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| ID | Type | Description | Link |
|---|---|---|---|
| BUS-P1-11 | Other Identifier | Bellus Health Inc |
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This is a phase 1, 2-part, open-label, fixed-sequence study evaluating the effect of rifampin (part 1) and rabeprazole (part 2) on the pharmacokinetics of a single dose of camlipixant (BLU-5937) 50 mg tablet in healthy participants under fasting conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Camlipixant 50 mg + Rifampin 600 mg | Experimental | Participants will receive a single oral dose of camlipixant 50 milligram (mg) tablet on Day 1, followed by repeat oral doses (2*300 mg) of rifampin 600 mg capsules, once daily (QD) from Days 4 to 12, with co-administration of a single oral dose of 50 mg camlipixant tablet with rifampin capsules on Day 11. There will be a washout of at least 3 days between the dose of camlipixant on Day 1 and the dose of rifampin on Day 4. |
|
| Part 2: Camlipixant 50 mg + Rabeprazole 20 mg | Experimental | Participants will receive a single oral dose of camlipixant 50 mg tablet on Day 1, followed by repeat oral doses of 20 mg rabeprazole enteric-coated tablets, once daily (QD) from Days 4 to 11, with co-administration of a single oral dose of 50 mg camlipixant tablet with rabeprazole enteric-coated tablet on Day 10. There will be a washout of at least 3 days between the dose of camlipixant on Day 1 and the dose of rabeprazole on Day 4 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Camlipixant | Drug | Camlipixant will be administered |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC[0-Infinity]) 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, 0.16, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 36, and 48 hours post-dose on Day 1 and Day 11 |
| Part 2: AUC(0-Infinity) 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, 0.16, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 36, and 48 hours post-dose on Day 1 and Day 10 |
| Part 1: Area Under the Plasma Concentration-time Curve From Time Zero Until the Last Observed Concentration (AUC[0-t]) 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, 0.16, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 36, and 48 hours post-dose on Day 1 and Day 11 |
| Part 2: AUC(0-t) 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, 0.16, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 36, and 48 hours post-dose on Day 1 and Day 10 |
| Part 1: Maximum Observed 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Time to Reach Maximum Observed 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, 0.16, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 36, and 48 hours post-dose on Day 1 and Day 11 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Québec | Quebec | G1P 0A2 | Canada |
A total of 42 participants were enrolled (20 participants in Part 1 and 22 participants in Part 2) in this study. Only 32 participants (10 participants were never dosed) were dosed into the study to receive either camlipixant + rifampin or camlipixant + rabeprazole creating the Safety Population.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part 1: Camlipixant 50 mg + Rifampin 600 mg | Participants received a single oral dose of camlipixant 50 milligram (mg) tablet on Day 1, followed by repeat oral doses (2*300 mg) of rifampin 600 mg capsules, once daily (QD) from Days 4 to 12, with co-administration of a single oral dose of 50 mg camlipixant tablet with rifampin capsules on Day 11. There was a washout of at least 3 days between the dose of camlipixant on Day 1 and the dose of rifampin on Day 4. |
| FG001 | Part 2: Camlipixant 50 mg + Rabeprazole 20 mg | Participants received a single oral dose of camlipixant 50 mg tablet on Day 1, followed by repeat oral doses of 20 mg rabeprazole enteric-coated tablets, once daily (QD) from Days 4 to 11, with co-administration of a single oral dose of 50 mg camlipixant tablet with rabeprazole enteric-coated tablet on Day 10. There was a washout of at least 3 days between the dose of camlipixant on Day 1 and the dose of rabeprazole on Day 4. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Part 1 (Up to Day 22) |
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| Part 2 (up to Day 21) |
