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NCT01721070 Clinical Trial

Effect of Ketoconazole on Sufentanil NanoTab Pharmacokinetics

Pharmacokinetics Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01721070
Other study ID # IAP104
Secondary ID
Status Completed
Phase Phase 1
First received November 1, 2012
Last updated February 11, 2014
Start date November 2012
Est. completion date December 2012

Study information
Verified date February 2014
Source AcelRx Pharmaceuticals, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 19
Est. completion date December 2012
Est. primary completion date December 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 45 Years
Eligibility 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

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

Intervention

Drug:
• Sufentanil NanoTab (SUF NT) 15 mcg
Period 1: One dose of SUF NT 15 mcg administered sublingually
• 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

Locations
Country Name City State
United States PRA Lenexa Kansas

Sponsors (1)
Lead Sponsor Collaborator
AcelRx Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary AUC (0-inf) total amount of sufentanil absorbed 24 hours No
Primary Cmax maximum plasma concentration 24 hours No
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