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
Overview
- Phase
- Phase 1
- Intervention
- BLU-5937 IR
- Conditions
- Cough
- Sponsor
- Bellus Health Inc. - a GSK company
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Measurement of the minimum observed plasma drug concentration (Cmin)
- Status
- Completed
- Last Updated
- 11 months ago
Overview
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
Investigators
Eligibility Criteria
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.
Arms & Interventions
Immediate Release formulation
IR Formulation
Intervention: BLU-5937 IR
Extended Release formulation
ER formulation
Intervention: BLU-5937 ER
Outcomes
Primary Outcomes
Measurement of the minimum observed plasma drug concentration (Cmin)
Time Frame: 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 maximum observed plasma drug concentration (Cmax)
Time Frame: 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 area under the plasma drug concentration by time curve AUC
Time Frame: 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)
Time Frame: 24 hours post-dose
To assess the comparison between C24 following administration of an Extended Release tablet formulation and an Immediate Release reference formulation.