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CoughPhase 1NCT06497517

A Study to Investigate the Effect of Food on Camlipixant Concentrations in Healthy Participants

A Phase 1 study testing GSK5464714- Camlipixant in people with Cough, run by Bellus Health Inc. - a GSK company at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is a single center, single dose, open-label, randomly assigned 2-way crossover study. The study will investigate the food effect on the pharmacokinetics of Camlipixant (GSK5464714) in healthy male and female participants. Eligible participants will be randomized to pre-defined sequences. 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?
GSK5464714- Camlipixant
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
1 siteUnited States
Study dates
9 Jul 2024to 26 Aug 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

  • 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 ECGs including the following:
  • Seated blood pressure (after 5 mins), average of 3 readings, is greater than or equal to (>=) 90/55 millimetre of mercury (mmHg) and less than or equal (<=)140/90 mmHg at the screening visit.
  • Seated heart rate, average of 3 readings, is >= 40 beats per minutes (bpm) and <= 99 bpm at the screening visit.
  • Corrected QT interval using the Fridericia formula (QTcF) on ECG, average of 3 readings, is <= 450 millisecond (msec) and 12-lead ECG findings considered normal or not clinically significant by the investigator or designee at the screening visit.
  • Aspartate transferase (AST), Alanine transaminase (ALT), direct bilirubin, indirect bilirubin, and total bilirubin within normal ranges at the screening visit and check-in. Only abnormal values up to 1.5 x upper limit of normal may be repeated once
  • Continuous non-smoker who has never used nicotine- or tobacco-containing products or light smoker for the last 6 months prior to study screening
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  • Body weight ≥ 50.0 kilogram (kg) and Body mass index (BMI) within the range 18.5 to 32.0 kilogram per meter square (kg/m2) (inclusive) at Screening.
  • Male and female participants must follow protocol-specified contraception guidance.
  • Female participants: A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies
  • Is a woman of nonchildbearing potential (WONCBP)
  • Is a Woman of childbearing potential (WOCBP) and using a contraceptive method that is highly effective
  • A WOCBP must have a negative highly sensitive serum pregnancy test within 24 hours before the first dose of study intervention (i.e., Day -1 of each treatment period)
  • Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the 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, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data.
  • Have a history of malignant neoplasm (excepting definitively treated non melanoma skin cancer or carcinoma in situ of the uterine cervix, which may be enrolled at any time) within the last 5 years.
  • Past or intended use of over-the-counter or prescription medication including herbal medications within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to dosing.
  • Participation in the clinical study would result in loss of blood or blood products in excess of 500 milliliter (mL) within 3 months.
  • Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day.
  • Current enrolment or past participation in another investigational clinical study in which an investigational intervention (e.g., drug, vaccine, invasive device) was administered within the last 30 days or 5.5 half-lives before signing of consent in any other clinical study involving an investigational study intervention or any other type of medical research.
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  • Current enrolment or past participation in this clinical study.
  • Positive pre-study drug/alcohol screen, including tetrahydrocannabinol.
  • Positive Human immunodeficiency virus (HIV) antibody test.
  • Positive coronavirus (severe acute respiratory syndrome coronavirus 2 [SARS-CoV-2]) polymerase chain reaction test at check-in.
  • Presence of Hepatitis B surface antigen (HBsAg) or Hepatitis B core antibody (HBcAb) at screening or within 3 months prior to first dose of study intervention.
  • Positive Hepatitis C virus (HCV) antibody test result at screening or within 3 months prior to starting study intervention.
  • Total bilirubin >1.5x upper limit of normal (ULN), including participants with Gilbert's syndrome.
  • Regular alcohol consumption within 6 months prior to the clinical study defined as: For sites in United States of America (USA), an average weekly intake of 3 units for males or 1.5 units for females.
  • History of known drugs of abuse, including tetrahydrocannabinol, in last 5 years.
  • Sensitivity to heparin or heparin-induced thrombocytopenia.
  • Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the clinical study.
  • Use of any products intended to treat medical conditions that are not approved by the governing health authority in a given country or region (for example, herbal medicine, health supplements, traditional medicine, homeopathic remedies, etc.), within past 30 days prior to signing the consent and during the study.
  • Any dietary restrictions that would prevent the participant from consuming the site menu/meals.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • GSK Investigational Site

