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CoughPhase 1NCT06222892

A Study of Camlipixant in Male and Female Healthy Participants and Participants With Hepatic Impairment Aged 18-75 Years of Age

A Phase 1 study testing Camlipixant in people with Cough, run by Bellus Health Inc. - a GSK company at 3 sites in United States.

Completed

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

Official record
Search all trials

Trial summary

The purpose of this study is to assess the effect of Hepatic impairment (HI) on the Pharmacokinetic (PK) profile and safety of Camlipixant. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Cough
What is being tested?
Camlipixant
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
3 sitesUnited States
Study dates
2 Feb 2024to 30 Dec 2024
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Adult male or female participant, greater than or equals to (>=) 18 years and less than or equals to (<=) 75 years of age at the screening visit.
  • Male and female participants must follow protocol-specified contraception guidance.
  • Guidance for Female Participants
  • Female participants of childbearing potential must agree to one of the following methods of contraception: i. Hysteroscopic sterilization or bilateral tubal ligation at least 6 months prior to dosing.
  • Non-hormonal releasing intrauterine device (IUD) or hormonal contraceptives (e.g., oral, IUD, vaginal ring, transdermal patch, depot, implantable, etc.) for at least 3 months prior to dosing and with either a physical (e.g., condom, diaphragm, or other) or a chemical (e.g., spermicide) barrier method from the time of the screening visit.
  • In addition, female participants of childbearing potential will be advised to keep the same birth control method for at least 30 days after dosing.
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  • Female participant must agree not to donate ova from dosing until at least 30 days after dosing.
  • Guidance for male participants. a. Male participants who are not vasectomized for at least 4 months prior to dosing and who are sexually active with a female partner of childbearing potential must be willing to use one of the following acceptable contraceptive methods from dosing until 90 days after dosing.
  • Simultaneous use of condom and hormonal contraceptive (e.g., oral, IUD, vaginal ring, patch, depot, implantable, etc.) or non-hormonal intrauterine device used for at least 3 months prior to dosing for the female partner.
  • Simultaneous use of condom and a diaphragm or cervical cap with spermicide for the female partner.
  • No restrictions are required for a vasectomized male provided his vasectomy has been performed 4 months or more prior to dosing. A male who has been vasectomized less than 4 months prior to dosing must follow the same restrictions as a non-vasectomized male.
  • Female Participants: A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: Is a woman of non-childbearing potential (WONCBP) OR Is a Woman of childbearing potential (WOCBP) and using a contraceptive method that is highly effective, with a failure rate of <1 percent (%), during the study intervention period and for at least 14 days after the last dose of study intervention. The investigator should evaluate potential for contraceptive method failure (e.g., noncompliance, recently initiated) in relationship to the first dose of study intervention.
  • A WOCBP must have a negative highly sensitive pregnancy test urine or serum as required by local regulations) within specify timeframe before the first dose of study intervention. If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
  • The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
  • Participants must weigh at least 50 kilogram (kg) and have a Body mass index (BMI) >= 18.0 and <= 40.0 kilograms per square meter (kg/m^2), at the screening visit.
  • Continuous non-smoker who has not used nicotine- and tobacco-containing products or light smoker (<= 5 cigarettes/day or the equivalent) for the last 3 months prior to study screening.
  • Participant who understands the study procedures in the informed consent form (ICF) and is willing and able to comply with the protocol.
  • Additional inclusion criteria for hepatic impaired participants.
  • Participants aside from HI, be sufficiently healthy for study participation based upon medical history, physical examination, vital signs, ECGs, and screening clinical laboratory profiles, as deemed by the Principal Investigator (PI) or designee, including the following:
  • Seated blood pressure is >= 90/40 millimeters of mercury (mmHg) and <= 160/100 mmHg at the screening visit.
  • Seated heart rate is >= 40 beats per minute (bpm) and <= 99 bpm at the screening visit.
  • Corrected value of the interval between the Q and T waves on the electrocardiogram tracing, corrected QT interval using Fridericia formula (QTcF) is <= 480 milliseconds (msec) and has ECG findings considered normal or not clinically significant by the PI or designee at the screening visit.
  • Estimated creatinine clearance >= 80 milliliters per minute (mL/min) at the screening visit.
  • Total bilirubin <= 6 milligrams per deciliters (mg/dL).
  • Has a score on the Child-Pugh scale at the screening visit as follows:
  • Severe HI: >= 10 and <= 15; or Moderate HI: >= 7 and <= 9; or Mild HI: >= 5 and <= 6.
  • Participant has stable HI as defined by a diagnosis of chronic (>= 6 months), stable (no acute episodes of illness within 30 days prior to dosing due to deterioration in hepatic function) hepatic insufficiency with features of cirrhosis due to any etiology.
  • Additional inclusion criteria for healthy control participants:
  • Medically healthy participants with no clinically significant medical history, physical examination, screening clinical laboratory profiles, vital signs and ECGs, as deemed by the PI or designee, including the following:
  • Seated blood pressure is >= 90/40 mmHg and <= 140/90 mmHg at the screening visit.
  • Seated heart rate is >= 40 bpm and <= 99 bpm at the screening visit.
  • QTcF interval is <= 450 msec and has ECG findings considered normal or not clinically significant by the PI or designee at the screening visit.
  • QTc <= 480 msec in participants with bundle branch block.
  • Aspartate aminotransferase (AST), Alanine aminotransferase (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 times upper limit of normal may be repeated once.

