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

Bellus Health

Status and phase: Completed; Phase 1

Conditions: Healthy; Cough

Treatments: Drug: BLU-5937 IR; Drug: BLU-5937 ER

Study type: Interventional

Funder types: Industry

Identifiers

NCT05570539

BUS-P1-09

222418

Details and patient eligibility

About

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

Enrollment: 30 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Immediate Release formulation

Active Comparator group

Description:

IR Formulation

Treatment:

Drug: BLU-5937 IR

Extended Release formulation

Experimental group

Description:

ER formulation

Treatment:

Drug: BLU-5937 ER