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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-07

Study Completion Date

2024-07-01

Brief Summary

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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

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Detailed Description

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Conditions

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Cough Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Immediate Release formulation

IR Formulation

Group Type ACTIVE_COMPARATOR

BLU-5937 IR

Intervention Type DRUG

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

Extended Release formulation

ER formulation

Group Type EXPERIMENTAL

BLU-5937 ER

Intervention Type DRUG

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

Interventions

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BLU-5937 IR

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

Intervention Type DRUG

BLU-5937 ER

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes