ObesityPhase 4NCT04049786
Impact of Bariatric Surgery on Pharmacokinetic Study of Simvastatin and Carvedilol
A Phase 4 study testing Digestive biopsy, Carvedilol 25mg and Serial blood sampling for PK analysis in people with Obesity and Bariatric Surgery, run by Natalia Valadares de Moraes at 1 site in United States.
Trial summary
Obesity affects more than 1 in 3 adults in the U.S. It is commonly associated with reduced quality of life and complications such as metabolic syndrome, heart disease, high blood pressure and sleep disorders. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Bariatric Surgery, Roux-en Y Gastric Bypass
- What is being tested?
- Digestive biopsy, Carvedilol 25mg and Serial blood sampling for PK analysis
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2019to Aug 2023
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of both gender with 18 to 65 years old.
- Healthy volunteers group: body mass index lower or equal to 35 kg/mˆ2.
- Obese group: body mass index higher than 30 kg/mˆ2.
- Post-RYGB group: patients previously submitted to Roux-en-Y gastric bypass bariatric surgery (6-48 months before the study).
Who cannot join
- Pregnant and lactating patients.
- Patients with serum creatinine higher than 1,5 mg/dL.
- Patients with previous altered coagulation.
- Patients with previous cancer history (on the last year).
- Patients with previous hypersensitivity history to simvastatin or carvedilol.
- Patients who were in use of any anticoagulant (heparin, low molecular weight heparin, aspirin, nonsteroidal antiinflammatory drugs).
Show all 9Show fewer
- Patients who were in use of CYP3A4 or P-glycoprotein inhibitors or inducers.
- For carvedilol study: patients who were in use of CYP2D6 inhibitors; poor metabolizer phenotype of CYP2D6 and genotyped as CYP2C9*3/*3.
- Patients who disagree to continue the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Roux-en-Y Gastric Bypass (RYGB) Bariatric Surgery on System Pharmacology: Single-dose Cross-over Pharmacokinetic Study of Simvastatin and Carvedilol.
Obesity affects more than 1 in 3 adults in the U.S. It is commonly associated with reduced quality of life and complications such as metabolic syndrome, heart disease, high blood pressure and sleep disorders. The gastric bypass, also known as Roux-en-Y gastric bypass (RYGB), is one of the most common weight-loss surgeries due to the reliable and long-lasting weight loss and the effective remission of obesity-associated conditions. Although the impact of obesity on absorption, distribution, metabolism and excretion has been documented for several drugs, label recommendations might not account for specific population subgroups, specially morbidly obese patients and obese patients post-bariatric surgery. This study aims to investigate the impact of obesity and RYGB surgery on the kinetic disposition of simvastatin (Study A) and carvedilol (Study B).
Read the detailed description
The study is ongoing and eligible subjects are enrolled after signing a written informed consent. Research participants (n=120, in total) include healthy volunteers [body mass index (BMI) ≤ 25 kg/m2], obese [BMI > 30 kg/m2] and patients that underwent RYGB surgery 6-60 month prior this research protocol. On day 1, participants receive a single oral dose of 40 mg simvastatin (Study A) or 25 mg racemic carvedilol (Study B). Serial blood samples are collected up to 24 h for the pharmacokinetic analysis. Blood tests (blood count, fasting blood glucose, lipid profile, serum creatinine, urea, gamma-glutamyl transferase, aspartate aminotransferase and alanine amino transferase) are being monitored for all enrolled participants. Blood samples are also collected for genotyping the main genetic polymorphisms associated with carvedilol or simvastatin pharmacokinetics. Metoprolol is being used as a probe drug for CYP2D6 in vivo phenotyping only for research participants enrolled in Study B. After oral administration of metoprolol (on day 2), urine samples are being collected up to 8h after drug administration to determine the urinary metabolic ratio α-hydroxy metoprolol/metoprolol. As part of the pre-surgery evaluation (obese group) or post-surgery follow-up (RYGB group), obese patients and patients post-RYGB are submitted to digestive endoscopies. Healthy participants will not undergo endoscopic examination. The preparation protocol for digestive endoscopy includes: a) 8-hour fasting; b) 10% spray lidocaine (topical); c) oral simethicone (75 mg/ml, 80 drops); d) oxygen therapy depending on the patient (nasal catheter with O2 at 3 L/min); e) 0.02 to 0.03 mg/kg intravenous midazolam; f) 50 mg pethidine. A blood sample is collected 4-h after intravenous midazolam for in vivo CYP3A4 phenotyping. During the endoscopies, duodenum and jejunum biopsies are being collected to investigated interindividual variability related to drug oral bioavailability (only obese and post-RYGB research participants). Samples collected from digestive biopsies will be used to develop individual enteroid microfluidic systems. In vivo phenotyping of drug metabolizing enzymes and transporters will also be assessed by transcriptome using blood samples. The generated in vitro and in vivo data will be combined to build up physiologically based pharmacokinetic models for precision dosing in obese and post-RYGB patients.