Who cannot join

  • Mentally or legally incapacitated participants or has significant emotional problems at the time of the screening visit or are expected during the conduct of the study.
  • Participants with surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the participant's safety in case of participation in the study.
  • Participants with history or presence of liver or other solid organ transplant.
  • Participants with history of acute pancreatitis within 1 year of study entry.
  • Participant with history or presence of hypersensitivity or idiosyncratic reaction to the study drug or related compounds.
  • Participant who has received any Coronavirus Disease-2019 (COVID-19) vaccine within 14 days prior to dosing.
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  • Participant who is unable to refrain from or anticipates the use of prohibited prescription or non-prescription medication, herbal remedies, or supplements.
  • Participant with history or presence of drug abuse within the past 6 months prior to dosing. Positive drug screen due to prescription drug use in hepatic impaired participants will be allowed if approved by PI on a case by case basis.
  • Participation in another clinical study within 30 days (or 5 half-lives, whichever is longer) prior to dosing. The 30 day window will be derived from the date of the last blood collection or dosing, whichever is later, in the previous study to Day 1 of the current study.
  • Participants with positive pre-study drug/alcohol screen, including tetrahydrocannabinol (THC) at the screening visit or at check-in, unless the positive drug test is due to prescription drug use that is approved by the PI or designee and sponsor.
  • Participants with positive results for Human immunodeficiency virus (HIV).
  • Participants has positive coronavirus Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) rapid test and/or positive polymerase chain reaction test (based on local procedures) at check-in.
  • Participants with 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.
  • Participants with positive hepatitis C antibody test result at screening or within 3 months prior to starting study intervention.
  • Participants with unhealthy alcohol use, defined as use more than 24 grams (g) pure alcohol per day for male and 12 g for female (12 g equals to approximately 300 milliliters [mL] beer, 100 mL wine, or 25 mL spirits).
  • Participant has been on a diet incompatible with the on study diet, in the opinion of the PI or designee, within the 30 days prior to dosing.
  • Donation of blood or plasma greater than 400 mL within the last 90 days prior to dosing.
  • Donation of bone marrow within the last 6 months prior to dosing.
  • Additional exclusion criteria for hepatic impaired participants:
  • Participant with history or presence of clinically significant medical or psychiatric condition or disease (aside from HI) in the opinion of the PI or designee and Sponsor medical representative.
  • Additional exclusion criteria for healthy control participants:
  • Participant with history or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee and Sponsor medical representative.
  • Participant with history or presence of alcoholism or drug abuse within the past 2 years prior to dosing.
  • Female participant with a positive pregnancy test at the screening visit or at check-in or who is lactating (also applies to female HI participants).

