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Initial analysis of results warranted a study re-design and work on the study was suspended.
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| Name | Class |
|---|---|
| Neuropsychiatric Research Institute, Fargo, North Dakota | OTHER |
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This study is to compare intestinal Cytochrome P450 3A4 (CYP3A4) activity in 9-18 month post weight loss surgery Roux-en-Y Gastric Bypass (RYGB) versus control subjects who have not had a weight loss surgery and are of similar age, gender, body mass index as the gastric bypass group. For this purpose, we will compare post-bariatric surgery patients with control subjects on alterations in systemic exposure of buspirone, a CYP3A4 substrate, when administered with grapefruit juice, a selective intestinal CYP3A4 inhibitor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Buspirone | Experimental | Buspirone alone |
|
| Buspirone plus grapefruit juice | Active Comparator | Buspirone plus grapefruit juice |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Buspirone | Drug | The primary aim of this study is to compare the relative difference between the area-under-the-curve (AUC) of buspirone alone (buspirone) with the AUC of buspirone in the presence of grapefruit juice (buspirone + GFJ) in patients who underwent RYGB 9-18 months prior versus a control group of participants who have not undergone bariatric surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Area-under-the-curve | The primary aim of this study is to compare the relative difference between the area-under-the-curve (AUC) of buspirone alone (buspirone) with the AUC of buspirone in the presence of grapefruit juice (buspirone + GFJ) in patients who underwent RYGB 9-18 months prior versus a control group of participants who have not undergone bariatric surgery. | 9-18 months following RYGB |
| Measure | Description | Time Frame |
|---|---|---|
| Composite of pharmacokinetic measures compared between buspirone and buspirone with grapefruit juice in participants who have undergone RYGB and nonsurgical control participants. | General pharmacokinetic comparisons (Cmax, Tmax, half-life, etc.) will be made between the two conditions. | 9-18 months following RYGB |
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Inclusion Criteria:
Exclusion Criteria:
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| Buspirone and Grapefruit Juice | Drug | Grapefruit juice will be given before and during buspirone administration to inhibit intestinal CYP3A4. |
|
| Compare GLP-2 levels between the buspirone and buspirone with grapefruit juice in participants who have undergone RYGB and nonsurgical control participants. |
To compare GLP-2 levels between participants and drug conditions. |
| 9-18 months following RYGB |
| ID | Term |
|---|---|
| D002065 | Buspirone |
| ID | Term |
|---|---|
| D013141 | Spiro Compounds |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
| D011083 | Polycyclic Compounds |
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