Effect of Ketoconazole on Sufentanil NanoTab Pharmacokinetics

Talphera, Inc19 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Pharmacokinetics

Interventions

Sufentanil NanoTab (SUF NT) 15 mcgDRUG

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

Ketoconazole 400 mg, sufentanil NanoTab (SUF NT) 15 mcgDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

PRA

Lenexa, Kansas, United States

Outcomes

Primary Outcomes

AUC (0-inf)

Total amount of sufentanil absorbed; After each dosing of Sufentanil NanoTab, serial blood samples will be taken at regular time points.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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