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Completed

NCT Number: NCT05570539

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

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

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Key information

Conditions

Cough Healthy Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site

Nottingham, NG11 6JS, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BLU-5937 IR

Drug

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

BLU-5937 ER

Drug

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

Primary outcomes

  1. Measurement of the maximum observed plasma drug concentration (Cmax)

    Time frame: 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.

  2. Measurement of the minimum observed plasma drug concentration (Cmin)

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 24 hours post-dose

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

Sponsors and collaborators

Lead sponsor

Bellus Health Inc. - a GSK company

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Oct 6, 2022
Registry last updated
May 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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