MigrainePhase 1NCT01507610
Bioavailability Study to Compare OPTINOSE SUMATRIPTAN With IMITREX® in Healthy Subjects
A Phase 1 study testing Sumatriptan in people with Migraine, run by Optinose US Inc. at 1 site in United States.
Trial summary
The purpose of this study is: To compare the single-dose pharmacokinetics (PK) of intranasal administration of 20 mg OPTINOSE SUMATRIPTAN with 20 mg IMITREX® (sumatriptan) Nasal Spray, 100 mg IMITREX® (sumatriptan) Oral Tablet, and 6 mg IMITREX® (sumatriptan) Subcutaneous Injection, in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Migraine
- What is being tested?
- Sumatriptan
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Feb 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men or women ages 18 to 55 years, inclusive, at screening.
- Healthy with no clinically relevant abnormalities in the opinion of the Investigator as determined by medical history, physical examination, blood chemistry, hematology, including complete blood count, urinalysis, vital signs, and ECG.
- Have a BMI of 18-32 kg/m2, inclusive, and a body weight of not less than 50 kg.
- For females of childbearing potential: either be sexually inactive (abstinent) for 14 days prior to the first dose and throughout the study or be using one of the following acceptable birth control methods:
- intrauterine device in place for at least 3 months prior to the first dose and throughout the study.
- barrier methods (condom, diaphragm) with spermicide for at least 14 days prior to the first dose and throughout the study.
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- surgical sterilization of the partner (vasectomy for 6 months minimum).
- hormonal contraceptives for at least 3 months prior to the first dose of the study and throughout the study.
- Female subjects who claim to be sexually inactive, but become sexually active during the course of the study must agree to use a barrier method (e.g. condom, diaphragm) with spermicide from the time of the start of sexual activity through completion of the study.
- In addition, female subjects of childbearing potential will be advised to remain sexually inactive or to keep the same birth control method for the whole duration of the study.
- Females of non-childbearing potential must have undergone one of the following sterilization procedures at least 6 months prior to Day 1:
- bilateral tubal ligation
- hysterectomy
- bilateral oophorectomy or be postmenopausal with amenorrhea for at least 1 year prior to Day 1 and follicle stimulating hormone (FSH) serum levels ≥ 40 mIU/mL.
- Women of child-bearing potential must have a negative serum beta-human chorionic gonadotropin at the screening visit and at each check-in prior to dosing.
- Agree to abstain from alcohol intake 48 hours before each administration of study agent and during inpatient portion of the study.
- Agree to limit caffeine/methylxanthine (eg, coffee, tea, chocolate, or caffeine-containing soft drinks) intake to less than 300 mg/day for 7 days prior to and for the duration of the study (300 mg of caffeine is equal to approximately 3 cups of coffee or 6 cola drinks), with no intake from 24 hours before dosing and throughout confinement.
- Agree not to consume food or beverages containing, grapefruit or grapefruit juice, Seville oranges, or quinine (e.g. tonic water) 72 hours prior to study Day -1 until after the last PK sample is collected.
- Agree not to consume food containing poppy seeds during the study.
- Have verified airflow through both nostrils and an ability to close the soft palate.
- Must be able to use the OptiNose device correctly.
- Subjects must understand English and have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
- Be willing to adhere to the study visit schedule and other protocol requirements.
Who cannot join
- Currently have or have a history of disease or dysfunction of the pulmonary, cardiovascular, endocrine, hematologic, neurological, immune, gastrointestinal, genitourinary, or other body system that is clinically significant in the opinion of the Investigator.
- Have evidence of any chronic medical conditions requiring prescription medications (eg, hypertension or diabetes).
- Have a history of migraines.
- History of hypersensitivity or allergies to any drug compound, including sumatriptan, any of its components or sulphonamides.
- Have had a major or traumatic surgery within 12 weeks prior to screening, pre-planned surgery or procedures that would interfere with the conduct of the study.
