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

Bellus Health Inc. - a GSK company30 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cough Healthy

Interventions

BLU-5937 IRDRUG

Each subject will receive two single and multiple administrations of Immediate Release reference formulation

BLU-5937 ERDRUG

Each subject will receive single and multiple oral administrations of Extended Release formulation

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

GSK Investigational Site

Nottingham, United Kingdom

Outcomes

Primary Outcomes

Measurement of the maximum observed plasma drug concentration (Cmax)

To assess the comparison between Cmax following administration of an Extended Release tablet formulation and an Immediate Release reference formulation.

Time frame: Pre dose up to 36 hours post-dose

Measurement of the minimum observed plasma drug concentration (Cmin)

To assess the comparison between Cmin following administration of an Extended Release tablet formulation and an Immediate Release reference formulation.

Time frame: Pre dose up to 36 hours post-dose

Measurement of the area under the plasma drug concentration by time curve AUC

To assess the comparison between AUC following administration of an Extended Release tablet formulation and an Immediate Release reference formulation.

Time frame: Pre dose up to 36 hours post-dose

Measurement of the observed plasma drug concentration 24 hours post-dose (C24)

To assess the comparison between C24 following administration of an Extended Release tablet formulation and an Immediate Release reference formulation.

Time frame: 24 hours post-dose

Data from ClinicalTrials.gov

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