Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Canagliflozin once daily and HCTZ once daily · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| 001 | EXPERIMENTAL | Canagliflozin 300 mg once daily and HCTZ 25 mg once daily Period 1: canagliflozin tablets oral 300 mg once daily on Days 1 to 7 followed 14 days later by Period 2. Period 2: HCTZ tablets oral 25 mg once daily for Days 1 to 28 followed by canagliflozin tablets oral 300 mg once daily taken with HCTZ tablets oral 25 mg once daily on Days 29 to 35.. |
| 002 | EXPERIMENTAL | Canagliflozin 100 mg once daily and 50 mg twice daily Treatment C (one 100-mg tablet once daily for 5 days) followed 10 days later by Treatment D (one 50-mg tablet twice daily for 5 days) or Treatment D followed by Treatment C. |
| Name | Type | Description |
|---|---|---|
| Canagliflozin 300 mg once daily and HCTZ 25 mg once daily | DRUG | Period 1: canagliflozin tablets, oral, 300 mg, once daily on Days 1 to 7 followed 14 days later by Period 2. Period 2: HCTZ tablets, oral, 25 mg, once daily for Days 1 to 28 followed by canagliflozin tablets, oral, 300 mg, once daily taken with HCTZ tablets, oral 25 mg, once daily on Days 29 to 35.. |
| Canagliflozin 300 mg once daily and 150 mg twice daily | DRUG | Treatment A (one 300-mg tablet once daily for 5 days) followed 10 days later by Treatment B (one 50-mg and one 100-mg tablet twice daily for 5 days) or Treatment B followed by Treatment A. |
| Canagliflozin 100 mg once daily and 50 mg twice daily | DRUG | Treatment C (one 100-mg tablet once daily for 5 days) followed 10 days later by Treatment D (one 50-mg tablet twice daily for 5 days) or Treatment D followed by Treatment C. |
Inclusion Criteria: * Healthy volunteers with a body mass index (BMI, a measure of a person's weight in relation to height) between 18 and 30 kg/m2, inclusive, and a body weight of not less than 50 kg Exclusion Criteria: * History of or current clinically significant medical illness as determined...
Canagliflozin once daily and HCTZ once daily is a combination treatment pairing canagliflozin, an SLC5A2 inhibitor, with hydrochlorothiazide (HCTZ), a diuretic. It has been studied in Phase 1 clinical trials in healthy adult volunteers, evaluating pharmacodynamics, pharmacokinetics, and safety. The specific indication pursued in these studies is undisclosed.
Canagliflozin targets SLC5A2, also known as sodium-glucose cotransporter 2, and acts as an inhibitor of that transporter. HCTZ is a thiazide diuretic. The combination pairs SLC5A2 inhibition with diuretic activity, and the two Phase 1 studies examined the pharmacodynamic and pharmacokinetic interaction between the two agents in healthy volunteers.
Johnson & Johnson, which trades under the ticker JNJ, is the developer of the canagliflozin once daily and HCTZ once daily combination. The company sponsored the Phase 1 studies of the pairing in healthy adult volunteers.
Canagliflozin once daily and HCTZ once daily is in Phase 1 development. Two Phase 1 trials have been completed, and no trials are currently active. The studies enrolled a combined total of 64 healthy adult volunteers and were randomized and controlled, though not double blind.
Two completed Phase 1 trials studied this combination. NCT01294631 was a pharmacodynamics, pharmacokinetics, and safety study of hydrochlorothiazide and canagliflozin in 30 healthy volunteers. NCT01286103 was a pharmacokinetic and pharmacodynamic study of once-daily and twice-daily canagliflozin dosing in 34 healthy adult volunteers. Both are completed.