- Have an acute illness within 7 days prior to study agent administration or have had a major illness or hospitalization within 1 month prior to study agent administration.
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- Have clinically significant findings on screening ECG.
- Have a recent history (within 1 previous year) of alcohol or drug abuse.
- History of smoking or use of nicotine-containing substances within the previous 2 months.
- Have abnormal values for hematology, clinical chemistry, or urinalysis at screening or check-in considered clinically significant by the Investigator.
- Have a positive serology test for HIV antibodies, HBsAg, or hepatitis C virus antibody (anti-HCV) at screening.
- Have a positive urine drug screen for ethanol or substances of abuse including cocaine, cannabinoids, phencyclidine, amphetamines, benzodiazepines, barbiturates, opiates, propoxyphene, and methadone at screening and each check-in.
- Have a haemoglobin level below the lower limit of normal at screening.
- Have donated blood or experienced significant blood loss (volume > 500 mL) within 3 months prior to screening, or is planning to donate within 2 months after completion of the study.
- Use of drug metabolizing enzyme (CYP-450) inducers within 28 days prior to dosing or inhibitors within 14 days prior to dosing (refer to Appendix 1).
- Use of any monoamine oxidase inhibitors (MAOI) within 28 days prior to dosing.
- Use of any prescription medications/products, except hormonal contraceptives, within 14 days prior to study entry.
- Use of any OTC, nonprescription preparation (including minerals and phytotherapeutic/herbal/plant-derived preparations), within 14 days prior to study entry, with the exception of ibuprofen, and acetaminophen used at recommended doses. For acetaminophen, a maximum of 1500 mg per day and no more than 3 g per week, will be allowed for the treatment of headache or other pain.
- Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 4 weeks prior to dosing, or plan to participate in an investigational drug study less than 1 month after completion of the study.
- A recent febrile illness within 3 days of the start of the study drug intake on Day 1.
- If a woman, must not be breast-feeding or planning to become pregnant during the study.
- Must refrain from physical activity (jogging, strenuous exercise of all types), and sunbathing while confined to the study center and 48 hours before admission to the study center.
- Reports or exhibits abnormalities regarding the sense of smell and/or taste.
- Reports a temporary loss of or abnormality of sense of smell and/or taste due to recent (within the 2 weeks prior to Day 1) cold or viral infections.
- Presence of respiratory diseases or known nasal obstruction including allergic rhinitis, nasal septum deviation, polyposis, severe mucosal swelling, nasal ulcers, nasal trauma,or any other reason.
- Have a history of chronic nose bleeds.
- Current nasopharyngeal illness.
- Known velum insufficiency, ie, those with cleft palate and/or structural abnormalities in the soft palate and nasopharynx.
- Any condition that in the opinion of the Investigator would complicate or compromise the study, or the well-being of the subject.
- Is an employee of the Investigator/study center or the Sponsor.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, Single-Dose, Randomized, Crossover Study to Compare the Bioavailability of the Intranasal Administration of 20 mg OPTINOSE SUMATRIPTAN With 20 mg IMITREX® (Sumatriptan) Nasal Spray, 100 mg IMITREX® (Sumatriptan) Oral Tablet and 6 mg IMITREX® (Sumatriptan) Subcutaneous Injection in Healthy Subjects
The purpose of this study is:
- To compare the single-dose pharmacokinetics (PK) of intranasal administration of 20 mg OPTINOSE SUMATRIPTAN with 20 mg IMITREX® (sumatriptan) Nasal Spray, 100 mg IMITREX® (sumatriptan) Oral Tablet, and 6 mg IMITREX® (sumatriptan) Subcutaneous Injection, in healthy subjects.
- To estimate the relative bioavailability of single-dose intranasal administration of 20 mg OPTINOSE SUMATRIPTAN, 20 mg IMITREX® (sumatriptan) Nasal Spray, and 100 mg IMITREX® (sumatriptan) Oral Tablet compared to a single-dose of 6 mg IMITREX® (sumatriptan) Subcutaneous Injection, in healthy subjects.
