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

Phase 1

Completed

• Conditions: Healthy; Cough
• Interventions: Drug: BLU-5937 IR; Drug: BLU-5937 ER

• Registration Number: NCT05570539
• Lead Sponsor: Bellus Health Inc. - a GSK company

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-03
• Study First Submitted QC: 2022-10-04
• Study First Posted: 2022-10-06
• Study Start: 2022-10-07
• Primary Completion: 2024-05-02
• Study Completion: 2024-07-01
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-16
• Last Update Posted: 2025-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Healthy males or non-pregnant, non-lactating healthy females

Exclusion Criteria

• History of clinically significant cardiovascular, renal, hepatic, metabolic, dermatological, respiratory, GI, neurological, endocrine, haematological, immunological or psychiatric disorder, as judged by the investigator.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Immediate Release formulation	BLU-5937 IR	IR Formulation
Extended Release formulation	BLU-5937 ER	ER formulation

Primary Outcome Measures

Name	Time	Method
Measurement of the minimum observed plasma drug concentration (Cmin)	Pre dose up to 36 hours post-dose	To assess the comparison between Cmin following administration of an Extended Release tablet formulation and an Immediate Release reference formulation.
Measurement of the maximum observed plasma drug concentration (Cmax)	Pre dose up to 36 hours post-dose	To assess the comparison between Cmax following administration of an Extended Release tablet formulation and an Immediate Release reference formulation.
Measurement of the area under the plasma drug concentration by time curve AUC	Pre dose up to 36 hours post-dose	To assess the comparison between AUC following administration of an Extended Release tablet formulation and an Immediate Release reference formulation.
Measurement of the observed plasma drug concentration 24 hours post-dose (C24)	24 hours post-dose	To assess the comparison between C24 following administration of an Extended Release tablet formulation and an Immediate Release reference formulation.

Trial Locations

Locations (1)

GSK Investigational Site; 🇬🇧 Nottingham, United Kingdom