- Conditions
- Obesity, Bariatric Surgery, Roux-en Y Gastric Bypass
- Being tested
- Digestive biopsy, Carvedilol 25mg, Serial blood sampling for PK analysis, Metoprolol 100 mg for CYP2D6 phenotyping, Simvastatin 40mg
- Keywords
- Bariatric surgery, Pharmacokinetics, RYGB, CYP2D6, CYP3A4
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digestive biopsyProcedure or surgery
All patients with indication for RYGB bariatric surgery undergo to endoscopy before and after the surgery as standard protocol. Digestive biopsy are being performed in obese and post-RYGB patients for transcriptomic analysis
Carvedilol 25mgDrug
Single-dose of carvedilol 25 mg are being administrated orally.
Serial blood sampling for PK analysisProcedure or surgery
Serial blood samples are being collected at times 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18 and 24 hours after drug administration for PK evaluation .
Metoprolol 100 mg for CYP2D6 phenotypingDrug
Metoprolol is being used as probe drug to evaluate CYP2D6 activity. Single-dose of metoprolol 100 mg are being administrated orally.
Simvastatin 40mgDrug
Also called SVA
Single-dose of simvastatin 40 mg are being administrated orally.
Midazolam 2 mg for CYP3A4 phenotypingDrug
Also called MDZ
Midazolam is being used as probe drug to evaluate CYP3A4 activity. Single-dose of midazolam 2 mg are being administrated intravenous.
GenotypingOther
Patients are being genotyped for the main SNP on CYP2C9, ABCB1, SLCO1B1 and CYP2D6 genes using blood samples
| Study group | Role | What they receive |
|---|---|---|
| Simvastatin - Healthy volunteers | Active comparator | Adult patients (18-65 years old) with body mass index < 25 kg/mˆ2 treated with a single oral dose of 40 mg simvastatin for Pk analysis. Blood samples collected for blood tests, genomics and transcriptomic analysis Receives: Procedure: Serial blood sampling for PK analysis; Drug: Metoprolol 100 mg for CYP2D6 phenotyping; Drug: Simvastatin 40mg; Drug: Midazolam 2 mg for CYP3A4 phenotyping; Other: Genotyping |
| Carvedilol Study - Healthy volunteers | Active comparator | Adult patients (18-65 years old) with body mass index < 25 kg/mˆ2 treated with a single oral dose of 25 mg carvedilol for Pk analysis. Blood samples collected for blood tests, genomics and transcriptomic analysis Receives: Drug: Carvedilol 25mg; Procedure: Serial blood sampling for PK analysis; Drug: Metoprolol 100 mg for CYP2D6 phenotyping; Drug: Midazolam 2 mg for CYP3A4 phenotyping; Other: Genotyping |
| Simvastatin - Obese | Active comparator | Adult patients (18-65 years old) with body mass index > 30 kg/mˆ2 treated with a single oral dose of 40 mg simvastatin for Pk analysis. Blood samples collected for blood tests, genomics and transcriptomic analysis. Receives: Procedure: Digestive biopsy; Procedure: Serial blood sampling for PK analysis; Drug: Metoprolol 100 mg for CYP2D6 phenotyping; Drug: Simvastatin 40mg; Drug: Midazolam 2 mg for CYP3A4 phenotyping; Other: Genotyping |
| Carvedilol study - Obese | Active comparator | Adult patients (18-65 years old) with body mass index > 30 kg/mˆ2 treated with a single oral dose of 25 mg carvedilol for Pk analysis. Blood samples collected for blood tests, genomics and transcriptomic analysis. Receives: Procedure: Digestive biopsy; Drug: Carvedilol 25mg; Procedure: Serial blood sampling for PK analysis; Drug: Metoprolol 100 mg for CYP2D6 phenotyping; Drug: Midazolam 2 mg for CYP3A4 phenotyping; Other: Genotyping |
