Gastric BypassPhase 4NCT02483598
Mechanistic Investigation Of Intestinal Cytochrome p450 3A4 Following Roux-en-Y Surgery And Its Effect on Plasma Concentrations of Buspirone
A Phase 4 study testing Buspirone and Buspirone and Grapefruit Juice in people with Gastric Bypass, run by North Dakota State University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastric Bypass
- What is being tested?
- Buspirone and Buspirone and Grapefruit Juice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to Jun 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or Female
- Age 18-65 (inclusive, at time of informed consent)
- No tobacco use in the past three months.
- 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.
- Ability to read, write and understand English.
- Expresses the ability/willingness to consume grapefruit juice.
Who cannot join
- Taking a medication that has a clinically significant interaction with buspirone or grapefruit juice or an interaction that may alter the study data.
- Hypersensitivity to buspirone or any excipient contained within the dosage forms or grapefruit juice.
- Inability to tolerate repeated blood draws.
- Any history of bipolar disorder or a psychotic disorder.
- Current major depressive disorder or current suicidality.
- Alcohol or substance dependence in the past year.
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- Currently pregnant or lactating or unwillingness to use medically accepted contraception during study.
- Taking a medication which significantly alters gastrointesinal transit time.
- Medical conditon which may increase participant risk with buspirone or grapefruit juice.
- Self reported history of viral hepatits or HIV.
- Positive urine drug screen unless documented prescription of a non-interacting medication.
- 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.
- 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.
- Any contraindication to bioelectrical impedance analysis (BIA) such as pregnancy, the presence of a pacemaker or other implanted mechanical device.
About this study
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.
- Conditions
- Gastric Bypass
- Being tested
- Buspirone, Buspirone and Grapefruit Juice
- Keywords
- buspirone, pharmacokinetics, Cytochrome P450 3A4
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BuspironeDrug
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.
Buspirone and Grapefruit JuiceDrug
Grapefruit juice will be given before and during buspirone administration to inhibit intestinal CYP3A4.
| Study group | Role | What they receive |
|---|---|---|
| Buspirone | Experimental | Buspirone alone Receives: Drug: Buspirone; Drug: Buspirone and Grapefruit Juice |
| Buspirone plus grapefruit juice | Active comparator | Buspirone plus grapefruit juice Receives: Drug: Buspirone; Drug: Buspirone and Grapefruit Juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 9-18 months following RYGB
Secondary outcomes (2)
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.
Measured: 9-18 months following RYGB
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.
Measured: 9-18 months following RYGB
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionJun 2018
- Study completionJun 2018
Why it stopped: Initial analysis of results warranted a study re-design and work on the study was suspended.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric BypassStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- North Dakota State University
- Sponsor type
- University, hospital or other
- Collaborators
- Neuropsychiatric Research Institute, Fargo, North Dakota
- Responsible party
- Principal investigator, Kristine Steffen, North Dakota State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02483598
- Sponsor's protocol ID
- bus-000
- Status last verified
- Aug 2018
- First submitted
- 22 Jun 2015
- Last updated
- 24 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanistic Investigation Of Intestinal Cytochrome p450 3A4 Following Roux-en-Y Surgery And Its Effect on Plasma Concentrations of Buspirone
- ClinicalTrials.gov ID
- NCT02483598
- Acronym / sponsor ID
- bus-000
- Conditions
- Gastric Bypass
- Keywords
- buspirone, pharmacokinetics, Cytochrome P450 3A4
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Initial analysis of results warranted a study re-design and work on the study was suspended.
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- North Dakota State UniversityUniversity, hospital or other
- Collaborators
- Neuropsychiatric Research Institute, Fargo, North Dakota
- Study start
- Jun 2015
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 29 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Buspirone | Experimental | Drug: Buspirone, Drug: Buspirone and Grapefruit JuiceBuspirone alone |
| Buspirone plus grapefruit juice | Active comparator | Drug: Buspirone, Drug: Buspirone and Grapefruit JuiceBuspirone plus grapefruit juice |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or Female
- Age 18-65 (inclusive, at time of informed consent)
- No tobacco use in the past three months.
- 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.
- Ability to read, write and understand English.
Key exclusion criteria (14 listed)
- Taking a medication that has a clinically significant interaction with buspirone or grapefruit juice or an interaction that may alter the study data.
- Hypersensitivity to buspirone or any excipient contained within the dosage forms or grapefruit juice.
- Inability to tolerate repeated blood draws.
- Any history of bipolar disorder or a psychotic disorder.
- Current major depressive disorder or current suicidality.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BuspironeThe 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, Buspirone plus grapefruit juice |
| Buspirone and Grapefruit JuiceGrapefruit juice will be given before and during buspirone administration to inhibit intestinal CYP3A4. | Drug | Buspirone, Buspirone plus grapefruit juice |
Primary outcome
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.
2 secondary outcomes
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
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
Results and safety
The study was stopped early (reason given: Initial analysis of results warranted a study re-design and work on the study was suspended.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Buspirone and Buspirone and Grapefruit Juice in people with Gastric Bypass, run by North Dakota State University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Initial analysis of results warranted a study re-design and work on the study was suspended.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area-under-the-curve (time frame: 9-18 months following RYGB). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2018.