NCT06301529

The Efficacy and Tolerability of Canagliflozin in Healthy Individual

The Efficacy and Tolerability of Canagliflozin in Healthy Individuals Comparing Dosing Protocols of Canagliflozin for Use as a Gerotherapeutic

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: AgelessRx · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

Summary

The primary objective is to measure the effects that canagliflozin intervention has on reducing average glucose in healthy individuals. The secondary objective is to assess the tolerability and side effects and urinary glucose excretion following the pulsatile dosing protocol.

Detailed description

This study is designed to mitigate the effects of glucose with intermittent oral Canagliflozin for healthy, non-diabetic volunteers of any sex who enroll in the study. Participants will provide informed consent via AgelessRx electronic medical record. If eligible, prescriptions will be provided online through the AgelessRx website (www.agelessrx.com). Participants will be randomized into two arms: Arm A will take 100 mg of canagliflozin each day for a total of 7 doses, while Arm B will take 150 mg of canagliflozin every other day for a total of 4 doses. Participants in Arm B will also be provided a pill cutter to use throughout the trial on the 300mg tablet. All participants will begin the trial on the day that they apply a continuous glucose monitor (considered Day 0) and will be asked to take daily blood pressure reading. After one week of baseline readings, both arms will start their canagliflozin dosing protocols. Participants will be asked to complete 7 total surveys to outline side effects and tolerability, one each day starting after their canagliflozin consumption. Participants will be asked to complete a dietary intake journal through Day 0 -Day 14. Lifesum (https://lifesum.com/) should be used to track Carbohydrate/Protein/Fat consumption. Participants will share their dietary intake journal twice over their participation (Day 7 \& Day 14).

Conditions

• Healthy Aging

Interventions

Type	Name	Description
DRUG	Invokana Pill	100 mg and 150 mg doses, taken every day and every-other day, respectively.

Timeline

• Start date: 2024-02-12
• Primary completion: 2024-06-29
• Completion: 2024-06-29
• First posted: 2024-03-08
• Last updated: 2024-07-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study