A Phase 1 interventional study of BLU-5937 in Healthy, sponsored by Bellus Health Inc. - a GSK company. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-22.
Sponsored by Bellus Health Inc. - a GSK company (part of GlaxoSmithKline) · Phase 1, Interventional, and Treatment
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
Bellus Health Inc. - a GSK company is the lead sponsor of 19 studies on the registry; none are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 4 (36%) have results posted.
First submitted after Bellus Health Inc. became part of GlaxoSmithKline.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
10 Japanese and 8 Caucasian subjects. 8 out of 10 Japanese subjects will receive BLU-5937 Dose A and 2 will receive placebo. All Caucasian subjects will receive BLU-5937 Dose A.
Drug: BLU-5937
8 Japanese subjects. 6 out of 8 will receive BLU-5937 Dose B and 2 will receive placebo.
Drug: BLU-5937
8 Japanese subjects. 6 out of 8 will receive BLU-5937 Dose C and 2 will receive placebo.
Drug: BLU-5937
Single and multiple doses assessment
Assessment of ECG QTcF interval (ms) change
Time frame: Pre-dose up to 48 hours post-dose for both single and multiple administration
Assessment of diastolic and systolic blood pressure (mmHg) change
Time frame: Pre-dose up to 48 hours post-dose for both single and multiple administration
Assessment of heart rate (BPM) change
Time frame: Pre-dose up to 48 hours post-dose for both single and multiple administration
Number of participants with clinically significant changes in Clinical laboratory tests
Time frame: Pre-dose up to 48 hours post-dose for both single and multiple administration
Number of participants with clinically significant changes in Physical Examination
Time frame: Pre-dose up to 48 hours post-dose for both single and multiple administration
Adverse Event and Adverse Event of medical interest monitoring
Time frame: Pre-dose up to 48 hours post-dose for both single and multiple administration and again at follow-up call (1 week after discharge)
Measurement of the area under the plasma concentration by time curve (AUC)
Time frame: Pre-dose up to 48 hours post-dose for both single and multiple administration
Measurement of the maximum observed plasma drug concentration (Cmax)
Time frame: Pre-dose up to 48 hours post-dose for both single and multiple administration
Plan to share: No
No publications or documents are linked to this record.
Ran from Aug 2021 to primary completion in Oct 2021, 2 months.
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This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: BLU-5937
Bellus Health Inc. - a GSK company →