CoughPhase 1NCT07684586
A Study to Investigate the Difference In Blood Levels of Camlipixant Between Different Camlipixant Formulation Prototypes
A Phase 1 study testing Camlipixant in people with Cough, run by GlaxoSmithKline at 1 site in United Kingdom.
Trial summary
This is an open-label study being conducted in healthy adults, to learn what happens to the study medicine (camlipixant) they are receiving in a person's body over time (a pharmacokinetic [PK] study). 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?
- Camlipixant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Jul 2026to 27 Aug 2027
- 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
- Participants who are healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, clinical laboratory tests, vital sign measurements, and 12-lead Electrocardiogram (ECG).
- Body weight greater than or equal (>=) 50 kilogram (kg) and body mass index (BMI) within the range 18.5 to 32.0 kilogram per meter square (kg/m^2) (inclusive).
- A female participant is eligible to participate if they are not pregnant or breastfeeding, and one of the following conditions applies:
- Is a participant of non-childbearing potential (PONCBP) as defined in the full protocol.
- OR ii. Is a participant of childbearing potential (POCBP) and using a contraceptive method that is highly effective (with a failure rate of less than [<] 1 percent [%], per year
- Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- Must be willing and able to comply with the protocol.
Who cannot join
- History or presence of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, biliary (including gallstones or previous cholecystectomy), endocrine, hematologic, or neurological disorders capable of significantly altering the absorption, distribution, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data.
- Evidence of current SARS-CoV-2, confirmed by antigen testing, prior to admission in each period.
- Alanine transaminase (ALT) >1.0x Upper limit of normal (ULN)
- Total bilirubin >1.0 x ULN. Participants with Gilbert's syndrome are excluded.
- QT interval corrected for heart rate according to Fridericia's formula (QTcF) >450 millisecond (msec)
- Participants with abnormal 12-lead ECG findings considered clinically significant by the investigator or designee at the screening visit.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
GSK Investigational Site
Nottingham, Nottinghamshire, NG11 6JS
About this study
Official title: A Phase 1 Study to Evaluate the PK and Relative Bioavailability of Different Formulation Prototypes of Camlipixant
This is an open-label study being conducted in healthy adults, to learn what happens to the study medicine (camlipixant) they are receiving in a person's body over time (a pharmacokinetic [PK] study). The goal of the study is to understand how the body processes camlipixant, to check its safety and how well it is tolerated. Participants will receive camlipixant at different dose levels with different formulation types either on an empty stomach or after a meal.
- Conditions
- Cough
- Being tested
- Camlipixant
- Keywords
- Camlipixant, GSK5464714, Cough, Refractory Chronic Cough, Unexplained Chronic Cough, Pharmacokinetics, Safety, Tolerability, Prototypes, Healthy
- Medical subject headings
- Cough, Chronic Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CamlipixantDrug
Also called GSK5464714
Camlipixant will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Sequence 1 | Experimental | Participants will receive camlipixant according to the following sequence: formulation A at dose level 1 (fasted) formulation B at dose level 1 (fasted); formulation C at dose level 2 (fasted); formulation A at dose level 4 (fasted); and formulation A at dose level 1 (fed). Receives: Drug: Camlipixant |
| Treatment Sequence 2 | Experimental | Participants will receive camlipixant according to the following sequence: formulation A at dose level 1 (fasted) formulation B at dose level 1 (fasted); formulation C at dose level 3 (fasted); formulation A at dose level 4 (fasted); and formulation A at dose level 4 (fed). Receives: Drug: Camlipixant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Concentration (Cmax) of Camlipixant
Measured: Pre-dose and up to 48 hours post dose
Area Under the Curve from Zero up to 24 hours [AUC (0-24)] of Camlipixant
Measured: Pre-dose and up to 24 hours post dose
Observed Concentration of Camlipixant at 24 hours (C24)
Measured: 24 hours post dose
Secondary outcomes (3)
Number of Participants Experiencing Adverse Events (AEs)
Measured: Up to 26 Weeks
Number of Participants Experiencing Serious Adverse Events (SAEs)
Measured: Up to 26 Weeks
Number of Participants Experiencing Adverse Event of Special Interest (AESI)
Measured: Up to 26 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start2 Jul 2026
- Primary completion27 Aug 2027 (estimated)
- Study completion27 Aug 2027 (estimated)
Why it stopped: The study has been withdrawn given the recent decision to cease further development of camlipixant in refractory chronic cough (RCC) based on Phase 3 program results.
