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NCT05570539 Clinical Trial

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

Healthy Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05570539
Other study ID # 222418
Secondary ID BUS-P1-09
Status Recruiting
Phase Phase 1
First received
Last updated
Start date October 7, 2022
Est. completion date June 28, 2024

Study information
Verified date March 2024
Source Bellus Health Inc. - a GSK company
Contact US GSK Clinical Trials
Phone 877-379-3718
Email GSKClinicalSupportHD@gsk.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Recruiting
Enrollment 32
Est. completion date June 28, 2024
Est. primary completion date June 28, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• BLU-5937 IR
Each subject will receive two single and multiple administrations of Immediate Release reference formulation
• BLU-5937 ER
Each subject will receive single and multiple oral administrations of Extended Release formulation

Locations
Country Name City State
United Kingdom GSK Investigational Site Ruddington Nottinghamshire

Sponsors (1)
Lead Sponsor Collaborator
Bellus Health Inc. - a GSK company

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. Pre dose up to 36 hours post-dose
Primary 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. Pre dose up to 36 hours post-dose
Primary 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. Pre dose up to 36 hours post-dose
Primary 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. 24 hours post-dose
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