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Baseline characteristics are reported for the Safety Population which consisted of all participants who received at least one dose of any study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Part 1: Camlipixant 50 mg + Rifampin 600 mg | Participants received a single oral dose of camlipixant 50 milligram (mg) tablet on Day 1, followed by repeat oral doses (2*300 mg) of rifampin 600 mg capsules, once daily (QD) from Days 4 to 12, with co-administration of a single oral dose of 50 mg camlipixant tablet with rifampin capsules on Day 11. There was a washout of at least 3 days between the dose of camlipixant on Day 1 and the dose of rifampin on Day 4. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| 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 Plasma Concentration-time Curve From Time Zero to Infinity (AUC[0-Infinity]) 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. | Pharmacokinetic Parameter Population comprised of all participants for whom the Day 1 and Day 11 (Part 1) PK profiles of Camlipixant were adequately characterized, specifically, when administered alone and in combination with Rifampin (Part 1). | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours*nanograms per milliliter | Pre-dose, 0.16, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 36, and 48 hours post-dose on Day 1 and Day 11 |
|
Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
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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: Camlipixant 50 mg | Participants received a single oral dose of 50 mg camlipixant tablet on Day 1. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chromaturia | Renal and urinary disorders | MedDRA 26.0 | 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 | Jul 20, 2023 | Aug 7, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 2, 2023 | Aug 7, 2024 | 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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| ID | Term |
|---|---|
| D064750 | Rabeprazole |
| D012293 | Rifampin |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Rabeprazole | Drug | Rabeprazole will be administered |
|
| Rifampin | Drug | Rifampin will be administered. |
|
| Pre-dose, 0.16, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 36, and 48 hours post-dose on Day 1 and Day 11 |
| 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, 0.16, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 36, and 48 hours post-dose on Day 1 and Day 10 |
| 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, 0.16, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 36, and 48 hours post-dose on Day 1 and Day 10 |
| 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, 0.16, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 36, and 48 hours post-dose on Day 1 and Day 11 |
| 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, 0.16, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 36, and 48 hours post-dose on Day 1 and Day 10 |
| Part 1: Percentage of AUC0-Infinity Due to Extrapolation From the Time of the Last Observed Concentration to Infinity (% AUC Extrapolation) of Camlipixant | Blood samples were collected at indicated time points for PK analysis of Camlipixant. PK analysis was conducted using standard non-compartmental methods. Percentage of AUC extrapolation was calculated as [1 - (AUC0-t/AUC0-inf)] * 100. | Pre-dose, 0.16, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 36, and 48 hours post-dose on Day 1 and Day 11 |
| Part 2: % AUC Extrapolation of Camlipixant | Blood samples were collected at indicated time points for PK analysis of Camlipixant. PK analysis was conducted using standard non-compartmental methods. Percentage of AUC extrapolation was calculated as [1 - (AUC0-t/AUC0-inf)] * 100. | Pre-dose, 0.16, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 36, and 48 hours post-dose on Day 1 and Day 10 |
| Part 1: Terminal Elimination Rate Constant 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, 0.16, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 36, and 48 hours post-dose on Day 1 and Day 11 |
| Part 2: Terminal Elimination Rate Constant 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, 0.16, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 36, and 48 hours post-dose on Day 1 and Day 10 |
| Part 1: Apparent 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, 0.16, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 36, and 48 hours post-dose on Day 1 and Day 11 |
| 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, 0.16, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 36, and 48 hours post-dose on Day 1 and Day 10 |
| 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, 0.16, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 36, and 48 hours post-dose on Day 1 and Day 11 |
| 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, 0.16, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 36, and 48 hours post-dose on Day 1 and Day 10 |
| Part 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs) and Treatment-emergent Adverse Events of Medical Interest (TEAEMIs) | An adverse event (AE) is defined as any untoward medical occurrence in a participant who is administered a pharmaceutical product and which does not necessarily have a causal relationship with the treatment. Serious adverse events (SAEs) are defined as any untoward medical occurrence that; at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician, is associated with liver injury and impaired liver function. Adverse events of medical interest (AEMIs) are AEs of scientific interest specific to the drug class. Treatment-emergent events (i.e., TEAEs, TESAEs and TEAEMIs) were defined as events that commence on or after the time of first study drug administration. | Up to Day 22 for Part1 (Day1 post-dose until Day4 pre-dose of rifampin [Camlipixant 50mg];From Day4 dosing until Day11 pre-dose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study [Day 22] [Camlipixant 50mg+Rifampin 600mg] |