| Simvastatin - Post-RYGB | Active comparator | Adult patients (18-65 years old) previously submitted to RYGB surgery treated with a single oral dose of 40 mg simvastatin for Pk analysis. Blood samples collected for blood tests, genomics and transcriptomic analysis. Receives: Procedure: Digestive biopsy; Procedure: Serial blood sampling for PK analysis; Drug: Metoprolol 100 mg for CYP2D6 phenotyping; Drug: Simvastatin 40mg; Drug: Midazolam 2 mg for CYP3A4 phenotyping; Other: Genotyping |
| Carvedilol - Post-RYGB | Active comparator | Adult patients (18-65 years old) previously submitted to RYGB surgery treated with a single oral dose of 25 mg carvedilol for Pk analysis. Blood samples collected for blood tests, genomics and transcriptomic analysis. Receives: Procedure: Digestive biopsy; Drug: Carvedilol 25mg; Procedure: Serial blood sampling for PK analysis; Drug: Metoprolol 100 mg for CYP2D6 phenotyping; Drug: Midazolam 2 mg for CYP3A4 phenotyping; Other: Genotyping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic analysis of simvastatin
Population pharmacokinetic modeling and simulation.
Measured: Time 0 up to 24 hours after single dose simvastatin administration.
Pharmacokinetic analysis of carvedilol
Population pharmacokinetic modeling and simulation.
Measured: From time 0 up to 24 hours after single dose carvedilol administration
Secondary outcomes (5)
CYP2D6 phenotyping using metoprolol as a probe drug
The CYP2D6 phenotype was determined by urinary concentration ratio metoprolol/alfa-hydroxymetoprolol.
Measured: Urine sampling collected from time 0 up to 8 hours after metoprolol administration
CYP3A4 phenotyping using midazolam as a probe drug
Midazolam plasma concentration will be determined by chromatographic analysis
Measured: Day 2: a blood sample will be collected after midazolam administration
Genotyping the main SNPs on CYP2C9, CYP2D6, ABCB1 and SLCO1B1 genes
The main SNPs on CYP2C9, CYP2D6, ABCB1 and SLCO1B1 genes will be evaluated by RT-PCR
Measured: Day 1: a blood sample will be collected immediately after your check-in in the clinical research unit
Transcriptomic analysis of liver extracellular vesicles
Expression levels of transporters and enzymes will be quantified by real-time quantitative PCR
Measured: Day 1: a blood sample will be collected immediately after your check-in in the clinical research unit
Transcriptomic analysis of intestine samples
Expression levels of transporters and enzymes will be quantified by real-time quantitative PCR
Measured: Digestive biopsy collected in the second day of research protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2019
- Study start1 Jun 2019
- Primary completionAug 2022 (estimated)
- Study completionAug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Natalia Valadares de Moraes
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo, University of Sao Paulo
- Responsible party
- Sponsor-investigator, Natalia Valadares de Moraes, Universidade Estadual Paulista Júlio de Mesquita Filho
- Investigators
- Wilson Salgado Junior, PhD, Principal investigator, University of Sao PauloJose S dos Santos, PhD, Principal investigator, University of Sao PauloNatalia De Moraes, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04049786
- Sponsor's protocol ID
- RYGB_pk
- Status last verified
- Feb 2022
- First submitted
- 29 Jun 2019
- Last updated
- 8 Feb 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Roux-en-Y Gastric Bypass (RYGB) Bariatric Surgery on System Pharmacology: Single-dose Cross-over Pharmacokinetic Study of Simvastatin and Carvedilol.
