Bariatric Surgery
Conditions
Keywords
Gastric Bypass, Duloxetine, Cymbalta, Pharmacokinetics
Brief summary
This study aims to determine the difference, if any, in the pharmacokinetics of duloxetine between patients who are nine to fifteen months post Roux-en-Y Bariatric Surgery and control subjects matched for body mass index (BMI), age and gender.
Interventions
DRUGDuloxetine
Single dose of 60 mg of duloxetine
Sponsors
University of North Dakota
Eli Lilly and Company
Neuropsychiatric Research Institute, Fargo, North Dakota
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female subjects between the ages of 18 and 60 years. * Subjects must be of good general health by history and physical exam. * Ten experimental subjects 9 to 15 months post bariatric surgery (Roux-en-Y procedure), no BMI requirement. * Ten normal control subjects who have met the inclusion criteria and have not received bariatric surgery and who are matched to the surgery subjects according to body mass index, age and sex. * Women of child bearing potential must be practicing an accepted method of birth control (barrier method or oral contraceptive) and have a negative pregnancy test at baseline. * No contraindications to receiving a single capsule of 60 mg of duloxetine
Exclusion criteria
* Allergy to duloxetine or any of its constituents. * Candidates who are pregnant or nursing * Candidates currently receiving any antidepressant. * Candidates that are determined to be poor metabolizers for CYP2D6 * Subjects who smoke or use any nicotine products * Candidates currently receiving a medication that interacts with duloxetine. * Candidates experiencing clinically significant, unstable neurological, hepatic, renal or cardiovascular disease. * Candidates experiencing or with a history of vomiting or diarrhea associated with bariatric surgery * Candidates currently or with a past history of meeting DSM-IV diagnostic criteria for schizophrenia, schizoaffective disorder, bipolar disorder. * Candidates who have participated in an investigational drug study in past 30 days. * Candidates who meet DSM-IV diagnostic criteria for drug/alcohol abuse or dependency or who have a history of drug/alcohol abuse or dependency.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax | 0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.25, 2.5, 3.5, 4.5, 6.5, 8.5, 10.5, 24, 48. 72 | The difference, if any, in the pharmacokinetics parameters (Cmax) of duloxetine between patients who are nine to fifteen months post Roux-en-Y Bariatric Surgery and control subjects matched for BMI, age and gender. |
| Tmax | 0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.25, 2.5, 3.5, 4.5, 6.5, 8.5, 10.5, 24, 48. 72 | Time to maximum plasma concentration |
| AUCo-inf, | 0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.25, 2.5, 3.5, 4.5, 6.5, 8.5, 10.5, 24, 48. 72 | Area under the plasma concentration time curve |
| T1/2 | 0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.25, 2.5, 3.5, 4.5, 6.5, 8.5, 10.5, 24, 48. 72 | Half life |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Emesis | 4 days | episodes of emesis. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bariatric Subjects 1 year post bariatric surgery 9 to 15 months post-RYGBP | 10 |
| Control Subjects matched to the bariatric subjects via BMI, age and gender | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | Bariatric | Control | Total |
|---|---|---|---|
| Age, Continuous | 44.10 years STANDARD_DEVIATION 9.02 | 45.9 years STANDARD_DEVIATION 8.54 | 45 years STANDARD_DEVIATION 8.78 |
| Region of Enrollment United States | 10 participants | 10 participants | 20 participants |
| Sex: Female, Male Female | 9 Participants | 9 Participants | 18 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 10 | 3 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
Primary
AUCo-inf,
Area under the plasma concentration time curve
Time frame: 0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.25, 2.5, 3.5, 4.5, 6.5, 8.5, 10.5, 24, 48. 72
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bariatric | AUCo-inf, | 646.74 ng h/mL | Standard Deviation 79.7 |
| Control | AUCo-inf, | 1119.91 ng h/mL | Standard Deviation 593.4 |
Primary
Cmax
The difference, if any, in the pharmacokinetics parameters (Cmax) of duloxetine between patients who are nine to fifteen months post Roux-en-Y Bariatric Surgery and control subjects matched for BMI, age and gender.
Time frame: 0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.25, 2.5, 3.5, 4.5, 6.5, 8.5, 10.5, 24, 48. 72
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bariatric | Cmax | 51.04 ng/ml | Standard Deviation 11.88 |
| Control | Cmax | 61.41 ng/ml | Standard Deviation 34.93 |
Primary
T1/2
Half life
Time frame: 0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.25, 2.5, 3.5, 4.5, 6.5, 8.5, 10.5, 24, 48. 72
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bariatric | T1/2 | 12.0 hours | Standard Deviation 0.87 |
| Control | T1/2 | 11.75 hours | Standard Deviation 2.38 |
Primary
Tmax
Time to maximum plasma concentration
Time frame: 0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.25, 2.5, 3.5, 4.5, 6.5, 8.5, 10.5, 24, 48. 72
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bariatric | Tmax | 2.2 Hours | Standard Deviation 0.86 |
| Control | Tmax | 6 Hours | Standard Deviation 2.17 |
Secondary
Emesis
episodes of emesis.
Time frame: 4 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bariatric | Emesis | 2 number of occurences |
| Control | Emesis | 3 number of occurences |