| Part 2: Number of Participants With TEAEs, TESAEs and TEAEMIs | An adverse event (AE) is defined as any untoward medical occurrence in a participant who is administered a pharmaceutical product and which does not necessarily have a causal relationship with the treatment. Serious adverse events (SAEs) are defined as any untoward medical occurrence that; at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician, is associated with liver injury and impaired liver function. Adverse events of medical interest (AEMIs) are AEs of scientific interest specific to the drug class. Treatment-emergent events (i.e., TEAEs, TESAEs and TEAEMIs) were defined as events that commence on or after the time of first study drug administration. | Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg] |
| Part 1: Number of Participants With Abnormal Clinically Significant Changes in 12-Lead Electrocardiogram (ECG) Findings | A 12-lead ECG was recorded with the participant in a semi-recumbent or supine position, after 5 minutes of rest using an ECG machine. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for the number of participants with abnormal clinically significant 12-Lead ECG findings have been presented. | Day 4, Day 11, and Day 13 |
| Part 2: Number of Participants With Abnormal Clinically Significant Changes in 12-Lead ECG Findings | A 12-lead ECG was recorded with the participant in a semi-recumbent or supine position, after 5 minutes of rest using an ECG machine. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for the number of participants with abnormal clinically significant 12-Lead ECG findings have been presented. | Day 4, Day 10, and Day 12 |
| Part 1: Number of Participants With Abnormal Clinically Significant Changes in Vital Signs: Diastolic Blood Pressure (DBP), Systolic Blood Pressure (SBP), and Heart Rate | Vital signs including diastolic blood pressure (DBP), systolic Blood Pressure (SBP), and heart rate were measured in a sitting position after resting for at least 5 minutes. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for the number of participants with abnormal clinically significant changes for vital signs have been presented. | Day 11 and Day 13 |
| Part 2: Number of Participants With Abnormal Clinically Significant Changes in Vital Signs: DBP, SBP, and Heart Rate | Vital signs including DBP, SBP, and heart rate were measured in a sitting position after resting for at least 5 minutes. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for the number of participants with abnormal clinically significant changes for vital signs have been presented. | Day 10 and Day 12 |
| Part 1: Number of Participants With Abnormal Clinically Significant Changes in Vital Signs: Respiratory Rate and Oral Temperature | Vital signs including respiratory rate and oral temperature were measured after resting for at least 5 minutes in a sitting position. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for the number of participants with abnormal clinically significant changes for vital signs have been presented. | Day 13 |
| Part 2: Number of Participants With Abnormal Clinically Significant Changes in Vital Signs: Respiratory Rate and Oral Temperature | Vital signs including respiratory rate and oral temperature were measured after resting for at least 5 minutes in a sitting position. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for the number of participants with abnormal clinically significant changes for vital signs have been presented. | Day 12 |
| Part 1: Number of Participants With Abnormal Clinically Significant Changes in Physical Examination | Physical examination included assessment of the head, eyes, ears, nose, throat, neck, chest, lungs, abdomen, musculoskeletal, dermatological, cardiovascular/peripheral vascular, and general neurological examination. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for the number of participants with abnormal clinically significant changes in physical examination has been presented. | Up to Day 13 |
| Part 2: Number of Participants With Abnormal Clinically Significant Changes in Physical Examination | Physical examination included assessment of the head, eyes, ears, nose, throat, neck, chest, lungs, abdomen, musculoskeletal, dermatological, cardiovascular/peripheral vascular, and general neurological examination. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for the number of participants with abnormal clinically significant changes in physical examination has been presented. | Up to Day 12 |
