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CancerPhase 1NCT02563951

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

A Phase 1 study testing GNS Spray 0.5mg, GNS Spray 1.0mg and GNS Spray 2.0mg in people with Cancer, run by Maxinase Life Sciences Ltd. at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 64 yearsHealthy volunteers can take part
Conditions the study is for
Cancer
What is being tested?
GNS Spray 0.5mg, GNS Spray 1.0mg and GNS Spray 2.0mg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteTaiwan
Study dates
Sep 2015to Dec 2015
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 64 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

  • Females who are pregnant, breast-feeding or have positive pregnancy test
  • History of hypersensitivity to granisetron or its analogs
  • Subjects with nasal ulcer, septal perforation, or other nasal conditions that may interfere with nasal administration and determined by the investigator to be ineligible
  • 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
  • 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
  • Subjects with a history of drug and/or alcohol abuse within 12 months prior to dosing
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  • Inability to read and/or sign the consent form
  • Treatment with any other investigational drug during the 4 weeks prior to the initial dosing for this study
  • Subjects who have donated or lost more than 250 ml blood within 2 months prior to the initial dosing for this study
  • 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
  • Clinical significant rhinitis or rhinorrhea at screening determined by the investigator to be ineligible
  • 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
  • For subjects who smoke or use tobacco products or are currently using nicotine products (patches, gums, etc.), 2 weeks abstinence is required
  • Conditions upon screening which might contraindicate or require that caution be used in the administration of granisetron

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Tri-Service General Hospital

    Neihu District, Taipei City, 114

Other trials in Taiwan

About this study

Official title: A Phase I Pharmacokinetic Study of Granisetron Hydrochloride Nasal Spray (GNS) in Healthy Volunteers

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
Being tested
GNS Spray 0.5mg, GNS Spray 1.0mg, GNS Spray 2.0mg, Kytril 1mg (IV injection), Kytril 1mg (Tablet)
Keywords
Nausea, Vomiting, Chemotherapy, Radiation therapy
Medical subject headings
Neoplasms, Nausea, Vomiting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GNS Spray 0.5mgDrug

    Also called Granisetron Nasal Spray

  • GNS Spray 1.0mgDrug

    Also called Granisetron Nasal Spray

  • GNS Spray 2.0mgDrug

    Also called Granisetron Nasal Spray

  • Kytril 1mg (IV injection)Drug

    Also called Granisetron

  • Kytril 1mg (Tablet)Drug

    Also called Granisetron

Study groups in NCT02563951
Study groupRoleWhat they receive
GNS Spray 0.5mgExperimentalOne spray of GNS 0.5mg/spray into right nostril.
Receives: Drug: GNS Spray 0.5mg
GNS Spray 1.0mgExperimentalOne spray of GNS 0.5mg/spray into both left and right nostril.
Receives: Drug: GNS Spray 1.0mg
GNS Spray 2.0mgExperimentalOne spray of GNS 1.0mg/spray into both left and right nostril.
Receives: Drug: GNS Spray 2.0mg
Kytril 1mg (IV injection)Active comparatorA dose of 1mg of Granisetron IV injection (kytril 1mL, 3mg/mL/vial) will be administered as a slow IV injection (over 30 seconds)
Receives: Drug: Kytril 1mg (IV injection)
Kytril 1mg (Tablet)Active comparatora single dose (kytril 1mg, one tablet) orally administered with 240mL of water
Receives: Drug: Kytril 1mg (Tablet)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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 outcomes (10)

  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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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.

    Measured: 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

    Measured: This will be measured at screening, and 24, 36 hours post-dose.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Sep 2015 (estimated)
  2. Study startSep 2015
  3. Primary completionDec 2015
  4. Study completionDec 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02563951
Sponsor's protocol ID
GNS-CL001
Status last verified
Jan 2016
First submitted
16 Sep 2015
Last updated
8 Jan 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GNS Spray 0.5mg, GNS Spray 1.0mg and GNS Spray 2.0mg in people with Cancer, run by Maxinase Life Sciences Ltd. at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02563951.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2016.

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