- ClinicalTrials.gov ID
- NCT04049786
- Acronym / sponsor ID
- RYGB_pk
- Conditions
- Obesity, Bariatric Surgery, Roux-en Y Gastric Bypass
- Keywords
- Bariatric surgery, Pharmacokinetics, RYGB, CYP2D6, CYP3A4
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Natalia Valadares de MoraesUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo, University of Sao Paulo
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 8 Aug 2019 (actual)
- 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.
Obesity affects more than 1 in 3 adults in the U.S. It is commonly associated with reduced quality of life and complications such as metabolic syndrome, heart disease, high blood pressure and sleep disorders. The gastric bypass, also known as Roux-en-Y gastric bypass (RYGB), is one of the most common weight-loss surgeries due to the reliable and long-lasting weight loss and the effective remission of obesity-associated conditions. Although the impact of obesity on absorption, distribution, metabolism and excretion has been documented for several drugs, label recommendations might not account for specific population subgroups, specially morbidly obese patients and obese patients post-bariatric surgery. This study aims to investigate the impact of obesity and RYGB surgery on the kinetic disposition of simvastatin (Study A) and carvedilol (Study B).
Detailed description
The study is ongoing and eligible subjects are enrolled after signing a written informed consent. Research participants (n=120, in total) include healthy volunteers [body mass index (BMI) ≤ 25 kg/m2], obese [BMI > 30 kg/m2] and patients that underwent RYGB surgery 6-60 month prior this research protocol. On day 1, participants receive a single oral dose of 40 mg simvastatin (Study A) or 25 mg racemic carvedilol (Study B). Serial blood samples are collected up to 24 h for the pharmacokinetic analysis. Blood tests (blood count, fasting blood glucose, lipid profile, serum creatinine, urea, gamma-glutamyl transferase, aspartate aminotransferase and alanine amino transferase) are being monitored for all enrolled participants. Blood samples are also collected for genotyping the main genetic polymorphisms associated with carvedilol or simvastatin pharmacokinetics. Metoprolol is being used as a probe drug for CYP2D6 in vivo phenotyping only for research participants enrolled in Study B. After oral administration of metoprolol (on day 2), urine samples are being collected up to 8h after drug administration to determine the urinary metabolic ratio α-hydroxy metoprolol/metoprolol. As part of the pre-surgery evaluation (obese group) or post-surgery follow-up (RYGB group), obese patients and patients post-RYGB are submitted to digestive endoscopies. Healthy participants will not undergo endoscopic examination. The preparation protocol for digestive endoscopy includes: a) 8-hour fasting; b) 10% spray lidocaine (topical); c) oral simethicone (75 mg/ml, 80 drops); d) oxygen therapy depending on the patient (nasal catheter with O2 at 3 L/min); e) 0.02 to 0.03 mg/kg intravenous midazolam; f) 50 mg pethidine. A blood sample is collected 4-h after intravenous midazolam for in vivo CYP3A4 phenotyping. During the endoscopies, duodenum and jejunum biopsies are being collected to investigated interindividual variability related to drug oral bioavailability (only obese and post-RYGB research participants). Samples collected from digestive biopsies will be used to develop individual enteroid microfluidic systems. In vivo phenotyping of drug metabolizing enzymes and transporters will also be assessed by transcriptome using blood samples. The generated in vitro and in vivo