criteria:

  1. Females who are pregnant, breast-feeding or have positive pregnancy test
  2. History of hypersensitivity to granisetron or its analogs
  3. Subjects with nasal ulcer, septal perforation, or other nasal conditions that may interfere with nasal administration and determined by the investigator to be ineligible
  4. Subjects with a QT interval greater than 500 ms or with acute ischemic changes or cardiac abnormality predisposing to arrhythmia on screening electrocardiogram (ECG) or by history
  5. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or other significant disease or clinical findings at screening and determined by the investigator to be ineligible
  6. Subjects with a history of drug and/or alcohol abuse within 12 months prior to dosing
  7. Inability to read and/or sign the consent form
  8. Treatment with any other investigational drug during the 4 weeks prior to the initial dosing for this study
  9. Subjects who have donated or lost more than 250 ml blood within 2 months prior to the initial dosing for this study
  10. Male and female subjects with reproductive potential who are not willing to use effective method of contraception. Use of hormonal contraceptive is not allowed during the study period
  11. Clinical significant rhinitis or rhinorrhea at screening determined by the investigator to be ineligible
  12. Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to dosing of study medication
  13. For subjects who smoke or use tobacco products or are currently using nicotine products (patches, gums, etc.), 2 weeks abstinence is required
  14. Conditions upon screening which might contraindicate or require that caution be used in the administration of granisetron

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02563951


Locations
Layout table for location information
Taiwan
Tri-Service General Hospital
Neihu District, Taipei City, Taiwan, 114
Sponsors and Collaborators
Maxinase Life Sciences Ltd.
Tri-Service General Hospital
Investigators
Layout table for investigator information
Principal Investigator: Kai-Min Chu, M.D Ph.D. Tri-Service General Hospital
Layout table for additonal information
Responsible Party: Maxinase Life Sciences Ltd.
ClinicalTrials.gov Identifier: NCT02563951    
Other Study ID Numbers: GNS-CL001
First Posted: September 30, 2015    Key Record Dates
Last Update Posted: January 8, 2016
Last Verified: January 2016
Keywords provided by Maxinase Life Sciences Ltd.:
Nausea
Vomiting
Chemotherapy
Radiation therapy
Additional relevant MeSH terms:
Layout table for MeSH terms
Granisetron
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action