NCT06556745

Pharmacokinetics of Butyrate Tablet BKR-017

A Phase 1 Study of Safety and Pharmacokinetics of BKR-017 in Individuals on Statin Therapy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 9 (actual)
• Sponsor: BioKier Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: —

Summary

The purpose of this study is to evaluate the pharmacokinetic profile and systemic exposure of BKR-017 in individuals on statin therapy after a single dose and at steady state after seven days repeated twice daily dosing.

Detailed description

BioKier will conduct an open-label study to evaluate the safety and PK profile of BKR-017 in ten hypercholesterolemic (\>100 mg/dL) statin-treated subjects (to reflect the target population), aged 18-70, after a single dose and at steady-state after seven days repeat dosing. On the morning of Study Day 0, subjects will take three tablets (1.5 g of BKR-017), followed by breakfast. Blood samples will be taken for PK analysis at -1, -0.25, 1, 2, 4, 6, 8, 10, 12, and 24 hours after dosing. After an overnight stay in the clinic, the 24-hour PK sample will be taken, and subjects will be provided with one week's supply of BKR-017 tablets and a diary for keeping track of tablets taken, instructed to take three 500-mg tablets (1.5 g) BID, and released from the clinic. On Study Day 8, subjects will return to the clinic, and Study Day 0 procedures will be repeated after dose-compliance is confirmed. PK samples will be analyzed.

Conditions

• Hypercholesterolemia

Interventions

Type	Name	Description
DRUG	BKR-017	BKR-017 is an oral tablet formulation designed to target delivery of sodium butyrate to the colon via colon-targeting technology.

Timeline

• Start date: 2025-07-16
• Primary completion: 2025-12-23
• Completion: 2026-01-15
• First posted: 2024-08-16
• Last updated: 2026-04-07

Locations

1 site across 1 country: United States