- Conditions
- Migraine
- Being tested
- Sumatriptan
- Keywords
- sumatriptan, bioavailability
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SumatriptanDrug
To compare the single-dose pharmacokinetics (PK) and relative bioavailability of intranasal administration of 20 mg OPTINOSE SUMATRIPTAN with 20 mg IMITREX® (sumatriptan) Nasal Spray, 100 mg IMITREX® (sumatriptan) Oral Tablet, and 6 mg IMITREX® (sumatriptan) Subcutaneous Injection, in healthy subjects.
| Study group | Role | What they receive |
|---|---|---|
| Investigational | Experimental | OPTINOSE SUMATRIPTAN, single dose of 20 mg intranasally (10 mg to each nostril). Receives: Drug: Sumatriptan |
| IMITREX Nasal Spray | Active comparator | IMITREX® (sumatriptan) Nasal Spray, single dose of 20 mg intranasally (20 mg to one nostril). Receives: Drug: Sumatriptan |
| IMITREX Oral Tablet | Active comparator | IMITREX® (sumatriptan) Oral Tablet, single dose of 100 mg, administered orally with 240 mL water. Receives: Drug: Sumatriptan |
| IMITREX Subcutaneous Injection | Active comparator | IMITREX® (sumatriptan) Subcutaneous Injection, single dose of 6 mg injected subcutaneously in the abdomen. Receives: Drug: Sumatriptan |
What is being measured
The primary outcome is the main question the study is designed to answer.
The pharmacokinetic parameters of sumatriptan following the administration of OPTINOSE SUMATRIPTAN and IMITREX® (sumatriptan).
The pharmacokinetic parameters AUC0-∞ and Cmax of sumatriptan following the administration of 20 mg OPTINOSE SUMATRIPTAN, 20 mg IMITREX® (sumatriptan) Nasal Spray, 100 mg IMITREX® (sumatriptan) Oral Tablet, and 6 mg IMITREX® (sumatriptan) Subcutaneous Injection.
- The relative bioavailability (Frel) of sumatriptan following the nasal administration of 20 mg OPTINOSE SUMATRIPTAN, 20 mg IMITREX® (sumatriptan) Nasal Spray, and 100 mg IMITREX® (sumatriptan) Oral Tablet compared to 6 mg IMITREX® (sumatriptan) Subcutaneous Injection.
Measured: Measurement of pharmacokinetic parameters of sumatriptan at pre-treatment and at: 2, 5, 10, 15, 20, 25, 30, 45 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 14 hours post treatments.
Bioavailability of sumatriptan following the administration of OPTINOSE SUMATRIPTAN and IMITREX® (sumatriptan).
The relative bioavailability (Frel) of sumatriptan following the nasal administration of 20 mg OPTINOSE SUMATRIPTAN, 20 mg IMITREX® (sumatriptan) Nasal Spray, and 100 mg IMITREX® (sumatriptan) Oral Tablet compared to 6 mg IMITREX® (sumatriptan) Subcutaneous Injection.
Measured: Measurement of plasma sumatriptan concentrations at pre-treatment and at: 2, 5, 10, 15, 20, 25, 30, 45 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 14 hours post treatments.
Secondary outcomes (2)
Sensory attributes of the intranasal OPTINOSE SUMATRIPTAN product and IMITREX® (sumatriptan).
Sensory attributes of the intranasal OPTINOSE SUMATRIPTAN product, IMITREX® (sumatriptan) Nasal Spray and 100 mg IMITREX® (sumatriptan) Oral Tablet will be evaluated using a 14-item or 4 item Sensory Nasal Spray Evaluation Questionnaire.
Measured: Sensory attributes will be evaluated within 2 minutes after drug administration. The evaluation will be repeated within 5 to 10 minutes after drug administration.
Safety Evaluations of the intranasal OPTINOSE SUMATRIPTAN product and IMITREX®
Safety evaluation will be based on physical examinations, vital signs, 12-lead electrocardiograms (ECGs), clinical laboratory tests (hematology, serum chemistry and urinalysis), and adverse events (AEs).
