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

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ClinicalTrials.gov Identifier: NCT02082236
Recruitment Status : Completed
First Posted : March 10, 2014
Last Update Posted : July 17, 2018
Sponsor:
Information provided by (Responsible Party):
AcelRx Pharmaceuticals, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Treatment Arm A: Sufenta® Drug: Treatment B: Sufentanil SSM 30 mcg Drug: Treatment C: SSM 15 mcg Drug: Treatment D: SSM 30 mcg Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Pharmacokinetics of Sufentanil Sublingual Microtablet 30 mcg and 15 mcg in Healthy Subjects
Study Start Date : May 2014
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Area Under the Curve [ Time Frame: 9 days, not including a 30 day screening window ]
    Area under the plasma concentration time curve


Other Outcome Measures:
  1. C max [ Time Frame: 9 days ]
    Maximum plasma concentration

  2. T max [ Time Frame: 9 days ]
    Time to reach maximum plasma concentration

  3. Context Sensitive Half-Time (CST½) [ Time Frame: 9 hours ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02082236


Locations
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United States, Kansas
PRA
Lenexa, Kansas, United States, 66219
Sponsors and Collaborators
AcelRx Pharmaceuticals, Inc.
Investigators
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Principal Investigator: Sandra K. Willsie, D.O. PRA
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Responsible Party: AcelRx Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02082236    
Other Study ID Numbers: SAP101
First Posted: March 10, 2014    Key Record Dates
Last Update Posted: July 17, 2018
Last Verified: July 2018
Keywords provided by AcelRx Pharmaceuticals, Inc.:
Plasma concentrations
Additional relevant MeSH terms:
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Sufentanil
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics