Effect of Ketoconazole on Sufentanil NanoTab Pharmacokinetics

Study Overview
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Brief Summary
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Evaluate the effect of taking ketoconazole on sufentanil plasma concentrations following sublingual administration of sufentanil NanoTab.

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

Conditions
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Pharmacokinetics

Intervention / Treatment
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* Drug: Sufentanil NanoTab (SUF NT) 15 mcg
* Drug: Ketoconazole 400 mg, sufentanil NanoTab (SUF NT) 15 mcg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Non smoking Ages 18 to 45 year, inclusive BMI between 18 and 30 Exclusion Criteria: subjects taking any prescription or OTC medications or vitamins or supplements pregnant females subjects with pulmonary disease or sleep apnea

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SUF NT 15 mcg<br>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. | Drug: Sufentanil NanoTab (SUF NT) 15 mcg<br>* Period 1: One dose of SUF NT 15 mcg administered sublingually<br>* Other names: SUF NT 15 mcg;|
| Experimental: Ketoconazole 400 mg, SUF NT 15 mcg<br>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. | Drug: Ketoconazole 400 mg, sufentanil NanoTab (SUF NT) 15 mcg<br>* Period 2: Ketoconazole 400 mg administered daily for three days, SUF NT 15 mcg co-administered sublingually on the third day<br>* Other names: SUF NT 15 mcg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax | Maximum plasma concentration; After each dosing of Sufentanil NanoTab, serial blood samples will be taken at regular time points. | 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. | 
| AUC (0-inf) | Total amount of sufentanil absorbed; After each dosing of Sufentanil NanoTab, serial blood samples will be taken at regular time points. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Area under curve, time to maximum concentration