HealthyPhase 1NCT02082236
Pharmacokinetics of Sufentanil Sublingual Microtablet 30 mcg and 15 mcg in Healthy Subjects
A Phase 1 study testing Treatment Arm A: Sufenta®, Treatment B: Sufentanil SSM 30 mcg and Treatment C: SSM 15 mcg in people with Healthy, run by Talphera, Inc at 1 site in United States.
Trial summary
The purpose of this study is to establish the single and multiple-dose pharmacokinetics (PK) of sublingual administration of the Sufentanil Sublingual Microtablet (SSM) 30 mcg and compare the pharmacokinetics of a single dose of SSM 30 mcg to 2 doses of SSM 15 mcg administered 20 minutes apart. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Treatment Arm A: Sufenta®, Treatment B: Sufentanil SSM 30 mcg and Treatment C: SSM 15 mcg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to May 2014
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Non-smoking male or female subjects
- Aged between 18 and 45 years inclusive
- Subjects must have Body Mass Index (BMI) between 18 and 30, inclusively.
Who cannot join
- Subjects who are taking over-the-counter medication (except for single dose multi-vitamin supplements or acetaminophen of less than 2 g/day) within 14 days prior to start of sufentanil dosing prescription medications or over the counter (OTC) medications
- Female subjects who are pregnant
- Subjects with chronic obstructive pulmonary disease, sleep apnea, or other significant respiratory disorders
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to establish the single and multiple-dose pharmacokinetics (PK) of sublingual administration of the Sufentanil Sublingual Microtablet (SSM) 30 mcg and compare the pharmacokinetics of a single dose of SSM 30 mcg to 2 doses of SSM 15 mcg administered 20 minutes apart.
- Conditions
- Healthy
- Being tested
- Treatment Arm A: Sufenta®, Treatment B: Sufentanil SSM 30 mcg, Treatment C: SSM 15 mcg, Treatment D: SSM 30 mcg
- Keywords
- Plasma concentrations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment Arm A: Sufenta®Drug
Sufenta® intravenous (IV) (50 mcg/mL) 30 mcg infused over 1 minute
Treatment B: Sufentanil SSM 30 mcgDrug
single-dose SSM 30 mcg
Treatment C: SSM 15 mcgDrug
2 consecutive doses of SSM 15 mcg administered 20 minutes apart
Treatment D: SSM 30 mcgDrug
12 consecutive doses of SSM 30 mcg administered 1 hour apart
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Active comparator | Sufenta® IV (50 mcg/mL) 30 mcg infused over 1 minute Receives: Drug: Treatment Arm A: Sufenta® |
| Treatment B | Experimental | Single dose of SSM 30 mcg Receives: Drug: Treatment B: Sufentanil SSM 30 mcg |
| Treatment C | Experimental | 2 consecutive doses of SSM 15 mcg administered 20 minute apart Receives: Drug: Treatment C: SSM 15 mcg |
| Treatment D | Experimental | 12 consecutive doses of SSM 30 mcg administered 1 hour apart Receives: Drug: Treatment D: SSM 30 mcg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Curve
Area under the plasma concentration time curve
Measured: 9 days, not including a 30 day screening window
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2014 (estimated)
- Study startMay 2014
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Talphera, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sandra K. Willsie, D.O., Principal investigator, PRA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02082236
- Sponsor's protocol ID
- SAP101
- Status last verified
- Jul 2018
- First submitted
- 6 Mar 2014
- Last updated
- 17 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Sufentanil Sublingual Microtablet 30 mcg and 15 mcg in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02082236
- Acronym / sponsor ID
- SAP101
- Conditions
- Healthy
- Keywords
- Plasma concentrations
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Talphera, IncIndustry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 10 Mar 2014 (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 establish the single and multiple-dose pharmacokinetics (PK) of sublingual administration of the Sufentanil Sublingual Microtablet (SSM) 30 mcg and compare the pharmacokinetics of a single dose of SSM 30 mcg to 2 doses of SSM 15 mcg administered 20 minutes apart.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Active comparator | Drug: Treatment Arm A: Sufenta®Sufenta® IV (50 mcg/mL) 30 mcg infused over 1 minute |
| Treatment B | Experimental | Drug: Treatment B: Sufentanil SSM 30 mcgSingle dose of SSM 30 mcg |
| Treatment C | Experimental | Drug: Treatment C: SSM 15 mcg2 consecutive doses of SSM 15 mcg administered 20 minute apart |
| Treatment D | Experimental | Drug: Treatment D: SSM 30 mcg12 consecutive doses of SSM 30 mcg administered 1 hour apart |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Non-smoking male or female subjects
- Aged between 18 and 45 years inclusive
- Subjects must have Body Mass Index (BMI) between 18 and 30, inclusively.
Key exclusion criteria (3 listed)
- Subjects who are taking over-the-counter medication (except for single dose multi-vitamin supplements or acetaminophen of less than 2 g/day) within 14 days prior to start of sufentanil dosing prescription medications or over the counter (OTC) medications
- Female subjects who are pregnant
- Subjects with chronic obstructive pulmonary disease, sleep apnea, or other significant respiratory disorders
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 |
|---|---|---|
| Treatment Arm A: Sufenta®Sufenta® intravenous (IV) (50 mcg/mL) 30 mcg infused over 1 minute | Drug | Treatment A |
| Treatment B: Sufentanil SSM 30 mcgsingle-dose SSM 30 mcg | Drug | Treatment B |
| Treatment C: SSM 15 mcg2 consecutive doses of SSM 15 mcg administered 20 minutes apart | Drug | Treatment C |
| Treatment D: SSM 30 mcg12 consecutive doses of SSM 30 mcg administered 1 hour apart | Drug | Treatment D |
Primary outcome
Area Under the Curve
Time frame: 9 days, not including a 30 day screening window
Area under the plasma concentration time curve
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 17 Jul 2018.
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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.
Sandra K. Willsie, D.O. principal investigator
PRA
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 Treatment Arm A: Sufenta®, Treatment B: Sufentanil SSM 30 mcg and Treatment C: SSM 15 mcg in people with Healthy, run by Talphera, 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 3 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: finished, as of the sponsor's last update on 17 Jul 2018. 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?
Area Under the Curve (time frame: 9 days, not including a 30 day screening window). 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 17 Jul 2018.