Last updated: 06/27/2025 08:30:21
Assessment of the Pharmacokinetics of BLU-5937 Extended Release Prototypes and a BLU-5937 Immediate Release Reference Formulation
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: 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
Trial description: 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
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Measurement of the maximum observed plasma drug concentration (Cmax)
Timeframe: Pre dose up to 36 hours post-dose
Measurement of the minimum observed plasma drug concentration (Cmin)
Timeframe: Pre dose up to 36 hours post-dose
Measurement of the area under the plasma drug concentration by time curve AUC
Timeframe: Pre dose up to 36 hours post-dose
Measurement of the observed plasma drug concentration 24 hours post-dose (C24)
Timeframe: 24 hours post-dose
Secondary outcomes:
Not applicable
Interventions:
Drug: BLU-5937 IR
Drug: BLU-5937 ER
Enrollment:
30
Observational study model:
Not applicable
Primary completion date:
2024-02-05
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Cough, Healthy
Product
Not applicable
Collaborators
Not applicable
Study date(s)
October 2022 to July 2024
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 55 Years
Accepts healthy volunteers
Yes
- Healthy males or non-pregnant, non-lactating healthy females
- History of clinically significant cardiovascular, renal, hepatic, metabolic, dermatological, respiratory, GI, neurological, endocrine, haematological, immunological or psychiatric disorder, as judged by the investigator.
Inclusion and exclusion 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.
Trial location(s)
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Completed
Actual primary completion date
2024-02-05
Actual study completion date
2024-01-07
Plain language summaries
Summary of results in plain language
Available language(s): English
To view plain language summaries on trialsummaries.com click here.
Additional information about the trial
Additional information
Not applicable
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