Measured: Safety evaluations will be perfromed on days 1, 8, 15, 22, 25 and 32
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionFeb 2012
- Study completionFeb 2012
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 MigraineStudies 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Optinose US Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01507610
- Sponsor's protocol ID
- OPN-SUM-1302
- Status last verified
- Jan 2012
- First submitted
- 4 Jan 2012
- Last updated
- 29 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Obaidi M, Offman E, Messina J, Carothers J, Djupesland PG, Mahmoud RA. Improved pharmacokinetics of sumatriptan with Breath Powered nasal delivery of sumatriptan powder. Headache. 2013 Sep;53(8):1323-33. doi: 10.1111/head.12167. Epub 2013 Aug 28.
PubMed 23992438
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single-Dose, Randomized, Crossover Study to Compare the Bioavailability of the Intranasal Administration of 20 mg OPTINOSE SUMATRIPTAN With 20 mg IMITREX® (Sumatriptan) Nasal Spray, 100 mg IMITREX® (Sumatriptan) Oral Tablet and 6 mg IMITREX® (Sumatriptan) Subcutaneous Injection in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01507610
- Acronym / sponsor ID
- OPN-SUM-1302
- Conditions
- Migraine
- Keywords
- sumatriptan, bioavailability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Optinose US Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 11 Jan 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.
The purpose of this study is:
- To compare the single-dose pharmacokinetics (PK) of intranasal administration of 20 mg OPTINOSE SUMATRIPTAN with 20 mg IMITREX® (sumatriptan) Nasal Spray, 100 mg IMITREX® (sumatriptan) Oral Tablet, and 6 mg IMITREX® (sumatriptan) Subcutaneous Injection, in healthy subjects.
- To estimate the relative bioavailability of single-dose intranasal administration of 20 mg OPTINOSE SUMATRIPTAN, 20 mg IMITREX® (sumatriptan) Nasal Spray, and 100 mg IMITREX® (sumatriptan) Oral Tablet compared to a single-dose of 6 mg IMITREX® (sumatriptan) Subcutaneous Injection, in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Investigational | Experimental | Drug: SumatriptanOPTINOSE SUMATRIPTAN, single dose of 20 mg intranasally (10 mg to each nostril). |
| IMITREX Nasal Spray | Active comparator | Drug: SumatriptanIMITREX® (sumatriptan) Nasal Spray, single dose of 20 mg intranasally (20 mg to one nostril). |
| IMITREX Oral Tablet | Active comparator | Drug: SumatriptanIMITREX® (sumatriptan) Oral Tablet, single dose of 100 mg, administered orally with 240 mL water. |
| IMITREX Subcutaneous Injection | Active comparator | Drug: SumatriptanIMITREX® (sumatriptan) Subcutaneous Injection, single dose of 6 mg injected subcutaneously in the abdomen. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (23 listed)
- Men or women ages 18 to 55 years, inclusive, at screening.
- Healthy with no clinically relevant abnormalities in the opinion of the Investigator as determined by medical history, physical examination, blood chemistry, hematology, including complete blood count, urinalysis, vital signs, and ECG.
- Have a BMI of 18-32 kg/m2, inclusive, and a body weight of not less than 50 kg.
- For females of childbearing potential: either be sexually inactive (abstinent) for 14 days prior to the first dose and throughout the study or be using one of the following acceptable birth control methods:
- Females of non-childbearing potential must have undergone one of the following sterilization procedures at least 6 months prior to Day 1:
Key exclusion criteria (30 listed)
- Currently have or have a history of disease or dysfunction of the pulmonary, cardiovascular, endocrine, hematologic, neurological, immune, gastrointestinal, genitourinary, or other body system that is clinically significant in the opinion of the Investigator.
- Have evidence of any chronic medical conditions requiring prescription medications (eg, hypertension or diabetes).
- Have a history of migraines.
