A Study to Assess the Effects of Multiple-Dose Probenecid on the Multiple-Dose Pharmacokinetics of Canagliflozin in Healthy Volunteers

Johnson & Johnson (J&J)

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Canagliflozin/Probenecid

Study type

Interventional

Funder types

Industry

Identifiers

NCT01428284

28431754DIA1048 (Other Identifier)

CR018736

Details and patient eligibility

About

The purpose of this study is to assess the effects of multiple doses of probenecid on the multiple-dose pharmacokinetics of canagliflozin and its metabolites in healthy volunteers. Safety and tolerability will also be assessed.

Full description

This will be a single-center, open-label (identity of study treatments will be known to volunteers participating in the study as well as to study staff) study to assess the effects of multiple doses of probenecid on the multiple-dose pharmacokinetics of canagliflozin and its metabolites in healthy volunteers. The study will last up to approximately 49 days (includes a Screening Phase of up to 19 days, an Open-Label Treatment Phase of 20 days, and a Post-Treatment Phase of up to 7 to 10 days). Healthy volunteers will take orally (by mouth) one 300 mg canagliflozin tablet once daily and/or one 500-mg probenecid tablet twice daily in sequential order as follows: Days 1 to 14 (administration of canagliflozin alone) and Days 15 to 17 (administration of canagliflozin + twice-daily administration of probenecid). On days when both canagliflozin and probenecid are taken, both doses must be taken at approximately the same time.

Enrollment

14 patients

Sex

All

Ages

15 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: Body mass index (BMI) between 18 and 28 kg/m² inclusive and a body weight of not less than 50 kg. Exclusion Criteria:History of or current medical illness, abnormal values for hematology or clinical chemistry laboratory tests, or abnormal physical examination, vital signs or 12-lead electrocardiogram (ECG) deemed to be clinically significant by the Investigator