PharmacokineticsPhase 1NCT01721070

Effect of Ketoconazole on Sufentanil NanoTab Pharmacokinetics

A Phase 1 study testing Sufentanil NanoTab (SUF NT) 15 mcg and Ketoconazole 400 mg, sufentanil NanoTab (SUF NT) 15 mcg in people with Pharmacokinetics, run by Talphera, Inc at 1 site in United States.

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

Evaluate the effect of taking ketoconazole on sufentanil plasma concentrations following sublingual administration of sufentanil NanoTab. Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Pharmacokinetics
What is being tested?: Sufentanil NanoTab (SUF NT) 15 mcg and Ketoconazole 400 mg, sufentanil NanoTab (SUF NT) 15 mcg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 19 participants
Where: 1 siteUnited States
Study dates: Nov 2012to Dec 2012
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
Ages 18 to 45 year, inclusive
BMI between 18 and 30

Who cannot join

subjects taking any prescription or OTC medications or vitamins or supplements
pregnant females
subjects with pulmonary disease or sleep apnea

Trial locations and contacts

1 site in 1 country.

United States1 site

PRA
Lenexa, Kansas, 66219

Other trials in United States

About this study

Official title: IAP104 - Assessment of Pharmacokinetic Changes Following Concurrent Administration of Sufentanil NanoTab and Ketoconazole in Healthy Subjects

Evaluate the effect of taking ketoconazole on sufentanil plasma concentrations following sublingual administration of sufentanil NanoTab.

Conditions: Pharmacokinetics
Being tested: Sufentanil NanoTab (SUF NT) 15 mcg, Ketoconazole 400 mg, sufentanil NanoTab (SUF NT) 15 mcg
Keywords: Area under curve, time to maximum concentration

What participants receive

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

Sufentanil NanoTab (SUF NT) 15 mcgDrug
Also called SUF NT 15 mcg
Period 1: One dose of SUF NT 15 mcg administered sublingually
Ketoconazole 400 mg, sufentanil NanoTab (SUF NT) 15 mcgDrug
Also called SUF NT 15 mcg
Period 2: Ketoconazole 400 mg administered daily for three days, SUF NT 15 mcg co-administered sublingually on the third day

Study groups in NCT01721070
Study group	Role	What they receive
SUF NT 15 mcg	Experimental	Period 1: One dose of SUF NT 15 mcg administered sublingually. Subjects also received one dose of oral naltrexone 50 mg in the evening before and the morning of each SUF NT dosing to block the opioid effects of the sufentanil. Receives: Drug: Sufentanil NanoTab (SUF NT) 15 mcg
Ketoconazole 400 mg, SUF NT 15 mcg	Experimental	Ketoconazole 400 mg administered once daily for three days. One dose of SUF NT 15 mcg was co-administered sublingually with the third (last) ketoconazole dose. Subjects also received one dose of oral naltrexone 50 mg in the evening before and the morning of each SUF NT dosing to block the opioid effects of the sufentanil. Receives: Drug: Ketoconazole 400 mg, sufentanil NanoTab (SUF NT) 15 mcg

What is being measured

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

AUC (0-inf)
Total amount of sufentanil absorbed; After each dosing of Sufentanil NanoTab, serial blood samples will be taken at regular time points.
Measured: 0 (pre-dose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 120, 180, 240, 360, 480, 600, 720, and 840 minutes, and 24 hours after dosing.24 hours
Cmax
Maximum plasma concentration; After each dosing of Sufentanil NanoTab, serial blood samples will be taken at regular time points.
Measured: 0 (pre-dose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 120, 180, 240, 360, 480, 600, 720, and 840 minutes, and 24 hours after dosing.

Timeline

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

Nov 2012Dec 2012

First posted5 Nov 2012 (estimated)
Study startNov 2012
Primary completionDec 2012
Study completionDec 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for PharmacokineticsStudies 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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 19 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01721070
Sponsor's protocol ID: IAP104
Status last verified: Sep 2016
First submitted: 1 Nov 2012
Last updated: 4 Nov 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Pharmacokinetics trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: IAP104 - Assessment of Pharmacokinetic Changes Following Concurrent Administration of Sufentanil NanoTab and Ketoconazole in Healthy Subjects
ClinicalTrials.gov ID: NCT01721070
Acronym / sponsor ID: IAP104
Conditions: Pharmacokinetics
Keywords: Area under curve, time to maximum concentration
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 19 participants (actual)
Lead sponsor: Talphera, IncIndustry (pharma, biotech, devices)
Study start: Nov 2012
Primary completion: Dec 2012 (actual)
Study completion: Dec 2012 (actual)
First posted: 5 Nov 2012 (estimated)
Results: Posted 26 Mar 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Evaluate the effect of taking ketoconazole on sufentanil plasma concentrations following sublingual administration of sufentanil NanoTab.