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • GSK Investigational Site

    Miami, Florida, 33136

  • GSK Investigational Site

    Orlando, Florida, 32809

  • GSK Investigational Site

    San Antonio, Texas, 78215

Other trials in United States

About this study

Official title: A Phase 1, Open-label Study to Investigate the Pharmacokinetics and Safety of Camlipixant in Male and Female Participants Aged 18-75 Years of Age With Hepatic Impairment Compared to Matched Healthy Participants With Normal Hepatic Function

The purpose of this study is to assess the effect of Hepatic impairment (HI) on the Pharmacokinetic (PK) profile and safety of Camlipixant.

Conditions
Cough
Being tested
Camlipixant
Keywords
Camlipixant, Healthy participants, Hepatic Impairment, Pharmacokinetic, Safety
Medical subject headings
Cough

What participants receive

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

  • CamlipixantDrug

    Camlipixant was administered.

Study groups in NCT06222892
Study groupRoleWhat they receive
Part 1: Moderate HI ParticipantsExperimentalParticipants with moderate HI received a single dose of camlipixant 50 milligrams (mg) tablet orally on Day 1 in the fasted state.
Receives: Drug: Camlipixant
Part 1: Matched Healthy Participants to Moderate HIExperimentalHealthy participants (matched to participants with moderate HI) received a single dose of camlipixant 50 mg tablet orally on Day 1 in the fasted state.
Receives: Drug: Camlipixant
Part 2: Severe HI ParticipantsExperimentalParticipants with severe HI received a single dose of camlipixant 50 mg tablet orally on Day 1 in the fasted state.
Receives: Drug: Camlipixant
Part 2: Matched Healthy Participants to Severe HIExperimentalHealthy participants (matched to participants with severe HI) received a single dose of camlipixant 50 mg tablet orally on Day 1 in the fasted state.
Receives: Drug: Camlipixant

What is being measured

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

  1. Part 1: Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC[0-inf]) of Camlipixant

    Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of camlipixant. PK analysis was conducted using standard non-compartmental methods.

    Measured: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 and 96 hours post-dose

  2. Part 2: AUC(0-inf) of Camlipixant

    Blood samples were collected at indicated time points for PK analysis of camlipixant. PK analysis was conducted using standard non-compartmental methods.

    Measured: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 and 96 hours post-dose

  3. Part 1: Maximum Observed Plasma Concentration (Cmax) of Camlipixant

    Blood samples were collected at indicated time points for PK analysis of camlipixant. PK analysis was conducted using standard non-compartmental methods.

    Measured: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 and 96 hours post-dose

  4. Part 2: Cmax of Camlipixant

    Blood samples were collected at indicated time points for PK analysis of camlipixant. PK analysis was conducted using standard non-compartmental methods.

    Measured: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 and 96 hours post-dose

Secondary outcomes (20)

  1. Part 1: Number of Participants With Any Adverse Event (AE), Serious Adverse Event (SAE), and Adverse Event of Special Interest (AESI)

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. SAEs are defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect in a participant's offspring; abnormal pregnancy outcomes; is a suspected transmission of any infectious agent via an authorized medicinal product; or other situations as per medical and scientific judgement of the Investigator. AESIs are AEs of scientific interest specific to the drug class. AESIs for this study include the following but not limited to taste disturbance (dysgeusia, hypogeusia, ageusia), oral paresthesia and oral hypoesthesia. Number of participants with any AE, SAE, or AESI were reported.

    Measured: Up to 17 days

  2. Part 2: Number of Participants With Any AE, SAE, and AESI

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. SAEs are defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect in a participant's offspring; abnormal pregnancy outcomes; is a suspected transmission of any infectious agent via an authorized medicinal product; or other situations as per medical and scientific judgement of the Investigator. AESIs are AEs of scientific interest specific to the drug class. AESIs for this study include the following but not limited to taste disturbance (dysgeusia, hypogeusia, ageusia), oral paresthesia and oral hypoesthesia. Number of participants with any AE, SAE, or AESI were reported.

    Measured: Up to 17 days

  3. Part 1: Number of Participants With Clinically Significant Changes in Clinical Chemistry Parameters

    Blood samples were collected to analyze clinical chemical parameters: blood urea nitrogen (BUN)/urea, potassium, creatinine, sodium, calcium, glucose [fasting/non-fasting], creatine phosphokinase (CPK), serum albumin concentration, serum alpha-1-glycoprotein concentration, aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT), alanine aminotransferase (ALT)/serum glutamic-pyruvic transaminase (SGPT), alkaline phosphatase, total bilirubin, direct bilirubin, indirect bilirubin and total protein. Number of participants with clinically significant changes in clinical chemistry parameters has been reported. Clinical significance was determined by the Investigator.

    Measured: Up to Day 5

  4. Part 2: Number of Participants With Clinically Significant Changes in Clinical Chemistry Parameters

    Blood samples were collected to analyze clinical chemical parameters: BUN/urea, potassium, creatinine, sodium, calcium, glucose [fasting/non-fasting], CPK, serum albumin concentration, serum alpha-1-glycoprotein concentration, AST/SGOT, ALT/SGPT, alkaline phosphatase, total bilirubin, direct bilirubin, indirect bilirubin and total protein. Number of participants with clinically significant changes in clinical chemistry parameters has been reported. Clinical significance was determined by the Investigator.

    Measured: Up to Day 5

  5. Part 1: Number of Participants With Clinically Significant Changes in Hematology Parameters

    Blood samples were collected to analyze hematology parameters: platelet count, red blood cell (RBC) count, RBC indices (mean corpuscular volume [MCV], mean corpuscular hemoglobin [MCH], percent reticulocytes), white blood cell (WBC) count with differential (neutrophils, lymphocytes, monocytes, eosinophil, basophils), hemoglobin, and hematocrit. Number of participants with clinically significant changes in hematology parameters has been reported. Clinical significance was determined by the Investigator.

    Measured: Up to Day 5

  6. Part 2: Number of Participants With Clinically Significant Changes in Hematology Parameters

    Blood samples were collected to analyze hematology parameters: platelet count, RBC count, RBC indices (MCV, MCH, percent reticulocytes), WBC count with differential (neutrophils, lymphocytes, monocytes, eosinophil, basophils), hemoglobin, and hematocrit. Number of participants with clinically significant changes in hematology parameters has been reported. Clinical significance was determined by the Investigator.

    Measured: Up to Day 5

  7. Part 1: Number of Participants With Clinically Significant Changes in Urinalysis

    Urine samples were collected to analyze urinalysis parameters: specific gravity; and potential of hydrogen (pH), glucose, protein, blood, ketones, bilirubin, urobilinogen, nitrite, leukocyte esterase which were analyzed by dipstick. Number of participants with clinically significant changes in urinalysis parameters has been reported. Clinical significance was determined by the Investigator.

    Measured: Up to Day 5

  8. Part 2: Number of Participants With Clinically Significant Changes in Urinalysis

    Urine samples were collected to analyze urinalysis parameters: specific gravity; and pH, glucose, protein, blood, ketones, bilirubin, urobilinogen, nitrite, leukocyte esterase which were analyzed by dipstick. Number of participants with clinically significant changes in urinalysis parameters has been reported. Clinical significance was determined by the Investigator.

    Measured: Up to Day 5

  9. Part 1: Number of Participants With Clinically Significant Changes in Vital Signs

    Vital signs including systolic and diastolic blood pressure, pulse rate, respiratory rate, and temperature were measured. Blood pressure and pulse rate measurements were performed with participants in a seated position for at least 5 minutes, except when they were supine or semi-reclined because of study procedures and/or AEs (such as nausea, dizziness). Number of participants with abnormal clinically significant changes in vital signs has been reported. Clinical significance was determined by the Investigator.

    Measured: Up to Day 5

  10. Part 2: Number of Participants With Clinically Significant Changes in Vital Signs

    Vital signs including systolic and diastolic blood pressure, pulse rate, respiratory rate, and temperature were measured. Blood pressure and pulse rate measurements were performed with participants in a seated position for at least 5 minutes, except when they were supine or semi-reclined because of study procedures and/or AEs (such as nausea, dizziness). Number of participants with abnormal clinically significant changes in vital signs has been reported. Clinical significance was determined by the Investigator.

    Measured: Up to Day 5

  11. Part 1: Number of Participants With Clinically Significant Changes in 12 Lead Electrocardiogram (ECG) Findings

    ECG values included measurements of heart rate, PR interval, QRS interval, uncorrected QT interval, and corrected QT interval using Fridericia formula (QTcF). 12-lead ECG was recorded with the participant in a supine position for at least 5 minutes. Number of participants with clinically significant 12-lead ECG findings has been reported. Clinical significance was determined by the Investigator.

    Measured: Up to Day 5

  12. Part 2: Number of Participants With Clinically Significant Changes in 12 Lead ECG Findings

    ECG values included measurements of heart rate, PR interval, QRS interval, uncorrected QT interval, and QTcF. 12-lead ECG was recorded with the participant in a supine position for at least 5 minutes. Number of participants with clinically significant 12-lead ECG findings has been reported. Clinical significance was determined by the Investigator.

    Measured: Up to Day 5

  13. Part 1: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Camlipixant

    Blood samples were collected at indicated time points for PK analysis of camlipixant. PK analysis was conducted using standard non-compartmental methods.

    Measured: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 and 96 hours post-dose

  14. Part 2: Tmax of Camlipixant

    Blood samples were collected at indicated time points for PK analysis of camlipixant. PK analysis was conducted using standard non-compartmental methods.

    Measured: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 and 96 hours post-dose

  15. Part 1: Terminal Elimination Half-life (T1/2) Following Administration of Camlipixant

    Blood samples were collected at indicated time points for PK analysis of camlipixant. PK analysis was conducted using standard non-compartmental methods.

    Measured: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 and 96 hours post-dose

  16. Part 2: T1/2 Following Administration of Camlipixant

    Blood samples were collected at indicated time points for PK analysis of camlipixant. PK analysis was conducted using standard non-compartmental methods.

    Measured: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 and 96 hours post-dose

  17. Part 1: Apparent Oral Clearance (CL/F) of Camlipixant

    Blood samples were collected at indicated time points for PK analysis of camlipixant. PK analysis was conducted using standard non-compartmental methods.

    Measured: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 and 96 hours post-dose

  18. Part 2: CL/F of Camlipixant

    Blood samples were collected at indicated time points for PK analysis of camlipixant. PK analysis was conducted using standard non-compartmental methods.

    Measured: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 and 96 hours post-dose

  19. Part 1: Apparent Oral Volume of Distribution (Vz/F) of Camlipixant

    Blood samples were collected at indicated time points for PK analysis of camlipixant. PK analysis was conducted using standard non-compartmental methods.

    Measured: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 and 96 hours post-dose

  20. Part 2: Vz/F of Camlipixant

    Blood samples were collected at indicated time points for PK analysis of camlipixant. PK analysis was conducted using standard non-compartmental methods.

    Measured: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 and 96 hours post-dose

Timeline

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

  1. First posted25 Jan 2024
  2. Study start2 Feb 2024
  3. Primary completion17 Dec 2024
  4. Study completion30 Dec 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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06222892
Sponsor's protocol ID
221852
Status last verified
Dec 2025
First submitted
16 Jan 2024
Last updated
7 Jan 2026
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 Camlipixant in people with Cough, run by Bellus Health Inc. - a GSK company at 3 sites 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 34 inclusion and 24 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 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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?

Yes. Results are posted in the registry (first posted 7 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Part 1: Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC[0-inf]) of Camlipixant (time frame: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 and 96 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?

On the ClinicalTrials.gov record for NCT06222892.

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 Jan 2026.

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