Effect of Ketoconazole on Sufentanil NanoTab Pharmacokinetics

Phase 1

Completed

• Conditions: Pharmacokinetics
• Interventions: Drug: Sufentanil NanoTab (SUF NT) 15 mcg; Drug: Ketoconazole 400 mg, sufentanil NanoTab (SUF NT) 15 mcg

• Registration Number: NCT01721070
• Lead Sponsor: Talphera, Inc

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2012-11-01
• Study First Submitted QC: 2012-11-01
• Study First Posted: 2012-11-04
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Results First Submitted: 2014-02-10
• Results First Submitted QC: 2014-02-11
• Results First Posted: 2014-03-26
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-30
• Last Update Posted: 2016-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SUF NT 15 mcg	Sufentanil NanoTab (SUF NT) 15 mcg	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.
Ketoconazole 400 mg, SUF NT 15 mcg	Ketoconazole 400 mg, sufentanil NanoTab (SUF NT) 15 mcg	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.

Primary Outcome Measures

Name	Time	Method
AUC (0-inf)	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	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.

Trial Locations

Locations (1)

PRA; 🇺🇸 Lenexa, Kansas, United States