HealthyPhase 1NCT01572012
Phase 1 Safety, Tolerability and PK Study of Ondansetron and Hylenex Recombinant in Healthy Volunteers
A Phase 1 study testing Ondansetron, Ondansetron + Hylenex and Zofran ODT in people with Healthy, run by Halozyme Therapeutics at 1 site in United States.
Trial summary
This is a randomized, open-label Phase 1 pharmacokinetic, tolerability, and safety study of ondansetron and Hylenex given subcutaneously compared to ondansetron given intravenously, intramuscularly, and orally in normal healthy volunteers. Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Ondansetron, Ondansetron + Hylenex and Zofran ODT
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Nov 2013
- 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 19 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female volunteers 19-65 years old
- Females must be nonlactating and nonpregnant (negative serum pregnancy test at screening)and agree to practice effective birth control for at least 30 days after study completion
- Nonsmoker or no tobacco/nicotine use in previous 6 months
- Intact normal skin without obscuring tattoos, pigmentation or lesions
- Adequate venous access in upper extremities
- Normal vital signs, ECG, and labs or assessed by the Investigator as NCS
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- Serum hemoglobin within site's normal range
- Negative drug and alcohol screen
- Able to make decisions and comply with study requirements
Who cannot join
- History of drug or alcohol abuse or positive drug and alcohol screen
- Abdominal surgery within the last 30 days
- Phenylketonuria
- Tobacco or nicotine use within previous 6 months
- Hypersensitivity or contraindication to ondansetron or other 5-HT3 receptor agonists
- Received ondansetron within 4 days prior to Day 1
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- Known allergy to hyaluronidase or other ingredient in Hylenex recombinant
- Lower extremity edema
- Creatinine clearance < 60 mL/min
- Dehydration (Grade 2 or higher)
- Hypersensitivity or contraindication to heparin
- Abnormal ECG with clinically significant QT prolongation or history of
- Female who is pregnant or breastfeeding
- Participation in a clinical trial (drug or device) within 30 days of enrollment
- Clinically significant medical history, major systemic disease, intercurrent illness, physical examination finding, or clinical laboratory test result that risks the subject's safety or interfere with interpretation of study results
- Not able to comply with study requirements
Trial locations and contacts
1 site in 1 country.
United States1 site
Icon Development Solutions
San Antonio, Texas, 78209
About this study
Official title: Phase 1 Open-Label Randomized 4 Period Crossover Study Comparing Safety, Tolerability and PK of Ondansetron Given Subcutaneously With Hylenex Recombinant and Given Alone Intramuscularly, Intravenously and Orally in Healthy Volunteers
This is a randomized, open-label Phase 1 pharmacokinetic, tolerability, and safety study of ondansetron and Hylenex given subcutaneously compared to ondansetron given intravenously, intramuscularly, and orally in normal healthy volunteers.
Read the detailed description
This is a randomized, open label, 4 way crossover Phase 1 study of the pharmacokinetics, safety and tolerability of a 4 mg dose of ondansetron administered subcutaneously with Hylenex recombinant compared to 4 mg doses of ondansetron administered intravenously and intramuscularly and an 8 mg dose of ondansetron administered orally.
- Conditions
- Healthy
- Being tested
- Ondansetron, Ondansetron + Hylenex, Zofran ODT, Ondansetron solution
- Keywords
- Pharmacokinetics, Safety, Healthy Volunteers, tolerability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OndansetronDrug
Also called Zofran
Ondansetron solution 4 mg single administration
Ondansetron + HylenexDrug
Also called Zofran
Ondansetron solution (4 mg) single administration + Hylenex recombinant (150 U) single administration
Zofran ODTDrug
Also called ondansetron disintegrating tablet - oral
Zofran ODT (8 mg) single administration
Ondansetron solutionDrug
Also called Zofran
Ondansetron solution (4 mg) single administration
| Study group | Role | What they receive |
|---|---|---|
| Subcutaneous Administration | Experimental | Ondansetron + Hylenex administered subcutaneously Receives: Drug: Ondansetron + Hylenex |
| Oral Administration | Experimental | Ondansetron administered orally Receives: Drug: Zofran ODT |
| Intramuscular Administration | Experimental | Ondansetron administered intramuscularly Receives: Drug: Ondansetron |
| Intravenous Administration | Experimental | Ondansetron administered intravenously Receives: Drug: Ondansetron solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Overall Safety
Investigator assessment of infusion site observations for parenteral administration; Subject assessment of pain using the verbal response scale for parenteral administration; Subject assessment of pain using the visual analog scale for parenteral administration; Investigator assessment of systemic adverse events
Measured: Days 1-31
Secondary outcomes (1)
Evaluation of Pharmacokinetics
Area of under the plasma concentration time curve (AUC); Time to achieve maximum plasma concentration (tmax); Maximum plasma concentration (Cmax); Plasma elimination half-life (t1/2); Relative bioavailability, ondansentron SC with Hylenex recombinant relative to ondansetron alone IV, IM, and PO
Measured: Days 1-5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2012 (estimated)
- Study startFeb 2012
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Halozyme Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Samuel S Dychter, MD, Study director, Halozyme Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01572012
- Sponsor's protocol ID
- HALO-102-102
- Status last verified
- Jan 2014
- First submitted
- 3 Apr 2012
- Last updated
- 24 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Dychter SS, Harrigan R, Bahn JD, Printz MA, Sugarman BJ, DeNoia E, Haughey DB, Fellows D, Maneval DC. Tolerability and pharmacokinetic properties of ondansetron administered subcutaneously with recombinant human hyaluronidase in minipigs and healthy volunteers. Clin Ther. 2014 Feb 1;36(2):211-24. doi: 10.1016/j.clinthera.2013.12.013. Epub 2014 Jan 31.
