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

NCT ID: NCT02563951

Last Updated: 2016-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2015-12-31

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.

Conditions

Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

GNS Spray 0.5mg

One spray of GNS 0.5mg/spray into right nostril.

Group Type: EXPERIMENTAL

GNS Spray 0.5mg

Intervention Type: DRUG

GNS Spray 1.0mg

One spray of GNS 0.5mg/spray into both left and right nostril.

Group Type: EXPERIMENTAL

GNS Spray 1.0mg

Intervention Type: DRUG

GNS Spray 2.0mg

One spray of GNS 1.0mg/spray into both left and right nostril.

Group Type: EXPERIMENTAL

GNS Spray 2.0mg

Intervention Type: DRUG

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)

Group Type: ACTIVE_COMPARATOR

Kytril 1mg (IV injection)

Intervention Type: DRUG

Kytril 1mg (Tablet)

a single dose (kytril 1mg, one tablet) orally administered with 240mL of water

Group Type: ACTIVE_COMPARATOR

Kytril 1mg (Tablet)

Intervention Type: DRUG

Interventions

GNS Spray 0.5mg

Intervention Type: DRUG

GNS Spray 1.0mg

Intervention Type: DRUG

GNS Spray 2.0mg

Intervention Type: DRUG

Kytril 1mg (IV injection)

Intervention Type: DRUG

Kytril 1mg (Tablet)

Intervention Type: DRUG

Other Intervention Names

Granisetron Nasal Spray; Granisetron Nasal Spray; Granisetron Nasal Spray; Granisetron; Granisetron

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tri-Service General Hospital

OTHER

Sponsor Role: collaborator

Maxinase Life Sciences Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kai-Min Chu, M.D Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Tri-Service General Hospital

Locations

Tri-Service General Hospital

Neihu District, Taipei City, Taiwan

Countries

Taiwan

Other Identifiers

GNS-CL001

Identifier Type: -

Identifier Source: org_study_id