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.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07684586
- Sponsor's protocol ID
- 223643
- Status last verified
- Aug 2026
- First submitted
- 29 Jun 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.pdf
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Evaluate the PK and Relative Bioavailability of Different Formulation Prototypes of Camlipixant
- ClinicalTrials.gov ID
- NCT07684586
- Acronym / sponsor ID
- 223643
- Conditions
- Cough
- Keywords
- Camlipixant, GSK5464714, Cough, Refractory Chronic Cough, Unexplained Chronic Cough, Pharmacokinetics, Safety, Tolerability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study has been withdrawn given the recent decision to cease further development of camlipixant in refractory chronic cough (RCC) based on Phase 3 program results.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 2 Jul 2026 (actual)
- Primary completion
- 27 Aug 2027 (estimated)
- Study completion
- 27 Aug 2027 (estimated)
- First posted
- 6 Jul 2026 (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 an open-label study being conducted in healthy adults, to learn what happens to the study medicine (camlipixant) they are receiving in a person's body over time (a pharmacokinetic [PK] study). The goal of the study is to understand how the body processes camlipixant, to check its safety and how well it is tolerated. Participants will receive camlipixant at different dose levels with different formulation types either on an empty stomach or after a meal.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Sequence 1 | Experimental | Drug: CamlipixantParticipants will receive camlipixant according to the following sequence: formulation A at dose level 1 (fasted) formulation B at dose level 1 (fasted); formulation C at dose level 2 (fasted); formulation A at dose level 4 (fasted); and formulation A at dose level 1 (fed). |
| Treatment Sequence 2 | Experimental | Drug: CamlipixantParticipants will receive camlipixant according to the following sequence: formulation A at dose level 1 (fasted) formulation B at dose level 1 (fasted); formulation C at dose level 3 (fasted); formulation A at dose level 4 (fasted); and formulation A at dose level 4 (fed). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Participants who are healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, clinical laboratory tests, vital sign measurements, and 12-lead Electrocardiogram (ECG).
- Body weight greater than or equal (>=) 50 kilogram (kg) and body mass index (BMI) within the range 18.5 to 32.0 kilogram per meter square (kg/m^2) (inclusive).
- A female participant is eligible to participate if they are not pregnant or breastfeeding, and one of the following conditions applies:
- OR ii. Is a participant of childbearing potential (POCBP) and using a contraceptive method that is highly effective (with a failure rate of less than [<] 1 percent [%], per year
- Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Key exclusion criteria (6 listed)
- History or presence of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, biliary (including gallstones or previous cholecystectomy), endocrine, hematologic, or neurological disorders capable of significantly altering the absorption, distribution, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data.
- Evidence of current SARS-CoV-2, confirmed by antigen testing, prior to admission in each period.
- Alanine transaminase (ALT) >1.0x Upper limit of normal (ULN)
- Total bilirubin >1.0 x ULN. Participants with Gilbert's syndrome are excluded.
- QT interval corrected for heart rate according to Fridericia's formula (QTcF) >450 millisecond (msec)
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 |
|---|---|---|
| CamlipixantAlso: GSK5464714Camlipixant will be administered. | Drug | Treatment Sequence 1, Treatment Sequence 2 |
Primary outcome
Maximum Observed Concentration (Cmax) of Camlipixant
Time frame: Pre-dose and up to 48 hours post dose
Area Under the Curve from Zero up to 24 hours [AUC (0-24)] of Camlipixant
Time frame: Pre-dose and up to 24 hours post dose
Observed Concentration of Camlipixant at 24 hours (C24)
Time frame: 24 hours post dose
3 secondary outcomes
Number of Participants Experiencing Adverse Events (AEs)
Time frame: Up to 26 Weeks
Number of Participants Experiencing Serious Adverse Events (SAEs)
Time frame: Up to 26 Weeks
Number of Participants Experiencing Adverse Event of Special Interest (AESI)
Time frame: Up to 26 Weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Individual participant dataSharing planned: Yes. Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.pdf
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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 Camlipixant in people with Cough, run by GlaxoSmithKline 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 7 inclusion and 6 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: withdrawn, as of the sponsor's last update on 31 Aug 2026. 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 was withdrawn before enrolling participants, so there are no results.
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?
Maximum Observed Concentration (Cmax) of Camlipixant (time frame: Pre-dose and up to 48 hours post dose). The study lists 3 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 31 Aug 2026.