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

Study Overview
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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

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: BLU-5937 IR
* Drug: BLU-5937 ER


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Immediate Release formulation<br>IR Formulation | Drug: BLU-5937 IR<br>* Each subject will receive two single and multiple administrations of Immediate Release reference formulation<br>|
| Experimental: Extended Release formulation<br>ER formulation | Drug: BLU-5937 ER<br>* Each subject will receive single and multiple oral administrations of Extended Release formulation<br>|

What is the study measuring?
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Primary Outcome Measures

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