Clinical Trials Logo
  1. Home
  2. Healthy
  3. NCT05570539
  4. Details
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
See also
  Status Clinical Trial Phase
Recruiting NCT06052553 - A Study of TopSpin360 Training Device N/A
Completed NCT05511077 - Biomarkers of Oat Product Intake: The BiOAT Marker Study N/A
Recruiting NCT04632485 - Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
Completed NCT05931237 - Cranberry Flavan-3-ols Consumption and Gut Microbiota in Healthy Adults N/A
Completed NCT04527718 - Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers Phase 1
Terminated NCT04556032 - Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women N/A
Completed NCT04998695 - Health Effects of Consuming Olive Pomace Oil N/A
Completed NCT04065295 - A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225 Phase 1
Completed NCT04107441 - AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects Phase 1
Completed NCT01442831 - Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects Phase 1
Terminated NCT05934942 - A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood Phase 1
Recruiting NCT05525845 - Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI N/A
Completed NCT05515328 - A Study in Healthy Men to Test How BI 685509 is Processed in the Body Phase 1
Completed NCT04967157 - Cognitive Effects of Citicoline on Attention in Healthy Men and Women N/A
Completed NCT05030857 - Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects Phase 1
Recruiting NCT04714294 - Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers Phase 1
Recruiting NCT04494269 - A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls Phase 1
Completed NCT04539756 - Writing Activities and Emotions N/A
Recruiting NCT04098510 - Concentration of MitoQ in Human Skeletal Muscle N/A
Completed NCT03308110 - Bioavailability and Food Effect Study of Two Formulations of PF-06650833 Phase 1