Trial Outcomes & Findings for Alfentanil: Simultaneous Testing Pilot (NCT NCT01008059)
NCT ID: NCT01008059
Last Updated: 2019-05-17
Results Overview
AUC(0-inf)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
6 participants
Primary outcome timeframe
9 hours
Results posted on
2019-05-17
Participant Flow
Participant milestones
| Measure |
Control Sequential Alfentanil
Alfentanil (IV bolus) followed 3 hours later by oral deuterium-labeled (d3) alfentanil. Control.
|
Rifampin Sequential Alfentanil
Alfentanil (IV bolus) followed 3 hours later by oral deuterium-labeled (d3) alfentanil after 5d rifampin pretreatment
|
Grapefruit Juice Sequential Alfentanil
Alfentanil (IV bolus) followed 3 hours later by oral deuterium-labeled (d3) alfentanil after 3 oz double strength oral grapefruit juice
|
Ketoconazole Sequential Alfentanil
Alfentanil (IV bolus) followed 3 hours later by oral deuterium-labeled (d3) alfentanil after 3d ketoconazole
|
Control Simultaneous Alfentanil
Alfentanil (IV bolus) and simultaneous oral deuterium-labeled (d3) alfentanil.Control.
|
Rifampin Simultaneous Alfentanil
Alfentanil (IV bolus) and simultaneous oral deuterium-labeled (d3) alfentanil after 5d rifampin pretreatment
|
Grapefruit Juice Simultaneous Alfentanil
Alfentanil (IV bolus) and simultaneous oral deuterium-labeled (d3) alfentanil after 3 oz double strength oral grapefruit juice
|
Ketoconazole Simultaneous Alfentanil
Alfentanil (IV bolus) and simultaneous oral deuterium-labeled (d3) alfentanil after 3d ketoconazole
|
|---|---|---|---|---|---|---|---|---|
|
Control Sequential Alfentanil
STARTED
|
6
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Control Sequential Alfentanil
COMPLETED
|
6
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Control Sequential Alfentanil
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Rifampin Sequential Alfentanil
STARTED
|
0
|
6
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Rifampin Sequential Alfentanil
COMPLETED
|
0
|
6
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Rifampin Sequential Alfentanil
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Grapefruit Juice Sequential Alfentanil
STARTED
|
0
|
0
|
6
|
0
|
0
|
0
|
0
|
0
|
|
Grapefruit Juice Sequential Alfentanil
COMPLETED
|
0
|
0
|
6
|
0
|
0
|
0
|
0
|
0
|
|
Grapefruit Juice Sequential Alfentanil
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Ketoconazole Sequential Alfentanil
STARTED
|
0
|
0
|
0
|
6
|
0
|
0
|
0
|
0
|
|
Ketoconazole Sequential Alfentanil
COMPLETED
|
0
|
0
|
0
|
6
|
0
|
0
|
0
|
0
|
|
Ketoconazole Sequential Alfentanil
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Control Simultaneous Alfentanil
STARTED
|
0
|
0
|
0
|
0
|
6
|
0
|
0
|
0
|
|
Control Simultaneous Alfentanil
COMPLETED
|
0
|
0
|
0
|
0
|
6
|
0
|
0
|
0
|
|
Control Simultaneous Alfentanil
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Rifampin Simultaneous Alfentanil
STARTED
|
0
|
0
|
0
|
0
|
0
|
6
|
0
|
0
|
|
Rifampin Simultaneous Alfentanil
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
6
|
0
|
0
|
|
Rifampin Simultaneous Alfentanil
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Grapefruit Juice Simultaneous Alfentanil
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
6
|
0
|
|
Grapefruit Juice Simultaneous Alfentanil
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
6
|
0
|
|
Grapefruit Juice Simultaneous Alfentanil
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Ketoconazole Simultaneous Alfentanil
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
6
|
|
Ketoconazole Simultaneous Alfentanil
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
6
|
|
Ketoconazole Simultaneous Alfentanil
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Alfentanil: Simultaneous Testing Pilot
Baseline characteristics by cohort
