Opioid OverdosePhase 1NCT01622504
Naloxone Nasal Spray Pharmacokinetic Study
A Phase 1 study testing MVP005 and Naloxone hydrochloride solution for injection with mucosal atomization device in people with Opioid Overdose, run by Mitovie Pharma Ltd at 1 site in Jordan.
Trial summary
This study aims to compare the pharmacokinetics of naloxone when administered as the Mitovie nasal spray (Test Product) and as a solution for injection (Comparator Product) administered intranasally using a mucosal atomization device (MAD). Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Opioid Overdose
- What is being tested?
- MVP005 and Naloxone hydrochloride solution for injection with mucosal atomization device
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteJordan
- Study dates
- Jun 2012to Aug 2012
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female
- 18-60 50 years of age
- Provide written informed consent prior to completing any study specific procedure.
- Body Mass Index (BMI) range 18.5-30 kg/m2
- Clinically acceptable medical history, clinical laboratory evaluations, complete physical examination, vital signs and 12 lead ECG
- Using reliable contraception
Who cannot join
- Intranasal problems
- Taking prescribed or over the counter medications
- Intake of alcohol, methyl-xanthines or grapefruit or strenuous exercise concurrent with treatment.
Trial locations and contacts
1 site in 1 country.
Jordan1 site
International Pharmaceutical Research Center (IPRC)
Amman
Rana Hassan, MSc, +96265627651, r.hassan@iprc.com.jo
Halah Zqqout, BSc, +96265627651, h.zqqout@iprc.com.jo
About this study
Official title: A Phase I Single Dose, Open Label, Randomized, Three Period Crossover Pilot Study to Compare the Pharmacokinetics, Safety and Tolerability of MVP005 Intranasal Spray With Intranasal Administration of Naloxone Solution for Injection in Healthy Adult Subjects
This study aims to compare the pharmacokinetics of naloxone when administered as the Mitovie nasal spray (Test Product) and as a solution for injection (Comparator Product) administered intranasally using a mucosal atomization device (MAD).
Read the detailed description
Naloxone hydrochloride is currently only recommended and licensed for intravenous, intramuscular and subcutaneous administration. It has also been used by intranasal administration (off-label use) when the intravenous route is not suitable by administering the Solution for Injection using a mucosal atomization device (MAD). However, due to the volume of naloxone solution administered this way, some of it may be inadvertently swallowed and not absorbed into the nasal mucosa and the product requires administration by medically trained personnel. The study aims to investigate intranasal administration of naloxone using a more concentrated solution and a nasal delivery device.
- Conditions
- Opioid Overdose
- Being tested
- MVP005, Naloxone hydrochloride solution for injection with mucosal atomization device
- Keywords
- Intranasal, nasal spray, opioid, overdose
- Medical subject headings
- Opiate Overdose, Drug Overdose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MVP005Drug
2 mg single dose administered intranasally
MVP005Drug
4 mg single dose administered intranasally
Naloxone hydrochloride solution for injection with mucosal atomization deviceDrug
2 mg single dose administered intranasally
| Study group | Role | What they receive |
|---|---|---|
| Test Product Dose 1 | Experimental | Not described Receives: Drug: MVP005 |
| Test Product Dose 2 | Experimental | Not described Receives: Drug: MVP005 |
| Comparator Product | Active comparator | Not described Receives: Drug: Naloxone hydrochloride solution for injection with mucosal atomization device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics
Plasma concentration time profiles and area under the curve (AUC), maximum concentation (Cmax), Time to maximum concentration (Tmax), elimination rate constant (Kel) and terminal half life (t1/2)
Measured: 0, 5, 10, 15, 20, 30 and 45 minutes and 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00 and 12.00 hours for each arm
Secondary outcomes (5)
Number of subjects with adverse events
Continuous adverse event monitoring during the study with prompted assessments in the 12 hours post-dose
Measured: 14 days
Physical Examination
Complete physical examination at screening and final follow-up and specific nasal examination post-dose
Measured: 14 days
Vital signs
Vital signs at screening, final follow-up and pre- and post-dose
Measured: 14 days
ECGs
ECGs at screening and final follow-up
Measured: 14 days
Safety Laboratory Tests
Haematology, biochemistry and urinalysis at screening and final follow-up
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionJul 2012 (estimated)
- Study completionAug 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid OverdoseStudies 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
