Effect of Ketoconazole on Sufentanil NanoTab Pharmacokinetics

Talphera

Status and phase: Completed; Phase 1

Conditions: Pharmacokinetics

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01721070

IAP104

Details and patient eligibility

About

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

Enrollment: 19 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

19 participants in 2 patient groups

SUF NT 15 mcg

Experimental group

Description:

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.

Treatment:

Drug: Sufentanil NanoTab (SUF NT) 15 mcg

Ketoconazole 400 mg, SUF NT 15 mcg

Experimental group

Description:

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.

Treatment:

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