| Part 1: Number of Participants With Abnormal Clinically Significant Changes in Hematology Parameters | Blood samples were collected to analyze hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Hematocrit, Hemoglobin, Platelets, and Erythrocytes. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Number of participants with abnormal clinically significant changes in hematology parameters were reported. | Up to Day 13 |
| Part 2: Number of Participants With Abnormal Clinically Significant Changes in Hematology Parameters | Blood samples were collected to analyze hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Hematocrit, Hemoglobin, Platelets, and Erythrocytes. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Number of participants with abnormal clinically significant changes in hematology parameters were reported. | Up to Day 12 |
| Part 1: Number of Participants With Abnormal Clinically Significant Changes in Clinical Chemistry Parameters | Blood samples were collected to analyze clinical chemical parameters: albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, calcium, chloride, creatinine kinase, creatinine, gamma glutamyl transferase, glucose, phosphate, potassium, sodium, total, direct, and indirect bilirubin, protein, urea, and urate. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Number of Participants with abnormal clinically significant changes in clinical chemistry parameters were reported. | Up to Day 13 |
| Part 2: Number of Participants With Abnormal Clinically Significant Changes in Clinical Chemistry Parameters | Blood samples were collected to analyze clinical chemical parameters: albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, calcium, chloride, creatinine kinase, creatinine, gamma glutamyl transferase, glucose, phosphate, potassium, sodium, total, direct, and indirect bilirubin, protein, urea, and urate. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Number of Participants with abnormal clinically significant changes in clinical chemistry parameters were reported. | Up to Day 12 |
| Part 1: Number of Participants With Abnormal Clinically Significant Changes in Coagulation Parameters | Blood samples were collected to analyze coagulation parameters: activated partial thromboplastin time, prothrombin time international (Intl.) normalized ratio, and prothrombin time. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Number of Participants with abnormal clinically significant changes in coagulation parameters were reported. | Up to Day 13 |
| Part 2: Number of Participants With Abnormal Clinically Significant Changes in Coagulation Parameters | Blood samples were collected to analyze coagulation parameters: activated partial thromboplastin time, prothrombin time international (Intl.) normalized ratio, and prothrombin time. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Number of Participants with abnormal clinically significant changes in coagulation parameters were reported. | Up to Day 12 |
| Part 1: Number of Participants With Abnormal Clinically Significant Changes in Urinalysis | Urine samples were collected to analyze urinalysis parameters: specific gravity and potential of hydrogen (pH). Bilirubin, blood (occult), glucose, ketones, leukocyte esterase, nitrite, protein, urobilinogen were analyzed by dipstick. The dipstick test gives results in a semi-quantitative manner, and results can be read as Negative, Trace, 1+, 2+ indicating proportional concentrations in the urine sample. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Number of Participants with abnormal clinically significant changes in urinalysis parameters were reported. | Up to Day 13 |
| Part 2: Number of Participants With Abnormal Clinically Significant Changes in Urinalysis | Urine samples were collected to analyze urinalysis parameters: specific gravity and potential of hydrogen (pH). Bilirubin, blood (occult), glucose, ketones, leukocyte esterase, nitrite, protein, urobilinogen were analyzed by dipstick. The dipstick test gives results in a semi-quantitative manner, and results can be read as Negative, Trace, 1+, 2+ indicating proportional concentrations in the urine sample. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Number of Participants with abnormal clinically significant changes in urinalysis parameters were reported. | Up to Day 12 |
| COMPLETED |
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| NOT COMPLETED |
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|
| BG001 | Part 2: Camlipixant 50 mg + Rabeprazole 20 mg | Participants received a single oral dose of camlipixant 50 mg tablet on Day 1, followed by repeat oral doses of 20 mg rabeprazole enteric-coated tablets, once daily (QD) from Days 4 to 11, with co-administration of a single oral dose of 50 mg camlipixant tablet with rabeprazole enteric-coated tablet on Day 10. There was a washout of at least 3 days between the dose of camlipixant on Day 1 and the dose of rabeprazole on Day 4. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Race categories (with 0\ | Count of Participants | Participants |
