Evaluation of the Pharmacokinetics and Safety of BLU-5937 in Healthy Adult Japanese and Caucasian Subjects

Healthy Clinical Trial

Official title:

A Phase I, Double-Blind, Randomised, Adaptive-designed Study to Assess the Pharmacokinetics and Safety of BLU-5937 in Healthy Adult Japanese and Caucasian Subjects Following Single and Multiple Oral Doses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06179537
• Other study ID #: BUS-P1-07
• Status: Completed
• Phase: Phase 1
• Start date: August 6, 2021
• Est. completion date: November 21, 2021

Study information

• Verified date: November 2023
• Source: Bellus Health Inc. - a GSK company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a Phase I, Double-Blind, Randomised, Adaptive-designed Study to Assess the Pharmacokinetics and Safety of BLU-5937 in Healthy Adult Japanese and Caucasian Subjects Following Single and Multiple Oral Doses

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: November 21, 2021
• Est. primary completion date: October 22, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Healthy males or non-pregnant, non-lactating healthy females

Exclusion Criteria:

• History of neurological, endocrine, cardiovascular, respiratory, haematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• BLU-5937
Single and multiple doses assessment

Locations

Country	Name	City	State
United Kingdom	Richmond Pharmacology Ltd.	London

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	Assessment of ECG QTcF interval (ms) change		Pre-dose up to 48 hours post-dose for both single and multiple administration
Primary	Assessment of diastolic and systolic blood pressure (mmHg) change		Pre-dose up to 48 hours post-dose for both single and multiple administration
Primary	Assessment of heart rate (BPM) change		Pre-dose up to 48 hours post-dose for both single and multiple administration
Primary	Number of participants with clinically significant changes in Clinical laboratory tests		Pre-dose up to 48 hours post-dose for both single and multiple administration
Primary	Number of participants with clinically significant changes in Physical Examination		Pre-dose up to 48 hours post-dose for both single and multiple administration
Primary	Adverse Event and Adverse Event of medical interest monitoring		Pre-dose up to 48 hours post-dose for both single and multiple administration and again at follow-up call (1 week after discharge)
Primary	Measurement of the area under the plasma concentration by time curve (AUC)		Pre-dose up to 48 hours post-dose for both single and multiple administration
Primary	Measurement of the maximum observed plasma drug concentration (Cmax)		Pre-dose up to 48 hours post-dose for both single and multiple administration