| Measure |
Alfentanil
n=6 Participants
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=39 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=39 Participants
|
PRIMARY outcome
Timeframe: 9 hoursAUC(0-inf)
Outcome measures
| Measure |
Alfentanil
n=6 Participants
|
|---|---|
|
Area Under the Curve of Alfentanil Concentration vs. Time Extrapolated to Infinity
Simultaneous Control
|
58 (hr*ng/ml/mg)
Standard Deviation 15
|
|
Area Under the Curve of Alfentanil Concentration vs. Time Extrapolated to Infinity
Simultaneous Rifampin
|
57 (hr*ng/ml/mg)
Standard Deviation 9
|
|
Area Under the Curve of Alfentanil Concentration vs. Time Extrapolated to Infinity
Simultaneous Grapefruit
|
55 (hr*ng/ml/mg)
Standard Deviation 12
|
|
Area Under the Curve of Alfentanil Concentration vs. Time Extrapolated to Infinity
Simultaneous ketoconazole
|
73 (hr*ng/ml/mg)
Standard Deviation 26
|
|
Area Under the Curve of Alfentanil Concentration vs. Time Extrapolated to Infinity
Sequential Control
|
59 (hr*ng/ml/mg)
Standard Deviation 27
|
|
Area Under the Curve of Alfentanil Concentration vs. Time Extrapolated to Infinity
Sequential Rifampin
|
54 (hr*ng/ml/mg)
Standard Deviation 10
|
|
Area Under the Curve of Alfentanil Concentration vs. Time Extrapolated to Infinity
Sequential Grapefruit
|
59 (hr*ng/ml/mg)
Standard Deviation 31
|
|
Area Under the Curve of Alfentanil Concentration vs. Time Extrapolated to Infinity
Sequential Ketoconazole
|
73 (hr*ng/ml/mg)
Standard Deviation 19
|
Adverse Events
Control Sequential Alfentanil
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Refampin Sequential Alfentanil
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Grapefruit Juice Sequential Alfentanil
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Ketoconazole Sequential Alfentanil
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Simultaneous Alfentanil
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Rifampin Simultaneous Alfentanil
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Grapefruit Juice Simultaneous Alfentanil
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ketoconazole Simultaneous Alfentanil
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Control Sequential Alfentanil
n=6 participants at risk
Alfentanil (IV bolus) followed 3 hours later by oral deuterium-labeled (d3) alfentanil. Control.
|
Refampin Sequential Alfentanil
n=6 participants at risk
Alfentanil (IV bolus) followed 3 hours later by oral deuterium-labeled (d3) alfentanil after 5d rifampin pretreatment
|
Grapefruit Juice Sequential Alfentanil
n=6 participants at risk
Alfentanil (IV bolus) followed 3 hours later by oral deuterium-labeled (d3) alfentanil after 3 oz double strength oral grapefruit juice
|
Ketoconazole Sequential Alfentanil
n=6 participants at risk
Alfentanil (IV bolus) followed 3 hours later by oral deuterium-labeled (d3) alfentanil after 3d ketoconazole
|
Control Simultaneous Alfentanil
n=6 participants at risk
Alfentanil (IV bolus) and simultaneous oral deuterium-labeled (d3) alfentanil.Control
|
Rifampin Simultaneous Alfentanil
n=6 participants at risk
Alfentanil (IV bolus) and simultaneous oral deuterium-labeled (d3) alfentanil after 5d rifampin pretreatment
|
Grapefruit Juice Simultaneous Alfentanil
n=6 participants at risk
Alfentanil (IV bolus) and simultaneous oral deuterium-labeled (d3) alfentanil after 3 oz double strength oral grapefruit juice
|
Ketoconazole Simultaneous Alfentanil
n=6 participants at risk
Alfentanil (IV bolus) and simultaneous oral deuterium-labeled (d3) alfentanil after 3d ketoconazole
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea/Vomitting
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
16.7%
1/6 • Number of events 1 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place