Pharmacokinetics of Simvastatin Post Laparoscopic Sleeve Gastrectomy (LSG)

NCT03571802 | Unknown Phase 4 DMC FDA Drug

• 1 other identifier: LSGSIMVASTATIN
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to investigate the change in systemic exposure of simvastatin post LSG.

Conditions

Obesity; Hyperlipidemias

Keywords

pharmacokinetics; simvastatin; bariatric surgery; laparoscopic sleeve gastrectomy

Outcome Measures

Primary Outcomes (6)

• Area Under Curve (AUC) of simvastatin

  Ratio of AUC of simvastatin for each subject before and 3 months after surgery will be calculated, the mean ratio will be reported

  baseline (before surgery). 3 months after surgery

• Maximum serum concentration (Cmax) of simvastatin

  Ratio of Cmax of simvastatin for each subject before and 3 months after surgery will be calculated, the mean ratio will be reported

  baseline (before surgery). 3 months after surgery

• Time at which maximum serum concentration (Tmax) of simvastatin

  Ratio of Tmax of simvastatin for each subject before and 3 months after surgery will be calculated, the mean ratio will be reported

  baseline (before surgery). 3 months after surgery

• Area Under Curve (AUC) of simvastatin acid

  Ratio of AUC of simvastatin acid for each subject before and 3 months after surgery will be calculated, the mean ratio will be reported

  baseline (before surgery). 3 months after surgery

• Maximum serum concentration (Cmax) of simvastatin acid

  Ratio of Cmax of simvastatin acid for each subject before and 3 months after surgery will be calculated, the mean ratio will be reported

  baseline (before surgery). 3 months after surgery

• Time at which maximum serum concentration (Tmax) of simvastatin acid

  Ratio of Tmax of simvastatin acid for each subject before and 3 months after surgery will be calculated, the mean ratio will be reported

  baseline (before surgery). 3 months after surgery

Study Arms (1)

intervention arm

EXPERIMENTAL

simvastatin 20mg once

Drug: Simvastatin

Interventions

Simvastatin DRUG

* The subject will take simvastatin 20mg at 0 h (after stopping simvastatin for 5 days). 5 mL of blood will be sampled at 0 h, 1 h, 2 h, 3 h, 5 h, 7 h. * There will be 2 blood sampling sessions: 1 before and the other 3 months after surgery.

Also known as: Study arm

intervention arm

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Planned for laparoscopic sleeve gastrectomy at National University Hospital
• Taking statin
• Aged 21 or above

You may not qualify if:

• Patient on concomitant treatment with medications/ food/ herbal supplements that may affect the pharmacokinetics of simvastatin: boceprevir, conivaptan, cyclosporine, efavirenz, mitotane, tocilizumab, rifamycin, amiodarone, amlodipine, aprepitant, azithromycin, colchicine, fenofibrate, imatinib, raltegravir, ranolazine, teriflunomide, ticagrelor, fusidic acid, protease inhibitors, telaprevir, telithromycin, gemfibrozil, erythromycin, clarithromycin, carbamazepine, rifampicin, ketoconazole, fluconazole, itraconazole, voriconanzole, diltiazem, verapamil, dexamethasone, prednisolone, phenytoin, ritonavir, indinavir, nelfinavir, bosentan, telithromycin, nefazodone, St John's wort, orlistat, sibutramine and other strong CYP 3A4 inhibitors/ inducers
• Pregnant ladies

Sponsors & Collaborators

• National University Hospital, Singapore: lead

Study Sites (1)

National University Hospital

Singapore, 119228, Singapore

RECRUITING

Related Publications (2)

• Skottheim IB, Stormark K, Christensen H, Jakobsen GS, Hjelmesaeth J, Jenssen T, Reubsaet JL, Sandbu R, Asberg A. Significantly altered systemic exposure to atorvastatin acid following gastric bypass surgery in morbidly obese patients. Clin Pharmacol Ther. 2009 Sep;86(3):311-8. doi: 10.1038/clpt.2009.82. Epub 2009 Jun 3.

  PMID: 19494810 BACKGROUND

• Jakobsen GS, Skottheim IB, Sandbu R, Christensen H, Roislien J, Asberg A, Hjelmesaeth J. Long-term effects of gastric bypass and duodenal switch on systemic exposure of atorvastatin. Surg Endosc. 2013 Jun;27(6):2094-101. doi: 10.1007/s00464-012-2716-3. Epub 2012 Dec 18.

  PMID: 23247745 BACKGROUND

MeSH Terms

Conditions

Obesity; Hyperlipidemias

Interventions

Simvastatin

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Asim Shabbir, MBBS

  National University Hospital, Singapore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Asim Shabbir, MBBS

CONTACT

+65 9820 0814; cfsasim@nuhs.edu.sg

Elaine Lo, PharmD

CONTACT

+65 9877 2682; elaine_lo@nuhs.edu.sg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pharmacokinetic parameters of simvastatin before and after laparoscopic sleeve gastrectomy will be compared in 10 patients. Each patient will serve as their own control for comparison.

Study Record Dates

• First Submitted: May 22, 2018
• First Posted: June 28, 2018
• Study Start: June 13, 2018
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: April 8, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)