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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06179537

Enrollment

Registered

2023-12-22

Start date

2021-08-06

Completion date

2021-11-21

Last updated

2023-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief 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

Interventions

DRUGBLU-5937

Single and multiple doses assessment

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Assessment of ECG QTcF interval (ms) change	Pre-dose up to 48 hours post-dose for both single and multiple administration
Assessment of diastolic and systolic blood pressure (mmHg) change	Pre-dose up to 48 hours post-dose for both single and multiple administration
Assessment of heart rate (BPM) change	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	Pre-dose up to 48 hours post-dose for both single and multiple administration
Number of participants with clinically significant changes in Physical Examination	Pre-dose up to 48 hours post-dose for both single and multiple administration
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)
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
Measurement of the maximum observed plasma drug concentration (Cmax)	Pre-dose up to 48 hours post-dose for both single and multiple administration

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026