Effect of Ketoconazole on Sufentanil NanoTab Pharmacokinetics

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AcelRx Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01721070
First received: November 1, 2012
Last updated: February 11, 2014
Last verified: February 2014
  Purpose

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


Condition Intervention Phase
Pharmacokinetics
Drug: Sufentanil NanoTab (SUF NT) 15 mcg
Drug: Ketoconazole 400 mg, sufentanil NanoTab (SUF NT) 15 mcg
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: IAP104 - Assessment of Pharmacokinetic Changes Following Concurrent Administration of Sufentanil NanoTab and Ketoconazole in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by AcelRx Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • AUC (0-inf) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    total amount of sufentanil absorbed

  • Cmax [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    maximum plasma concentration


Enrollment: 19
Study Start Date: November 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: Sufentanil NanoTab (SUF NT) 15 mcg
Period 1: One dose of SUF NT 15 mcg administered sublingually
Other Name: SUF NT 15 mcg
Experimental: Ketoconazole 400 mg, 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.

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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01721070

Locations
United States, Kansas
PRA
Lenexa, Kansas, United States, 66219
Sponsors and Collaborators
AcelRx Pharmaceuticals, Inc.
Investigators
Study Director: Pamela P. Palmer, MD, PhD AcelRx Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: AcelRx Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01721070     History of Changes
Other Study ID Numbers: IAP104
Study First Received: November 1, 2012
Results First Received: February 10, 2014
Last Updated: February 11, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by AcelRx Pharmaceuticals, Inc.:
Area under curve, time to maximum concentration

Additional relevant MeSH terms:
Ketoconazole
Sufentanil
14-alpha Demethylase Inhibitors
Adjuvants, Anesthesia
Analgesics
Analgesics, Opioid
Anesthetics
Anesthetics, General
Anesthetics, Intravenous
Anti-Infective Agents
Antifungal Agents
Central Nervous System Agents
Central Nervous System Depressants
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014