NCT05570539

Assessment of the Pharmacokinetics of BLU-5937 Extended Release Prototypes and a BLU-5937 Immediate Release Reference Formulation

A Phase 1, Single-Centre, Open-Label, Two-Part, Sequential Cross-Over Study Designed to Assess the Pharmacokinetic Profile of BLU-5937 Following Administration of Extended Release Formulation Prototypes and an Immediate Release Reference Formulation in Healthy Male and Female Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Bellus Health Inc. - a GSK company · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 1, Single-Centre, Open-Label, Two-Part, Sequential Cross-Over Study Designed to Assess the Pharmacokinetic Profile of BLU-5937 Following Administration of Extended Release Formulation Prototypes and an Immediate Release Reference Formulation in Healthy Male and Female Subjects

Conditions

• Cough
• Healthy

Interventions

Type	Name	Description
DRUG	BLU-5937 IR	Each subject will receive two single and multiple administrations of Immediate Release reference formulation
DRUG	BLU-5937 ER	Each subject will receive single and multiple oral administrations of Extended Release formulation

Timeline

• Start date: 2022-10-07
• Primary completion: 2024-05-02
• Completion: 2024-07-01
• First posted: 2022-10-06
• Last updated: 2025-05-18

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study