Assessment of the Pharmacokinetics of BLU-5937 Extended Release Prototypes and a BLU-5937 Immediate Release Reference Formulation

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05570539

Enrollment

Registered

2022-10-06

Start date

2022-10-07

Completion date

2024-07-01

Last updated

2025-05-18

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

Conditions

Cough, Healthy

Brief 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

Interventions

DRUGBLU-5937 IR

Each subject will receive two single and multiple administrations of Immediate Release reference formulation

DRUGBLU-5937 ER

Each subject will receive single and multiple oral administrations of Extended Release formulation

Study design

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Measurement of the maximum observed plasma drug concentration (Cmax)	Pre dose up to 36 hours post-dose	To assess the comparison between Cmax following administration of an Extended Release tablet formulation and an Immediate Release reference formulation.
Measurement of the minimum observed plasma drug concentration (Cmin)	Pre dose up to 36 hours post-dose	To assess the comparison between Cmin following administration of an Extended Release tablet formulation and an Immediate Release reference formulation.
Measurement of the area under the plasma drug concentration by time curve AUC	Pre dose up to 36 hours post-dose	To assess the comparison between AUC following administration of an Extended Release tablet formulation and an Immediate Release reference formulation.
Measurement of the observed plasma drug concentration 24 hours post-dose (C24)	24 hours post-dose	To assess the comparison between C24 following administration of an Extended Release tablet formulation and an Immediate Release reference formulation.

Countries

United Kingdom

Outcome results

None listed

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