|
|
|
| Primary | Part 2: AUC(0-Infinity) of Camlipixant | Blood samples were collected at indicated time points for PK analysis of Camlipixant. PK analysis was conducted using standard non-compartmental methods. | Pharmacokinetic Parameter Population comprised of all participants for whom the Day 1 and Day 10 (Part 2) PK profiles of Camlipixant, were adequately characterized, specifically, when administered alone and in combination with Rabeprazole (Part 2). | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours*nanograms per milliliter | Pre-dose, 0.16, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 36, and 48 hours post-dose on Day 1 and Day 10 |
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| Primary | Part 1: Area Under the Plasma Concentration-time Curve From Time Zero Until the Last Observed Concentration (AUC[0-t]) of Camlipixant | Blood samples were collected at indicated time points for PK analysis of Camlipixant. PK analysis was conducted using standard non-compartmental methods. | Pharmacokinetic Parameter Population comprised of all participants for whom the Day 1 and Day 11 (Part 1) PK profiles of Camlipixant were adequately characterized, specifically, when administered alone and in combination with Rifampin (Part 1). | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours*nanograms per milliliter | Pre-dose, 0.16, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 36, and 48 hours post-dose on Day 1 and Day 11 |
|
|
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| Primary | Part 2: AUC(0-t) of Camlipixant | Blood samples were collected at indicated time points for PK analysis of Camlipixant. PK analysis was conducted using standard non-compartmental methods. | Pharmacokinetic Parameter Population comprised of all participants for whom the Day 1 and Day 10 (Part 2) PK profiles of Camlipixant, were adequately characterized, specifically, when administered alone and in combination with Rabeprazole (Part 2). | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours*nanograms per milliliter | Pre-dose, 0.16, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 36, and 48 hours post-dose on Day 1 and Day 10 |
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| Primary | Part 1: Maximum Observed 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. | Pharmacokinetic Parameter Population comprised of all participants for whom the Day 1 and Day 11 (Part 1) PK profiles of Camlipixant were adequately characterized, specifically, when administered alone and in combination with Rifampin (Part 1). | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanograms per milliliter | Pre-dose, 0.16, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 36, and 48 hours post-dose on Day 1 and Day 11 |
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| 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. | Pharmacokinetic Parameter Population comprised of all participants for whom the Day 1 and Day 10 (Part 2) PK profiles of Camlipixant, were adequately characterized, specifically, when administered alone and in combination with Rabeprazole (Part 2). | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanograms per milliliter | Pre-dose, 0.16, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 36, and 48 hours post-dose on Day 1 and Day 10 |
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| Secondary | Part 1: Time to Reach Maximum Observed 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. | Pharmacokinetic Parameter Population comprised of all participants for whom the Day 1 and Day 11 (Part 1) PK profiles of Camlipixant were adequately characterized, specifically, when administered alone and in combination with Rifampin (Part 1). | Posted | Median | Full Range | Hours | Pre-dose, 0.16, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 36, and 48 hours post-dose on Day 1 and Day 11 |
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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. | Pharmacokinetic Parameter Population comprised of all participants for whom the Day 1 and Day 10 (Part 2) PK profiles of Camlipixant, were adequately characterized, specifically, when administered alone and in combination with Rabeprazole (Part 2). | Posted | Median | Full Range | Hours | Pre-dose, 0.16, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 36, and 48 hours post-dose on Day 1 and Day 10 |
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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. | Pharmacokinetic Parameter Population comprised of all participants for whom the Day 1 and Day 11 (Part 1) PK profiles of Camlipixant were adequately characterized, specifically, when administered alone and in combination with Rifampin (Part 1). | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours | Pre-dose, 0.16, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 36, and 48 hours post-dose on Day 1 and Day 11 |
