Effect of Ketoconazole on Sufentanil NanoTab Pharmacokinetics

NCT01721070 | Completed Phase 1 Results

• 1 other identifier: IAP104
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pharmacokinetics

Keywords

Area under curve, time to maximum concentration

Outcome Measures

Primary Outcomes (2)

• 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

• 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.

Study Arms (2)

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.

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.

Drug: Ketoconazole 400 mg, sufentanil NanoTab (SUF NT) 15 mcg

Interventions

Sufentanil NanoTab (SUF NT) 15 mcg DRUG

Period 1: One dose of SUF NT 15 mcg administered sublingually

Also known as: SUF NT 15 mcg

SUF NT 15 mcg

Ketoconazole 400 mg, sufentanil NanoTab (SUF NT) 15 mcg DRUG

Period 2: Ketoconazole 400 mg administered daily for three days, SUF NT 15 mcg co-administered sublingually on the third day

Also known as: SUF NT 15 mcg

Ketoconazole 400 mg, SUF NT 15 mcg

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Talphera, Inc: lead

Study Sites (1)

PRA

Lenexa, Kansas, 66219, United States

Location

MeSH Terms

Interventions

Ketoconazole

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Pamela Palmer, MD, PhD
• Organization: AcelRx Pharmaceuticals, Inc.

ppalmer@acelrx.com

650-216-3504

Study Officials

• Pamela P. Palmer, MD, PhD

  Talphera, Inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2012
• First Posted: November 5, 2012
• Study Start: November 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: November 4, 2016
• Results First Posted: March 26, 2014

Record last verified: 2016-09

Locations

US (1)