    Austin, Texas, 78744

Other trials in United States

About this study

Official title: A Phase 1, Single Center, Single Dose, Open-Label, Randomized, 2-Way Crossover Study to Investigate the Food Effect on the Pharmacokinetics of Camlipixant in Healthy Male and Female Participants

This study is a single center, single dose, open-label, randomly assigned 2-way crossover study. The study will investigate the food effect on the pharmacokinetics of Camlipixant (GSK5464714) in healthy male and female participants. Eligible participants will be randomized to pre-defined sequences. There will be a washout of minimum 7 days between each dose of treatment period.

Conditions
Cough
Being tested
GSK5464714- Camlipixant
Keywords
Camlipixant, GSK5464714-camlipixant, Healthy Participants, Pharmacokinetics, Cross-over Study
Medical subject headings
Cough

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GSK5464714- CamlipixantDrug

    Also called Camlipixant

    GSK5464714- Camlipixant will be administered

Study groups in NCT06497517
Study groupRoleWhat they receive
Sequence 1ExperimentalIn sequence 1, eligible participants will be randomly assigned to 1 of 2 sequences to receive single dose of GSK5464714- Camlipixant on Day 1 under fasting condition (Treatment A), followed by single dose of GSK5464714 in fed condition (Treatment B). There will be a washout period of minimum 7 days between each period.
Receives: Drug: GSK5464714- Camlipixant
Sequence 2ExperimentalIn sequence 2, eligible participants will be randomly assigned to 1 of 2 sequences to receive single dose of GSK5464714- Camlipixant on Day 1 in fed condition (Treatment B), followed by single dose of GSK5464714 under fasting condition (Treatment A). There will be a washout period of minimum 7 days between each period.
Receives: Drug: GSK5464714- Camlipixant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Area Under the Plasma Concentration-Time Curve (AUC) from Time Zero to Infinity Post-Dose [AUC(0-inf)

    Measured: Up to Day 3 for each period

  2. Maximum Observed Plasma Drug Concentration (Cmax)

    Measured: Up to Day 3 for each period

Secondary outcomes (12)

  1. Time to Maximum Observed Plasma Drug Concentration (Tmax)

    Measured: Up to Day 3 for each period

  2. Apparent Terminal Phase Half-Life (t½)

    Measured: Up to Day 3 for each period

  3. Apparent Oral Clearance (CL/F)

    Measured: Up to Day 3 for each period

  4. AUC from Time Zero to Last Quantifiable Concentration [AUC(0-t)

    Measured: Up to Day 3 for each period

  5. Apparent Volume of Distribution (Vz/F)

    Measured: Up to Day 3 for each period

  6. Number of Participants Reported for Adverse events, Serious Adverse Events and Adverse Events of Special Interest

    Measured: Up to 3 weeks

  7. Absolute Values for Clinical Laboratory Parameters Over Time

    Measured: Up to 3 weeks

  8. Absolute Values for 12- Lead Electrocardiogram (ECG) Over Time

    Measured: Up to 3 weeks

  9. Absolute Values for Vital Sign Measurements Over Time

    Measured: Up to 3 weeks

  10. Changes from Baseline for Clinical Laboratory Parameters Over Time

    Measured: Up to 3 weeks

  11. Changes from Baseline for 12- Lead ECG Over Time

    Measured: Up to 3 weeks

  12. Changes from Baseline for Vital Sign Measurements Over Time

    Measured: Up to 3 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2024
  2. Study start9 Jul 2024
  3. Primary completion22 Aug 2024
  4. Study completion26 Aug 2024

Resources

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
Crossover
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06497517
Sponsor's protocol ID
222708
Status last verified
Feb 2025
First submitted
5 Jul 2024
Last updated
7 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GSK5464714- Camlipixant in people with Cough, run by Bellus Health Inc. - a GSK company at 1 site in United States.

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 14 inclusion and 19 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 7 Feb 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 States. 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?

Area Under the Plasma Concentration-Time Curve (AUC) from Time Zero to Infinity Post-Dose [AUC(0-inf) (time frame: Up to Day 3 for each period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06497517.

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 7 Feb 2025.

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