Study design

Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
SUF NT 15 mcg	Experimental	Drug: Sufentanil NanoTab (SUF NT) 15 mcgPeriod 1: One dose of SUF NT 15 mcg administered sublingually. Subjects also received one dose of oral naltrexone 50 mg in the evening before and the morning of each SUF NT dosing to block the opioid effects of the sufentanil.
Ketoconazole 400 mg, SUF NT 15 mcg	Experimental	Drug: Ketoconazole 400 mg, sufentanil NanoTab (SUF NT) 15 mcgKetoconazole 400 mg administered once daily for three days. One dose of SUF NT 15 mcg was co-administered sublingually with the third (last) ketoconazole dose. Subjects also received one dose of oral naltrexone 50 mg in the evening before and the morning of each SUF NT dosing to block the opioid effects of the sufentanil.

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Non smoking
Ages 18 to 45 year, inclusive
BMI between 18 and 30

Key exclusion criteria (3 listed)

subjects taking any prescription or OTC medications or vitamins or supplements
pregnant females
subjects with pulmonary disease or sleep apnea

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
Sufentanil NanoTab (SUF NT) 15 mcgAlso: SUF NT 15 mcgPeriod 1: One dose of SUF NT 15 mcg administered sublingually	Drug	SUF NT 15 mcg
Ketoconazole 400 mg, sufentanil NanoTab (SUF NT) 15 mcgAlso: SUF NT 15 mcgPeriod 2: Ketoconazole 400 mg administered daily for three days, SUF NT 15 mcg co-administered sublingually on the third day	Drug	Ketoconazole 400 mg, SUF NT 15 mcg

Primary outcome

AUC (0-inf)
Time frame: 0 (pre-dose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 120, 180, 240, 360, 480, 600, 720, and 840 minutes, and 24 hours after dosing.24 hours
Total amount of sufentanil absorbed; After each dosing of Sufentanil NanoTab, serial blood samples will be taken at regular time points.
Cmax
Time frame: 0 (pre-dose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 120, 180, 240, 360, 480, 600, 720, and 840 minutes, and 24 hours after dosing.
Maximum plasma concentration; After each dosing of Sufentanil NanoTab, serial blood samples will be taken at regular time points.

Results and safety

Results posted to the registry on 26 Mar 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
SUF NT 15 mcg Followed by Ketoconazole 400 mg + SUF NT 15 mcg	19	19

Primary outcome: AUC (0-inf)

Time frame: 0 (pre-dose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 120, 180, 240, 360, 480, 600, 720, and 840 minutes, and 24 hours after dosing.24 hours. Geometric mean (Geometric Coefficient of Variation). Unit: h*pg/mL

Measure	SUF NT 15 mcg n = 17	Ketoconazole 400 mg and SUF NT 15 mcg n = 17
Value	126.47 (46.42)	223.63 (45.45)

Population analysed: 2 of the 19 subjects had incomplete PK data and were excluded from PK analysis (1 due to early withdrawal and 1 due to AE)

Primary outcome: Cmax

Time frame: 0 (pre-dose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 120, 180, 240, 360, 480, 600, 720, and 840 minutes, and 24 hours after dosing.. Mean (Standard Deviation). Unit: pg/mL

Measure	SUF NT 15 mcg n = 17	Ketoconazole 400 mg and SUF NT 15 mcg n = 17
Value	39.95 (18.57)	46.00 (16.50)

Population analysed: 2 of the 19 subjects had incomplete PK data and were excluded from PK analysis (1 due to early withdrawal and 1 due to AE)

Adverse events

Time frame: Four days. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SUF NT 15 mcg	0 of 19 (0%)	5 of 19 (26.3%)	Not reported
Ketoconazole 400 mg + SUF NT 15 mcg	0 of 18 (0%)	4 of 18 (22.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Pharmacokinetics

RecruitingObservational study
Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
Pyelonephritis
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingPhase 2
A UGT1A1 Genotype-Directed Study of Belinostat Pharmacokinetics and Toxicity
Carcinoma, Neuroendocrine, Tumor, Neuroendocrine
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease

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.

Pamela P. Palmer, MD, PhD study director

Talphera, Inc

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 Nov 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 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?

Yes. Results are posted in the registry (first posted 26 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

AUC (0-inf) (time frame: 0 (pre-dose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 120, 180, 240, 360, 480, 600, 720, and 840 minutes, and 24 hours after dosing.24 hours). 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 NCT01721070.

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 4 Nov 2016.