NCT06988423

Evaluation of the Potential Impact of a High-fat Meal on the Pharmacokinetics of CRS3123 in Healthy Adult Participants

A Phase 1, Single-Center, Open-Label, Randomized, Single-Dose, 2-Period, Crossover Study to Evaluate the Potential Impact of High-fat Meal on the Pharmacokinetics of CRS3123 200 mg Capsule in Healthy Adult Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Crestone, Inc · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

Summary

This study will explore the potential effects of high-fat meal on the plasma pharmacokinetics (PK) of CRS3123 when administered as a single oral dose of 200 mg in healthy adult participants.

Detailed description

This study will assess the impact of a high-calorie and high-fat meal on the plasma pharmacokinetics (PK) of CRS3123 in healthy adult participants when administered as a single oral capsule of 200 mg dose. Pharmacokinetics (PK) of a single dose of CRS3123 200 mg will be studied following administration to healthy participants under fed and fasted conditions.

Conditions

• Food Effect in Healthy Participants

Interventions

Type	Name	Description
DRUG	CRS3123 200 mg capsule	CRS3123 200 mg capsule given as a single oral dose

Timeline

• Start date: 2025-04-21
• Primary completion: 2025-06-04
• Completion: 2025-06-04
• First posted: 2025-05-23
• Last updated: 2026-03-18
• Results posted: 2026-03-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study