A Study to Assess the Effects of Canagliflozin (JNJ-28431754) on the Pharmacokinetics, Pharmacodynamics, and Safety of Simvastatin in Healthy Volunteers

NCT01821027 | Completed Phase 1

• 2 other identifiers: CR01551128431754DIA1009
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine how multiple doses of canagliflozin (JNJ-28431754) affect the pharmacokinetics (ie, how the body affects the drug) and pharmacodynamics (ie, how the drug affects the body) of a single dose of simvastatin.

Conditions

Healthy

Keywords

Healthy; Canagliflozin (JNJ-28431754); Pharmacokinetics; Pharmacodynamics; Simvastatin (ZOCOR)

Outcome Measures

Primary Outcomes (3)

• Plasma concentrations of simvastatin

  Comparison of plasma concentrations of simvastatin following administration of a single dose of simvastatin alone or in combination with multiple doses of canagliflozin (JNJ-28431754). This will be used to determine whether there is a pharmacokinetic interaction between simvastatin and canagliflozin.

  Up to Day 8

• Plasma concentrations of the active beta-hydroxyacid metabolite of simvastatin

  Comparison of plasma concentrations of the active metabolite of simvastatin following administration of a single dose of simvastatin alone or in combination with multiple doses of canagliflozin (JNJ-28431754). This will be used to determine whether there is a pharmacokinetic interaction between simvastatin and canagliflozin.

  Up to Day 8

• Plasma concentrations of active 3-hydroxy-3-methyl-glutaryl-coenzyme A (HMG-CoA) reductase inhibitory activity

  Comparison of plasma HMG-CoA reductase inhibitory activity following administration of a single dose of simvastatin alone or in combination with multiple doses of canagliflozin (JNJ-28431754). This will be used to determine whether there is a pharmacodynamic interaction between simvastatin and canagliflozin. (Simvastatin lowers cholesterol by inhibiting the activity of the enzyme HMG-CoA reductase).

  Up to Day 8

Study Arms (1)

Canagliflozin + simvastatin

EXPERIMENTAL

Each volunteer will receive a single dose of simvastatin on Day 1, followed by canagliflozin (JNJ-28431754) once daily on Days 2 through 6. On Day 7 volunteers will receive a single dose of simvastatin in combination with a single dose of canagliflozin.

Drug: Simvastatin; Drug: Canagliflozin (JNJ-28431754)

Interventions

Simvastatin DRUG

One 40 mg tablet taken orally (by mouth) on Day 1 and Day 7.

Also known as: Zocor

Canagliflozin + simvastatin

Canagliflozin (JNJ-28431754) DRUG

One 300 mg dose (ie, one 100 mg and one 200 mg over-encapsulated tablet) taken orally (by mouth) on Days 2 through Day 7.

Also known as: JNJ-28431754

Canagliflozin + simvastatin

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Volunteers must have a body mass index (BMI) (weight in kg/height in m2) between 18 and 30 kg/m2 (inclusive), and body weight not less than 50 kg
• Volunteers must be non-smokers

You may not qualify if:

• \- History of, or current active illness, considered to be clinically significant by the Investigator, or any other illness that the Investigator considers should exclude the patient from the study, or that could interfere with the interpretation of the study results

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead

Related Publications (1)

• Devineni D, Manitpisitkul P, Murphy J, Skee D, Wajs E, Mamidi RN, Tian H, Vandebosch A, Wang SS, Verhaeghe T, Stieltjes H, Usiskin K. Effect of canagliflozin on the pharmacokinetics of glyburide, metformin, and simvastatin in healthy participants. Clin Pharmacol Drug Dev. 2015 May-Jun;4(3):226-36. doi: 10.1002/cpdd.166. Epub 2014 Oct 27.

  PMID: 27140803 DERIVED

MeSH Terms

Interventions

Simvastatin; Canagliflozin

Intervention Hierarchy (Ancestors)

Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Thiophenes; Sulfur Compounds; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glucosides; Glycosides; Carbohydrates

Study Officials

• Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

  Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2013
• First Posted: March 29, 2013
• Study Start: August 1, 2008
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: March 29, 2013

Record last verified: 2013-03