CoughPhase 1NCT05570539
Assessment of the Pharmacokinetics of BLU-5937 Extended Release Prototypes and a BLU-5937 Immediate Release Reference Formulation
A Phase 1 study testing BLU-5937 IR and BLU-5937 ER in people with Cough and Healthy, run by Bellus Health Inc. - a GSK company at 1 site in United Kingdom.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- What is being tested?
- BLU-5937 IR and BLU-5937 ER
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 Oct 2022to 1 Jul 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males or non-pregnant, non-lactating healthy females
Who cannot join
- History of clinically significant cardiovascular, renal, hepatic, metabolic, dermatological, respiratory, GI, neurological, endocrine, haematological, immunological or psychiatric disorder, as judged by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- BLU-5937 IR, BLU-5937 ER
- Medical subject headings
- Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BLU-5937 IRDrug
Each subject will receive two single and multiple administrations of Immediate Release reference formulation
BLU-5937 ERDrug
Each subject will receive single and multiple oral administrations of Extended Release formulation
| Study group | Role | What they receive |
|---|---|---|
| Immediate Release formulation | Active comparator | IR Formulation Receives: Drug: BLU-5937 IR |
| Extended Release formulation | Experimental | ER formulation Receives: Drug: BLU-5937 ER |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2022
- Study start7 Oct 2022
- Primary completion2 May 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoughStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bellus Health Inc. - a GSK company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05570539
- Sponsor's protocol ID
- 222418
- Other IDs
- BUS-P1-09
- Status last verified
- May 2025
- First submitted
- 3 Oct 2022
- Last updated
- 18 May 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05570539
- Acronym / sponsor ID
- 222418
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Bellus Health Inc. - a GSK companyIndustry (pharma, biotech, devices)
- Study start
- 7 Oct 2022 (actual)
- Primary completion
- 2 May 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 6 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate Release formulation | Active comparator | Drug: BLU-5937 IRIR Formulation |
| Extended Release formulation | Experimental | Drug: BLU-5937 ERER formulation |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy males or non-pregnant, non-lactating healthy females
Key exclusion criteria (1 listed)
- History of clinically significant cardiovascular, renal, hepatic, metabolic, dermatological, respiratory, GI, neurological, endocrine, haematological, immunological or psychiatric disorder, as judged by the investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BLU-5937 IREach subject will receive two single and multiple administrations of Immediate Release reference formulation | Drug | Immediate Release formulation |
| BLU-5937 EREach subject will receive single and multiple oral administrations of Extended Release formulation | Drug | Extended Release formulation |
Primary outcome
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 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 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BLU-5937 IR and BLU-5937 ER in people with Cough and Healthy, run by Bellus Health Inc. - a GSK company at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of the maximum observed plasma drug concentration (Cmax) (time frame: Pre dose up to 36 hours post-dose). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2025.