PubMed 24486335
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Open-Label Randomized 4 Period Crossover Study Comparing Safety, Tolerability and PK of Ondansetron Given Subcutaneously With Hylenex Recombinant and Given Alone Intramuscularly, Intravenously and Orally in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01572012
- Acronym / sponsor ID
- HALO-102-102
- Conditions
- Healthy
- Keywords
- Pharmacokinetics, Safety, Healthy Volunteers, tolerability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Halozyme TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 5 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, open-label Phase 1 pharmacokinetic, tolerability, and safety study of ondansetron and Hylenex given subcutaneously compared to ondansetron given intravenously, intramuscularly, and orally in normal healthy volunteers.
Detailed description
This is a randomized, open label, 4 way crossover Phase 1 study of the pharmacokinetics, safety and tolerability of a 4 mg dose of ondansetron administered subcutaneously with Hylenex recombinant compared to 4 mg doses of ondansetron administered intravenously and intramuscularly and an 8 mg dose of ondansetron administered orally.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Subcutaneous Administration | Experimental | Drug: Ondansetron + HylenexOndansetron + Hylenex administered subcutaneously |
| Oral Administration | Experimental | Drug: Zofran ODTOndansetron administered orally |
| Intramuscular Administration | Experimental | Drug: OndansetronOndansetron administered intramuscularly |
| Intravenous Administration | Experimental | Drug: Ondansetron solutionOndansetron administered intravenously |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female volunteers 19-65 years old
- Females must be nonlactating and nonpregnant (negative serum pregnancy test at screening)and agree to practice effective birth control for at least 30 days after study completion
- Nonsmoker or no tobacco/nicotine use in previous 6 months
- Intact normal skin without obscuring tattoos, pigmentation or lesions
- Adequate venous access in upper extremities
Key exclusion criteria (16 listed)
- History of drug or alcohol abuse or positive drug and alcohol screen
- Abdominal surgery within the last 30 days
- Phenylketonuria
- Tobacco or nicotine use within previous 6 months
- Hypersensitivity or contraindication to ondansetron or other 5-HT3 receptor agonists
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OndansetronAlso: ZofranOndansetron solution 4 mg single administration | Drug | Intramuscular Administration |
| Ondansetron + HylenexAlso: ZofranOndansetron solution (4 mg) single administration + Hylenex recombinant (150 U) single administration | Drug | Subcutaneous Administration |
| Zofran ODTAlso: ondansetron disintegrating tablet - oralZofran ODT (8 mg) single administration | Drug | Oral Administration |
| Ondansetron solutionAlso: ZofranOndansetron solution (4 mg) single administration | Drug | Intravenous Administration |
Primary outcome
Evaluation of Overall Safety
Time frame: Days 1-31
Investigator assessment of infusion site observations for parenteral administration; Subject assessment of pain using the verbal response scale for parenteral administration; Subject assessment of pain using the visual analog scale for parenteral administration; Investigator assessment of systemic adverse events
1 secondary outcome
Evaluation of Pharmacokinetics
Time frame: Days 1-5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2014.
- Derived from this study: PubMed 24486335Dychter SS, Harrigan R, Bahn JD, Printz MA, Sugarman BJ, DeNoia E, Haughey DB, Fellows D, Maneval DC. Tolerability and pharmacokinetic properties of ondansetron administered subcutaneously with recombinant human hyaluronidase in minipigs and healthy volunteers. Clin Ther. 2014 Feb 1;36(2):211-24. doi: 10.1016/j.clinthera.2013.12.013. Epub 2014 Jan 31.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samuel S Dychter, MD study director
Halozyme Therapeutics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ondansetron, Ondansetron + Hylenex and Zofran ODT in people with Healthy, run by Halozyme Therapeutics at 1 site in United States.
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 16 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 24 Jan 2014. 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 United States. 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?
Evaluation of Overall Safety (time frame: Days 1-31). 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 NCT01572012, which also lists 1 linked publication.
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 24 Jan 2014.