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mitovie Pharma Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Abdullah Hiyari, MD, Principal investigator, IPRC, Jordan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01622504
- Sponsor's protocol ID
- MVP005-CLN-001
- Status last verified
- Jun 2012
- First submitted
- 13 Jun 2012
- Last updated
- 20 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Single Dose, Open Label, Randomized, Three Period Crossover Pilot Study to Compare the Pharmacokinetics, Safety and Tolerability of MVP005 Intranasal Spray With Intranasal Administration of Naloxone Solution for Injection in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT01622504
- Acronym / sponsor ID
- MVP005-CLN-001
- Conditions
- Opioid Overdose
- Keywords
- Intranasal, nasal spray, opioid, overdose
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Mitovie Pharma LtdIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Jul 2012 (estimated)
- Study completion
- Aug 2012 (estimated)
- First posted
- 19 Jun 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 study aims to compare the pharmacokinetics of naloxone when administered as the Mitovie nasal spray (Test Product) and as a solution for injection (Comparator Product) administered intranasally using a mucosal atomization device (MAD).
Detailed description
Naloxone hydrochloride is currently only recommended and licensed for intravenous, intramuscular and subcutaneous administration. It has also been used by intranasal administration (off-label use) when the intravenous route is not suitable by administering the Solution for Injection using a mucosal atomization device (MAD). However, due to the volume of naloxone solution administered this way, some of it may be inadvertently swallowed and not absorbed into the nasal mucosa and the product requires administration by medically trained personnel. The study aims to investigate intranasal administration of naloxone using a more concentrated solution and a nasal delivery device.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Test Product Dose 1 | Experimental | Drug: MVP005 |
| Test Product Dose 2 | Experimental | Drug: MVP005 |
| Comparator Product | Active comparator | Drug: Naloxone hydrochloride solution for injection with mucosal atomization device |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male or female
- 18-60 50 years of age
- Provide written informed consent prior to completing any study specific procedure.
- Body Mass Index (BMI) range 18.5-30 kg/m2
- Clinically acceptable medical history, clinical laboratory evaluations, complete physical examination, vital signs and 12 lead ECG
Key exclusion criteria (3 listed)
- Intranasal problems
- Taking prescribed or over the counter medications
- Intake of alcohol, methyl-xanthines or grapefruit or strenuous exercise concurrent with treatment.
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 |
|---|---|---|
| MVP0052 mg single dose administered intranasally | Drug | Test Product Dose 1 |
| MVP0054 mg single dose administered intranasally | Drug | Test Product Dose 2 |
| Naloxone hydrochloride solution for injection with mucosal atomization device2 mg single dose administered intranasally | Drug | Comparator Product |
Primary outcome
Pharmacokinetics
Time frame: 0, 5, 10, 15, 20, 30 and 45 minutes and 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00 and 12.00 hours for each arm
Plasma concentration time profiles and area under the curve (AUC), maximum concentation (Cmax), Time to maximum concentration (Tmax), elimination rate constant (Kel) and terminal half life (t1/2)
5 secondary outcomes
Number of subjects with adverse events
Time frame: 14 days
Physical Examination
Time frame: 14 days
Vital signs
Time frame: 14 days
ECGs
Time frame: 14 days
Safety Laboratory Tests
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2012.
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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.
Abdullah Hiyari, MD principal investigator
IPRC, Jordan
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 MVP005 and Naloxone hydrochloride solution for injection with mucosal atomization device in people with Opioid Overdose, run by Mitovie Pharma Ltd at 1 site in Jordan.
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 6 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 20 Jun 2012. 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 Jordan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rana Hassan, MSc (+96265627651, r.hassan@iprc.com.jo), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics (time frame: 0, 5, 10, 15, 20, 30 and 45 minutes and 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00 and 12.00 hours for each arm). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jun 2012.