Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 53 of 7564 for:    Area Under Curve

Mechanistic Investigation Of Intestinal Cytochrome p450 3A4 Following Roux-en-Y Surgery And Its Effect on Plasma Concentrations of Buspirone

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02483598
Recruitment Status : Terminated (Initial analysis of results warranted a study re-design and work on the study was suspended.)
First Posted : June 29, 2015
Last Update Posted : August 24, 2018
Sponsor:
Collaborator:
Neuropsychiatric Research Institute, Fargo, North Dakota
Information provided by (Responsible Party):
Kristine Steffen, North Dakota State University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Gastric Bypass Drug: Buspirone Drug: Buspirone and Grapefruit Juice Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Study Start Date : June 2015
Actual Primary Completion Date : June 2018
Actual Study Completion Date : June 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Buspirone
Buspirone alone
Drug: Buspirone
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.

Drug: Buspirone and Grapefruit Juice
Grapefruit juice will be given before and during buspirone administration to inhibit intestinal CYP3A4.

Active Comparator: Buspirone plus grapefruit juice
Buspirone plus grapefruit juice
Drug: Buspirone
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.

Drug: Buspirone and Grapefruit Juice
Grapefruit juice will be given before and during buspirone administration to inhibit intestinal CYP3A4.




Primary Outcome Measures :
  1. Area-under-the-curve [ Time Frame: 9-18 months following RYGB ]
    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.


Secondary Outcome Measures :
  1. Composite of pharmacokinetic measures compared between buspirone and buspirone with grapefruit juice in participants who have undergone RYGB and nonsurgical control participants. [ Time Frame: 9-18 months following RYGB ]
    General pharmacokinetic comparisons (Cmax, Tmax, half-life, etc.) will be made between the two conditions.

  2. Compare GLP-2 levels between the buspirone and buspirone with grapefruit juice in participants who have undergone RYGB and nonsurgical control participants. [ Time Frame: 9-18 months following RYGB ]
    To compare GLP-2 levels between participants and drug conditions.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male or Female
  2. Age 18-65 (inclusive, at time of informed consent)
  3. No tobacco use in the past three months.
  4. Underwent Roux-en-Y Gastric Bypass weight loss surgery 9-18 months prior to study OR has not had a weight loss surgery but matches the gastric bypass patients on age, gender, and BMI.
  5. Ability to read, write and understand English.
  6. Expresses the ability/willingness to consume grapefruit juice.

Exclusion Criteria:

  1. Taking a medication that has a clinically significant interaction with buspirone or grapefruit juice or an interaction that may alter the study data.
  2. Hypersensitivity to buspirone or any excipient contained within the dosage forms or grapefruit juice.
  3. Inability to tolerate repeated blood draws.
  4. Any history of bipolar disorder or a psychotic disorder.
  5. Current major depressive disorder or current suicidality.
  6. Alcohol or substance dependence in the past year.
  7. Currently pregnant or lactating or unwillingness to use medically accepted contraception during study.
  8. Taking a medication which significantly alters gastrointesinal transit time.
  9. Medical conditon which may increase participant risk with buspirone or grapefruit juice.
  10. Self reported history of viral hepatits or HIV.
  11. Positive urine drug screen unless documented prescription of a non-interacting medication.
  12. Renal impairment as evidenced by an estimated glomerular filtration rate (eGFR) of less than or equal to 60 ml/min/1.73 m2 or other abnormality on a renal panel that the medical provider feels puts the participant at risk.
  13. Hepatic insufficiency as defined by any hepatic enzyme greater than 3x the upper limit of normal or other hepatic laboratory abnormalities at the discretion of the medical provider.
  14. Any contraindication to bioelectrical impedance analysis (BIA) such as pregnancy, the presence of a pacemaker or other implanted mechanical device.

Layout table for additonal information
Responsible Party: Kristine Steffen, Associate Professor, North Dakota State University
ClinicalTrials.gov Identifier: NCT02483598     History of Changes
Other Study ID Numbers: bus-000
First Posted: June 29, 2015    Key Record Dates
Last Update Posted: August 24, 2018
Last Verified: August 2018
Keywords provided by Kristine Steffen, North Dakota State University:
buspirone
pharmacokinetics
Cytochrome P450 3A4
Additional relevant MeSH terms:
Layout table for MeSH terms
Buspirone
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action