data will be combined to build up physiologically based pharmacokinetic models for precision dosing in obese and post-RYGB patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Simvastatin - Healthy volunteers | Active comparator | Procedure: Serial blood sampling for PK analysis, Drug: Metoprolol 100 mg for CYP2D6 phenotyping, Drug: Simvastatin 40mg, Drug: Midazolam 2 mg for CYP3A4 phenotyping, Other: GenotypingAdult patients (18-65 years old) with body mass index < 25 kg/mˆ2 treated with a single oral dose of 40 mg simvastatin for Pk analysis. Blood samples collected for blood tests, genomics and transcriptomic analysis |
| Carvedilol Study - Healthy volunteers | Active comparator | Drug: Carvedilol 25mg, Procedure: Serial blood sampling for PK analysis, Drug: Metoprolol 100 mg for CYP2D6 phenotyping, Drug: Midazolam 2 mg for CYP3A4 phenotyping, Other: GenotypingAdult patients (18-65 years old) with body mass index < 25 kg/mˆ2 treated with a single oral dose of 25 mg carvedilol for Pk analysis. Blood samples collected for blood tests, genomics and transcriptomic analysis |
| Simvastatin - Obese | Active comparator | Procedure: Digestive biopsy, Procedure: Serial blood sampling for PK analysis, Drug: Metoprolol 100 mg for CYP2D6 phenotyping, Drug: Simvastatin 40mg, Drug: Midazolam 2 mg for CYP3A4 phenotyping, Other: GenotypingAdult patients (18-65 years old) with body mass index > 30 kg/mˆ2 treated with a single oral dose of 40 mg simvastatin for Pk analysis. Blood samples collected for blood tests, genomics and transcriptomic analysis. |
| Carvedilol study - Obese | Active comparator | Procedure: Digestive biopsy, Drug: Carvedilol 25mg, Procedure: Serial blood sampling for PK analysis, Drug: Metoprolol 100 mg for CYP2D6 phenotyping, Drug: Midazolam 2 mg for CYP3A4 phenotyping, Other: GenotypingAdult patients (18-65 years old) with body mass index > 30 kg/mˆ2 treated with a single oral dose of 25 mg carvedilol for Pk analysis. Blood samples collected for blood tests, genomics and transcriptomic analysis. |
| Simvastatin - Post-RYGB | Active comparator | Procedure: Digestive biopsy, Procedure: Serial blood sampling for PK analysis, Drug: Metoprolol 100 mg for CYP2D6 phenotyping, Drug: Simvastatin 40mg, Drug: Midazolam 2 mg for CYP3A4 phenotyping, Other: GenotypingAdult patients (18-65 years old) previously submitted to RYGB surgery treated with a single oral dose of 40 mg simvastatin for Pk analysis. Blood samples collected for blood tests, genomics and transcriptomic analysis. |
| Carvedilol - Post-RYGB | Active comparator | Procedure: Digestive biopsy, Drug: Carvedilol 25mg, Procedure: Serial blood sampling for PK analysis, Drug: Metoprolol 100 mg for CYP2D6 phenotyping, Drug: Midazolam 2 mg for CYP3A4 phenotyping, Other: GenotypingAdult patients (18-65 years old) previously submitted to RYGB surgery treated with a single oral dose of 25 mg carvedilol for Pk analysis. Blood samples collected for blood tests, genomics and transcriptomic analysis. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients of both gender with 18 to 65 years old.
- Healthy volunteers group: body mass index lower or equal to 35 kg/mˆ2.
- Obese group: body mass index higher than 30 kg/mˆ2.
- Post-RYGB group: patients previously submitted to Roux-en-Y gastric bypass bariatric surgery (6-48 months before the study).
Key exclusion criteria (9 listed)
- Pregnant and lactating patients.
- Patients with serum creatinine higher than 1,5 mg/dL.
- Patients with previous altered coagulation.
- Patients with previous cancer history (on the last year).
- Patients with previous hypersensitivity history to simvastatin or carvedilol.
