CoughPhase 1NCT03638180
BLU-5937: First-in-Human, Single and Multiple Doses Escalation, Safety, Tolerability, Pharmacokinetics and Food Effect
A Phase 1 study testing BLU-5937 in people with Cough, run by Bellus Health Inc. - a GSK company at 1 site in Canada.
Trial summary
This is a first-in-human study that will investigate the safety, tolerability and pharmacokinetics of ascending single and multiple doses of BLU-5937 using a double blind, placebo controlled, randomized, adaptive, single center study design. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Cough
- What is being tested?
- BLU-5937
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteCanada
- Study dates
- 9 Jul 2018to 25 Oct 2018
- 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 adult male and/or female (non-childbearing potential or, for women of childbearing potential, using 2 forms of acceptable birth control or agreed to abide by true abstinence),
- Age: 18 to 55 years (inclusive).
- Body mass index (BMI) : ≥18.5 and ≤30 kg/m².
- Non or ex smoker.
Who cannot join
- Any findings from the medical examination (including medical history, physical examination, vital signs, laboratory tests and ECG) outside from normal and deemed by the investigator to be clinically significant.
- Use of any prescription drugs (with the exception of hormone replacement therapy) in the 28 days prior to the first study drug administration, that in the opinion of the investigator would put into question the status of the volunteer as healthy.
- Volunteers who took an Investigational Product in the 28 days prior to the first study drug administration.
- Volunteers who donated 50 mL or more of blood in the 28 days prior to the first study drug administration.
- Donation of 500 mL or more of blood in the 56 days prior to the first study drug administration.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-Blind, Placebo Controlled, Randomized, Adaptive, First-in-Human Study to Assess, Safety, Tolerability, Pharmacokinetics and Food Effect of Single and Multiple Doses of BLU-5937 Administered Orally in Healthy Male and Female
This is a first-in-human study that will investigate the safety, tolerability and pharmacokinetics of ascending single and multiple doses of BLU-5937 using a double blind, placebo controlled, randomized, adaptive, single center study design. The influence of food on the pharmacokinetics of BLU-5037 will also be investigated.
Read the detailed description
BLU-5937 is a selective P2X3 receptor antagonist being developed for the treatment of chronic cough. This Phase 1 study will investigate the safety, tolerability and pharmacokinetics of ascending single and multiple doses of BLU-5937 administered orally to healthy volunteers.
- Conditions
- Cough
- Being tested
- BLU-5937, Placebo
- Medical subject headings
- Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BLU-5937Drug
BLU-5937 oral tablet
PlaceboDrug
Matching placebo to BLU-5937
| Study group | Role | What they receive |
|---|---|---|
| Single Ascending Doses | Experimental | Single ascending doses, 6 dose levels Receives: Drug: BLU-5937; Drug: Placebo |
| Multiple Ascending Doses | Experimental | Multiple ascending doses, 3 dose levels Receives: Drug: BLU-5937; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and severity of treatment emergent adverse events (TEAEs)
Number and severity of TEAEs collected from dosing until follow up 48 hours after last dose
Measured: up to 48 hours after the last dose
Secondary outcomes (4)
Maximum plasma concentration (Cmax)
To assess Cmax of single and multiple ascending oral doses of BLU-5937
Measured: up to 48 hours after the last dose
Area under the curve (AUC)
To assess AUC of single and multiple ascending oral doses of BLU-5937
Measured: up to 48 hours after the last dose
Maximum plasma concentration (Cmax) under fed conditions
To assess Cmax of a single oral dose of BLU-5937 under fed conditions
Measured: up to 48 hours after the last dose
Area under the curve (AUC) under fed conditions
To assess AUC of a single oral dose of BLU-5937 under fed conditions
Measured: up to 48 hours after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2018
- Study start9 Jul 2018
- Primary completion25 Oct 2018
- Study completion25 Oct 2018
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
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bellus Health Inc. - a GSK company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03638180
- Sponsor's protocol ID
- BUS-P5-703
- Status last verified
- Aug 2018
- First submitted
- 15 Aug 2018
- Last updated
- 9 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo Controlled, Randomized, Adaptive, First-in-Human Study to Assess, Safety, Tolerability, Pharmacokinetics and Food Effect of Single and Multiple Doses of BLU-5937 Administered Orally in Healthy Male and Female
- ClinicalTrials.gov ID
- NCT03638180
- Acronym / sponsor ID
- BUS-P5-703
- Conditions
- Cough
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Bellus Health Inc. - a GSK companyIndustry (pharma, biotech, devices)
- Study start
- 9 Jul 2018 (actual)
- Primary completion
- 25 Oct 2018 (actual)
- Study completion
- 25 Oct 2018 (actual)
- First posted
- 20 Aug 2018 (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 first-in-human study that will investigate the safety, tolerability and pharmacokinetics of ascending single and multiple doses of BLU-5937 using a double blind, placebo controlled, randomized, adaptive, single center study design. The influence of food on the pharmacokinetics of BLU-5037 will also be investigated.
Detailed description
BLU-5937 is a selective P2X3 receptor antagonist being developed for the treatment of chronic cough. This Phase 1 study will investigate the safety, tolerability and pharmacokinetics of ascending single and multiple doses of BLU-5937 administered orally to healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single Ascending Doses | Experimental | Drug: BLU-5937, Drug: PlaceboSingle ascending doses, 6 dose levels |
| Multiple Ascending Doses | Experimental | Drug: BLU-5937, Drug: PlaceboMultiple ascending doses, 3 dose levels |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy adult male and/or female (non-childbearing potential or, for women of childbearing potential, using 2 forms of acceptable birth control or agreed to abide by true abstinence),
- Age: 18 to 55 years (inclusive).
- Body mass index (BMI) : ≥18.5 and ≤30 kg/m².
- Non or ex smoker.
Key exclusion criteria (5 listed)
- Any findings from the medical examination (including medical history, physical examination, vital signs, laboratory tests and ECG) outside from normal and deemed by the investigator to be clinically significant.
- Use of any prescription drugs (with the exception of hormone replacement therapy) in the 28 days prior to the first study drug administration, that in the opinion of the investigator would put into question the status of the volunteer as healthy.
- Volunteers who took an Investigational Product in the 28 days prior to the first study drug administration.
- Volunteers who donated 50 mL or more of blood in the 28 days prior to the first study drug administration.
- Donation of 500 mL or more of blood in the 56 days prior to the first study drug administration.
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-5937BLU-5937 oral tablet | Drug | Multiple Ascending Doses, Single Ascending Doses |
| PlaceboMatching placebo to BLU-5937 | Drug | Multiple Ascending Doses, Single Ascending Doses |
Primary outcome
Number and severity of treatment emergent adverse events (TEAEs)
Time frame: up to 48 hours after the last dose
Number and severity of TEAEs collected from dosing until follow up 48 hours after last dose
4 secondary outcomes
Maximum plasma concentration (Cmax)
Time frame: up to 48 hours after the last dose
Area under the curve (AUC)
Time frame: up to 48 hours after the last dose
Maximum plasma concentration (Cmax) under fed conditions
Time frame: up to 48 hours after the last dose
Area under the curve (AUC) under fed conditions
Time frame: up to 48 hours after the last dose
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 9 Nov 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Cough, run by Bellus Health Inc. - a GSK company at 1 site in Canada.
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 4 inclusion and 5 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 9 Nov 2018. 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 Canada. 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?
Number and severity of treatment emergent adverse events (TEAEs) (time frame: up to 48 hours after the last dose). 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 9 Nov 2018.