Pharmacokinetics of Sufentanil Sublingual Microtablet 30 mcg and 15 mcg in Healthy Subjects

The purpose of this study is to establish the single and multiple-dose pharmacokinetics (PK) of sublingual administration of the Sufentanil Sublingual Microtablet (SSM) 30 mcg and compare the pharmacokinetics of a single dose of SSM 30 mcg to 2 doses of SSM 15 mcg administered 20 minutes apart.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Treatment Arm A: Sufenta®; Drug: Treatment B: Sufentanil SSM 30 mcg; Drug: Treatment C: SSM 15 mcg; Drug: Treatment D: SSM 30 mcg

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Lenexa, Kansas, United States, 66219
      • PRA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Non-smoking male or female subjects
2. Aged between 18 and 45 years inclusive
3. Subjects must have Body Mass Index (BMI) between 18 and 30, inclusively.

Exclusion Criteria:

1. Subjects who are taking over-the-counter medication (except for single dose multi-vitamin supplements or acetaminophen of less than 2 g/day) within 14 days prior to start of sufentanil dosing prescription medications or over the counter (OTC) medications
2. Female subjects who are pregnant
3. Subjects with chronic obstructive pulmonary disease, sleep apnea, or other significant respiratory disorders

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Treatment A; Sufenta® IV (50 mcg/mL) 30 mcg infused over 1 minute	Drug: Treatment Arm A: Sufenta®; Sufenta® intravenous (IV) (50 mcg/mL) 30 mcg infused over 1 minute
EXPERIMENTAL: Treatment B; Single dose of SSM 30 mcg	Drug: Treatment B: Sufentanil SSM 30 mcg; single-dose SSM 30 mcg
EXPERIMENTAL: Treatment C; 2 consecutive doses of SSM 15 mcg administered 20 minute apart	Drug: Treatment C: SSM 15 mcg; 2 consecutive doses of SSM 15 mcg administered 20 minutes apart
EXPERIMENTAL: Treatment D; 12 consecutive doses of SSM 30 mcg administered 1 hour apart	Drug: Treatment D: SSM 30 mcg; 12 consecutive doses of SSM 30 mcg administered 1 hour apart

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under the Curve	Area under the plasma concentration time curve	9 days, not including a 30 day screening window

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
C max	Maximum plasma concentration	9 days
T max	Time to reach maximum plasma concentration	9 days
Context Sensitive Half-Time (CST½)		9 hours

Collaborators and Investigators

• Sponsor: AcelRx Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (ACTUAL): May 1, 2014
• Study Completion (ACTUAL): May 1, 2014

Study Registration Dates

• First Submitted: March 6, 2014
• First Submitted That Met QC Criteria: March 7, 2014
• First Posted (ESTIMATE): March 10, 2014

Study Record Updates

• Last Update Posted (ACTUAL): July 17, 2018
• Last Update Submitted That Met QC Criteria: July 16, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Plasma concentrations
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Sufentanil
• Other Study ID Numbers: SAP101