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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. | Pharmacokinetic Parameter Population comprised of all participants for whom the Day 1 and Day 10 (Part 2) PK profiles of Camlipixant, were adequately characterized, specifically, when administered alone and in combination with Rabeprazole (Part 2). | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours | Pre-dose, 0.16, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 36, and 48 hours post-dose on Day 1 and Day 10 |
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| Secondary | Part 1: Percentage of AUC0-Infinity Due to Extrapolation From the Time of the Last Observed Concentration to Infinity (% AUC Extrapolation) of Camlipixant | Blood samples were collected at indicated time points for PK analysis of Camlipixant. PK analysis was conducted using standard non-compartmental methods. Percentage of AUC extrapolation was calculated as [1 - (AUC0-t/AUC0-inf)] * 100. | Pharmacokinetic Parameter Population comprised of all participants for whom the Day 1 and Day 11 (Part 1) PK profiles of Camlipixant were adequately characterized, specifically, when administered alone and in combination with Rifampin (Part 1). | Posted | Geometric Mean | Geometric Coefficient of Variation | Percentage of AUC extrapolation | Pre-dose, 0.16, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 36, and 48 hours post-dose on Day 1 and Day 11 |
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| Secondary | Part 2: % AUC Extrapolation of Camlipixant | Blood samples were collected at indicated time points for PK analysis of Camlipixant. PK analysis was conducted using standard non-compartmental methods. Percentage of AUC extrapolation was calculated as [1 - (AUC0-t/AUC0-inf)] * 100. | Pharmacokinetic Parameter Population comprised of all participants for whom the Day 1 and Day 10 (Part 2) PK profiles of Camlipixant, were adequately characterized, specifically, when administered alone and in combination with Rabeprazole (Part 2). | Posted | Geometric Mean | Geometric Coefficient of Variation | Percentage of AUC extrapolation | Pre-dose, 0.16, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 36, and 48 hours post-dose on Day 1 and Day 10 |
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| Secondary | Part 1: Terminal Elimination Rate Constant of Camlipixant | Blood samples were collected at indicated time points for PK analysis of Camlipixant. PK analysis was conducted using standard non-compartmental methods. | Pharmacokinetic Parameter Population comprised of all participants for whom the Day 1 and Day 11 (Part 1) PK profiles of Camlipixant were adequately characterized, specifically, when administered alone and in combination with Rifampin (Part 1). | Posted | Geometric Mean | Geometric Coefficient of Variation | Per hour | Pre-dose, 0.16, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 36, and 48 hours post-dose on Day 1 and Day 11 |
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| Secondary | Part 2: Terminal Elimination Rate Constant of Camlipixant | Blood samples were collected at indicated time points for PK analysis of Camlipixant. PK analysis was conducted using standard non-compartmental methods. | Pharmacokinetic Parameter Population comprised of all participants for whom the Day 1 and Day 10 (Part 2) PK profiles of Camlipixant, were adequately characterized, specifically, when administered alone and in combination with Rabeprazole (Part 2). | Posted | Geometric Mean | Geometric Coefficient of Variation | Per hour | Pre-dose, 0.16, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 36, and 48 hours post-dose on Day 1 and Day 10 |
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| Secondary | Part 1: Apparent 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. | Pharmacokinetic Parameter Population comprised of all participants for whom the Day 1 and Day 11 (Part 1) PK profiles of Camlipixant were adequately characterized, specifically, when administered alone and in combination with Rifampin (Part 1). | Posted | Geometric Mean | Geometric Coefficient of Variation | Liters per hour | Pre-dose, 0.16, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 36, and 48 hours post-dose on Day 1 and Day 11 |
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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. | Pharmacokinetic Parameter Population comprised of all participants for whom the Day 1 and Day 10 (Part 2) PK profiles of Camlipixant, were adequately characterized, specifically, when administered alone and in combination with Rabeprazole (Part 2). | Posted | Geometric Mean | Geometric Coefficient of Variation | Liters per hour | