Skip to main content
OpenTrials
Completed

NCT Number: NCT06179537

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Richmond Pharmacology Ltd.

London, SE1 1YR, 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 neurological, endocrine, cardiovascular, respiratory, haematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease.

Treatment and study plan

BLU-5937

Drug

Single and multiple doses assessment

Primary outcomes

  1. Assessment of ECG QTcF interval (ms) change

    Time frame: Pre-dose up to 48 hours post-dose for both single and multiple administration

  2. 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

  3. Assessment of heart rate (BPM) change

    Time frame: Pre-dose up to 48 hours post-dose for both single and multiple administration

  4. 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

  5. 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

  6. 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)

  7. 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

  8. 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

Sponsors and collaborators

Lead sponsor

Bellus Health Inc. - a GSK company

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 22, 2023
Registry last updated
Dec 22, 2023

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.