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

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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

Tracking Information
First Submitted Date  ICMJE June 22, 2015
First Posted Date  ICMJE June 29, 2015
Last Update Posted Date August 24, 2018
Study Start Date  ICMJE June 2015
Actual Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 24, 2015)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02483598 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 24, 2015)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mechanistic Investigation Of Intestinal Cytochrome p450 3A4 Following Roux-en-Y Surgery And Its Effect on Plasma Concentrations of Buspirone
Official Title  ICMJE Not Provided
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Gastric Bypass
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: Buspirone
    Buspirone alone
    Interventions:
    • Drug: Buspirone
    • Drug: Buspirone and Grapefruit Juice
  • Active Comparator: Buspirone plus grapefruit juice
    Buspirone plus grapefruit juice
    Interventions:
    • Drug: Buspirone
    • Drug: Buspirone and Grapefruit Juice
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Estimated Enrollment  ICMJE
 (submitted: June 24, 2015)
12
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2018
Actual Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02483598
Other Study ID Numbers  ICMJE bus-000
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kristine Steffen, North Dakota State University
Study Sponsor  ICMJE North Dakota State University
Collaborators  ICMJE Neuropsychiatric Research Institute, Fargo, North Dakota
Investigators  ICMJE Not Provided
PRS Account North Dakota State University
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP