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The purpose of this study is to assess the effect of Hepatic impairment (HI) on the Pharmacokinetic (PK) profile and safety of Camlipixant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Moderate HI Participants | Experimental | Participants with moderate HI received a single dose of camlipixant 50 milligrams (mg) tablet orally on Day 1 in the fasted state. |
|
| Part 1: Matched Healthy Participants to Moderate HI | Experimental | Healthy participants (matched to participants with moderate HI) received a single dose of camlipixant 50 mg tablet orally on Day 1 in the fasted state. |
|
| Part 2: Severe HI Participants | Experimental | Participants with severe HI received a single dose of camlipixant 50 mg tablet orally on Day 1 in the fasted state. |
|
| Part 2: Matched Healthy Participants to Severe HI | Experimental | Healthy participants (matched to participants with severe HI) received a single dose of camlipixant 50 mg tablet orally on Day 1 in the fasted state. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Camlipixant | Drug | Camlipixant was administered. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 |
| 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. | 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 |
| 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. | 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 |
| 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. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Inclusion criteria for all participants
Guidance for Female Participants
a. 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.
ii. 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.
b. In addition, female participants of childbearing potential will be advised to keep the same birth control method for at least 30 days after dosing.
c. 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.
i. 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.
ii. Simultaneous use of condom and a diaphragm or cervical cap with spermicide for the female partner.
b. 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.
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:
Has a score on the Child-Pugh scale at the screening visit as follows:
a. 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:
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.
Exclusion Criteria:
Exclusion criteria for all participants:
Additional exclusion criteria for hepatic impaired participants:
Additional exclusion criteria for healthy control participants:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Miami | Florida | 33136 | United States | ||
| GSK Investigational Site |
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/
Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
A total of 32 participants (16 in Part 1 and 16 in Part 2) were enrolled in this study.
This study consisted of 2 parts - Part 1 and Part 2. In Part 1, participants with moderate hepatic impairment (HI) and matched healthy participants were enrolled. Based on the pharmacokinetic (PK) and safety data from Part 1, only participants with severe HI and their matched healthy participants were enrolled in Part 2, while participants with mild HI were not enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part 1: Moderate HI Participants | Participants with moderate HI received a single dose of camlipixant 50 milligrams (mg) tablet orally on Day 1 in the fasted state. |
| FG001 | Part 1: Matched Healthy Participants to Moderate HI | Healthy participants (matched to participants with moderate HI) received a single dose of camlipixant 50 mg tablet orally on Day 1 in the fasted state. |
| FG002 | Part 2: Severe HI Participants | Participants with severe HI received a single dose of camlipixant 50 mg tablet orally on Day 1 in the fasted state. |
| FG003 | Part 2: Matched Healthy Participants to Severe HI | Healthy participants (matched to participants with severe HI) received a single dose of camlipixant 50 mg tablet orally on Day 1 in the fasted state. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Part 1 (Up to 17 Days) |
| |||||||||||||
| Part 2 (Up to 17 Days) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Part 1: Moderate HI Participants | Participants with moderate HI received a single dose of camlipixant 50 mg tablet orally on Day 1 in the fasted state. |
| BG001 | Part 1: Matched Healthy Participants to Moderate HI |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The analysis was performed on the PK Analysis Set that included all participants who received study intervention and who had at least 1 non-missing PK assessment (non-quantifiable [NQ] values were considered as non-missing values). | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours*nanograms per milliliter | 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 |
|
All-cause mortality, SAEs, and non-SAEs were collected up to 17 days for both Part 1 and Part 2
Safety Analysis Set included all participants who received study intervention.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part 1: Moderate HI Participants | Participants with moderate HI received a single dose of camlipixant 50 mg tablet orally on Day 1 in the fasted state. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA v27.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 25, 2024 | Dec 10, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 7, 2025 | Dec 10, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003371 | Cough |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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This will be an open-label study.
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| Up to 17 days |
| 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. | Up to 17 days |
| 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. | Up to Day 5 |
| 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. | Up to Day 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. | Up to Day 5 |
| 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. | Up to Day 5 |
| 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. | Up to Day 5 |
| 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. | Up to Day 5 |
| 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. | Up to Day 5 |
| 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. | Up to Day 5 |
| 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. | Up to Day 5 |
| 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. | Up to Day 5 |
| 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. | 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 |
| 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. | 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 |
| 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. | 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 |
| 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. | 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 |
| 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. | 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 |
| 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. | 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 |
| 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. | 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 |
| 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. | 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 |
| Orlando |
| Florida |
| 32809 |
| United States |
| GSK Investigational Site | San Antonio | Texas | 78215 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
Healthy participants (matched to participants with moderate HI) received a single dose of camlipixant 50 mg tablet orally on Day 1 in the fasted state.
| BG002 | Part 2: Severe HI Participants | Participants with severe HI received a single dose of camlipixant 50 mg tablet orally on Day 1 in the fasted state. |
| BG003 | Part 2: Matched Healthy Participants to Severe HI | Healthy participants (matched to participants with severe HI) received a single dose of camlipixant 50 mg tablet orally on Day 1 in the fasted state. |
| BG004 | Total | Total of all reporting groups |
| YEARS |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG001 | Part 1: Matched Healthy Participants to Moderate HI | Healthy participants (matched to participants with moderate HI) received a single dose of camlipixant 50 mg tablet orally on Day 1 in the fasted state. |
|
|
| Primary | 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. | The analysis was performed on the PK Analysis Set that included all participants who received study intervention and who had at least 1 non-missing PK assessment (NQ values were considered as non-missing values). | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours*nanograms per milliliter | 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 |
|
|
|
| Primary | 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. | The analysis was performed on the PK Analysis Set that included all participants who received study intervention and who had at least 1 non-missing PK assessment (NQ values were considered as non-missing values). | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanograms per milliliter | 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 |
|
|
|
| Primary | 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. | The analysis was performed on the PK Analysis Set that included all participants who received study intervention and who had at least 1 non-missing PK assessment (NQ values were considered as non-missing values). | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanograms per milliliter | 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 | 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. | The analysis was performed on the Safety Analysis Set that included all participants who received study intervention. | Posted | Count of Participants | Participants | Up to 17 days |
|
|
|
| Secondary | 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. | The analysis was performed on the Safety Analysis Set that included all participants who received study intervention. | Posted | Count of Participants | Participants | Up to 17 days |
|
|
|
| Secondary | 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. | The analysis was performed on the Safety Analysis Set that included all participants who received study intervention. | Posted | Count of Participants | Participants | Up to Day 5 |
|
|
|
| Secondary | 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. | The analysis was performed on the Safety Analysis Set that included all participants who received study intervention. | Posted | Count of Participants | Participants | Up to Day 5 |
|
|
|
| Secondary | 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. | The analysis was performed on the Safety Analysis Set that included all participants who received study intervention. | Posted | Count of Participants | Participants | Up to Day 5 |
|
|
|
| Secondary | 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. | The analysis was performed on the Safety Analysis Set that included all participants who received study intervention. | Posted | Count of Participants | Participants | Up to Day 5 |
|
|
|
| Secondary | 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. | The analysis was performed on the Safety Analysis Set that included all participants who received study intervention. | Posted | Count of Participants | Participants | Up to Day 5 |
|
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| Secondary | 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. | The analysis was performed on the Safety Analysis Set that included all participants who received study intervention. | Posted | Count of Participants | Participants | Up to Day 5 |
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| Secondary | 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. | The analysis was performed on the Safety Analysis Set that included all participants who received study intervention. | Posted | Count of Participants | Participants | Up to Day 5 |
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| Secondary | 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. | The analysis was performed on the Safety Analysis Set that included all participants who received study intervention. | Posted | Count of Participants | Participants | Up to Day 5 |
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| Secondary | 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. | The analysis was performed on the Safety Analysis Set that included all participants who received study intervention. | Posted | Count of Participants | Participants | Up to Day 5 |
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| Secondary | 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. | The analysis was performed on the Safety Analysis Set that included all participants who received study intervention. | Posted | Count of Participants | Participants | Up to Day 5 |
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| Secondary | 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. | The analysis was performed on the PK Analysis Set that included all participants who received study intervention and who had at least 1 non-missing PK assessment (NQ values were considered as non-missing values). | Posted | Median | Full Range | Hours | 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 |
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| Secondary | 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. | The analysis was performed on the PK Analysis Set that included all participants who received study intervention and who had at least 1 non-missing PK assessment (NQ values were considered as non-missing values). | Posted | Median | Full Range | Hours | 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 |
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| Secondary | 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. | The analysis was performed on the PK Analysis Set that included all participants who received study intervention and who had at least 1 non-missing PK assessment (NQ values were considered as non-missing values). | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours | 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 |
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| Secondary | 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. | The analysis was performed on the PK Analysis Set that included all participants who received study intervention and who had at least 1 non-missing PK assessment (NQ values were considered as non-missing values). | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours | 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 |
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| Secondary | 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. | The analysis was performed on the PK Analysis Set that included all participants who received study intervention and who had at least 1 non-missing PK assessment (NQ values were considered as non-missing values). | Posted | Geometric Mean | Geometric Coefficient of Variation | Liters per hour | 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 |
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| Secondary | 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. | The analysis was performed on the PK Analysis Set that included all participants who received study intervention and who had at least 1 non-missing PK assessment (NQ values were considered as non-missing values). | Posted | Geometric Mean | Geometric Coefficient of Variation | Liters per hour | 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 |
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| Secondary | 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. | The analysis was performed on the PK Analysis Set that included all participants who received study intervention and who had at least 1 non-missing PK assessment (NQ values were considered as non-missing values). | Posted | Geometric Mean | Geometric Coefficient of Variation | Liters | 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 |
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| Secondary | 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. | The analysis was performed on the PK Analysis Set that included all participants who received study intervention and who had at least 1 non-missing PK assessment (NQ values were considered as non-missing values). | Posted | Geometric Mean | Geometric Coefficient of Variation | Liters | 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 |
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| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | Part 1: Matched Healthy Participants to Moderate HI | Healthy participants (matched to participants with moderate HI) received a single dose of camlipixant 50 mg tablet orally on Day 1 in the fasted state. | 0 | 8 | 0 | 8 | 0 | 8 |
| EG002 | Part 2: Severe HI Participants | Participants with severe HI received a single dose of camlipixant 50 mg tablet orally on Day 1 in the fasted state. | 0 | 8 | 0 | 8 | 2 | 8 |
| EG003 | Part 2: Matched Healthy Participants to Severe HI | Healthy participants (matched to participants with severe HI) received a single dose of camlipixant 50 mg tablet orally on Day 1 in the fasted state. | 0 | 8 | 0 | 8 | 0 | 8 |
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
| D013568 | Pathological Conditions, Signs and Symptoms |
| Any AESI |
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| Any AESI |
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