- History of hypersensitivity or allergies to any drug compound, including sumatriptan, any of its components or sulphonamides.
- Have had a major or traumatic surgery within 12 weeks prior to screening, pre-planned surgery or procedures that would interfere with the conduct of the study.
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 |
|---|---|---|
| SumatriptanTo compare the single-dose pharmacokinetics (PK) and relative bioavailability of intranasal administration of 20 mg OPTINOSE SUMATRIPTAN with 20 mg IMITREX® (sumatriptan) Nasal Spray, 100 mg IMITREX® (sumatriptan) Oral Tablet, and 6 mg IMITREX® (sumatriptan) Subcutaneous Injection, in healthy subjects. | Drug | IMITREX Nasal Spray, IMITREX Oral Tablet, IMITREX Subcutaneous Injection, Investigational |
Primary outcome
The pharmacokinetic parameters of sumatriptan following the administration of OPTINOSE SUMATRIPTAN and IMITREX® (sumatriptan).
Time frame: Measurement of pharmacokinetic parameters of sumatriptan at pre-treatment and at: 2, 5, 10, 15, 20, 25, 30, 45 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 14 hours post treatments.
The pharmacokinetic parameters AUC0-∞ and Cmax of sumatriptan following the administration of 20 mg OPTINOSE SUMATRIPTAN, 20 mg IMITREX® (sumatriptan) Nasal Spray, 100 mg IMITREX® (sumatriptan) Oral Tablet, and 6 mg IMITREX® (sumatriptan) Subcutaneous Injection. • The relative bioavailability (Frel) of sumatriptan following the nasal administration of 20 mg OPTINOSE SUMATRIPTAN, 20 mg IMITREX® (sumatriptan) Nasal Spray, and 100 mg IMITREX® (sumatriptan) Oral Tablet compared to 6 mg IMITREX® (sumatriptan) Subcutaneous Injection.
Bioavailability of sumatriptan following the administration of OPTINOSE SUMATRIPTAN and IMITREX® (sumatriptan).
Time frame: Measurement of plasma sumatriptan concentrations at pre-treatment and at: 2, 5, 10, 15, 20, 25, 30, 45 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 14 hours post treatments.
The relative bioavailability (Frel) of sumatriptan following the nasal administration of 20 mg OPTINOSE SUMATRIPTAN, 20 mg IMITREX® (sumatriptan) Nasal Spray, and 100 mg IMITREX® (sumatriptan) Oral Tablet compared to 6 mg IMITREX® (sumatriptan) Subcutaneous Injection.
2 secondary outcomes
Sensory attributes of the intranasal OPTINOSE SUMATRIPTAN product and IMITREX® (sumatriptan).
Time frame: Sensory attributes will be evaluated within 2 minutes after drug administration. The evaluation will be repeated within 5 to 10 minutes after drug administration.
Safety Evaluations of the intranasal OPTINOSE SUMATRIPTAN product and IMITREX®
Time frame: Safety evaluations will be perfromed on days 1, 8, 15, 22, 25 and 32
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 29 Feb 2012.
- Derived from this study: PubMed 23992438Obaidi M, Offman E, Messina J, Carothers J, Djupesland PG, Mahmoud RA. Improved pharmacokinetics of sumatriptan with Breath Powered nasal delivery of sumatriptan powder. Headache. 2013 Sep;53(8):1323-33. doi: 10.1111/head.12167. Epub 2013 Aug 28.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Sumatriptan in people with Migraine, run by Optinose US Inc. 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 23 inclusion and 30 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 29 Feb 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 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?
The pharmacokinetic parameters of sumatriptan following the administration of OPTINOSE SUMATRIPTAN and IMITREX® (sumatriptan). (time frame: Measurement of pharmacokinetic parameters of sumatriptan at pre-treatment and at: 2, 5, 10, 15, 20, 25, 30, 45 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 14 hours post treatments.). The study lists 2 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 NCT01507610, 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 29 Feb 2012.