Pharmacokinetics of Sufentanil Sublingual Microtablet 30 mcg and 15 mcg in Healthy Subjects
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 healthy
Started May 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 6, 2014
CompletedFirst Posted
Study publicly available on registry
March 10, 2014
CompletedStudy Start
First participant enrolled
May 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedJuly 17, 2018
July 1, 2018
Same day
March 6, 2014
July 16, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Area Under the Curve
Area under the plasma concentration time curve
9 days, not including a 30 day screening window
Other Outcomes (3)
C max
9 days
T max
9 days
Context Sensitive Half-Time (CST½)
9 hours
Study Arms (4)
Treatment A
ACTIVE COMPARATORSufenta® IV (50 mcg/mL) 30 mcg infused over 1 minute
Treatment B
EXPERIMENTALSingle dose of SSM 30 mcg
Treatment C
EXPERIMENTAL2 consecutive doses of SSM 15 mcg administered 20 minute apart
Treatment D
EXPERIMENTAL12 consecutive doses of SSM 30 mcg administered 1 hour apart
Interventions
Sufenta® intravenous (IV) (50 mcg/mL) 30 mcg infused over 1 minute
2 consecutive doses of SSM 15 mcg administered 20 minutes apart
Eligibility Criteria
You may qualify if:
- Non-smoking male or female subjects
- Aged between 18 and 45 years inclusive
- Subjects must have Body Mass Index (BMI) between 18 and 30, inclusively.
You may not qualify if:
- 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
- Female subjects who are pregnant
- Subjects with chronic obstructive pulmonary disease, sleep apnea, or other significant respiratory disorders
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Talphera, Inclead
Study Sites (1)
PRA
Lenexa, Kansas, 66219, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Sandra K. Willsie, D.O.
PRA
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 6, 2014
First Posted
March 10, 2014
Study Start
May 1, 2014
Primary Completion
May 1, 2014
Study Completion
May 1, 2014
Last Updated
July 17, 2018
Record last verified: 2018-07