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 |
|---|---|---|
| Digestive biopsyAll patients with indication for RYGB bariatric surgery undergo to endoscopy before and after the surgery as standard protocol. Digestive biopsy are being performed in obese and post-RYGB patients for transcriptomic analysis | Procedure or surgery | Carvedilol - Post-RYGB, Carvedilol study - Obese, Simvastatin - Obese, Simvastatin - Post-RYGB |
| Carvedilol 25mgSingle-dose of carvedilol 25 mg are being administrated orally. | Drug | Carvedilol - Post-RYGB, Carvedilol Study - Healthy volunteers, Carvedilol study - Obese |
| Serial blood sampling for PK analysisSerial blood samples are being collected at times 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18 and 24 hours after drug administration for PK evaluation . | Procedure or surgery | Carvedilol - Post-RYGB, Carvedilol Study - Healthy volunteers, Carvedilol study - Obese, Simvastatin - Healthy volunteers, Simvastatin - Obese, Simvastatin - Post-RYGB |
| Metoprolol 100 mg for CYP2D6 phenotypingMetoprolol is being used as probe drug to evaluate CYP2D6 activity. Single-dose of metoprolol 100 mg are being administrated orally. | Drug | Carvedilol - Post-RYGB, Carvedilol Study - Healthy volunteers, Carvedilol study - Obese, Simvastatin - Healthy volunteers, Simvastatin - Obese, Simvastatin - Post-RYGB |
| Simvastatin 40mgAlso: SVASingle-dose of simvastatin 40 mg are being administrated orally. | Drug | Simvastatin - Healthy volunteers, Simvastatin - Obese, Simvastatin - Post-RYGB |
| Midazolam 2 mg for CYP3A4 phenotypingAlso: MDZMidazolam is being used as probe drug to evaluate CYP3A4 activity. Single-dose of midazolam 2 mg are being administrated intravenous. | Drug | Carvedilol - Post-RYGB, Carvedilol Study - Healthy volunteers, Carvedilol study - Obese, Simvastatin - Healthy volunteers, Simvastatin - Obese, Simvastatin - Post-RYGB |
| GenotypingPatients are being genotyped for the main SNP on CYP2C9, ABCB1, SLCO1B1 and CYP2D6 genes using blood samples | Other | Carvedilol - Post-RYGB, Carvedilol Study - Healthy volunteers, Carvedilol study - Obese, Simvastatin - Healthy volunteers, Simvastatin - Obese, Simvastatin - Post-RYGB |
Primary outcome
Pharmacokinetic analysis of simvastatin
Time frame: Time 0 up to 24 hours after single dose simvastatin administration.
Population pharmacokinetic modeling and simulation.
Pharmacokinetic analysis of carvedilol
Time frame: From time 0 up to 24 hours after single dose carvedilol administration
Population pharmacokinetic modeling and simulation.
5 secondary outcomes
CYP2D6 phenotyping using metoprolol as a probe drug
Time frame: Urine sampling collected from time 0 up to 8 hours after metoprolol administration
CYP3A4 phenotyping using midazolam as a probe drug
Time frame: Day 2: a blood sample will be collected after midazolam administration
Genotyping the main SNPs on CYP2C9, CYP2D6, ABCB1 and SLCO1B1 genes
Time frame: Day 1: a blood sample will be collected immediately after your check-in in the clinical research unit
Transcriptomic analysis of liver extracellular vesicles
Time frame: Day 1: a blood sample will be collected immediately after your check-in in the clinical research unit
Transcriptomic analysis of intestine samples
Time frame: Digestive biopsy collected in the second day of research protocol
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2022.
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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.
Wilson Salgado Junior, PhD principal investigator
University of Sao Paulo
Jose S dos Santos, PhD principal investigator
University of Sao Paulo
Natalia De Moraes, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Digestive biopsy, Carvedilol 25mg and Serial blood sampling for PK analysis in people with Obesity and Bariatric Surgery, run by Natalia Valadares de Moraes at 1 site in United States.
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 4 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 8 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
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?
Pharmacokinetic analysis of simvastatin (time frame: Time 0 up to 24 hours after single dose simvastatin administration.). The study lists 2 primary outcomes in all. 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 8 Feb 2022.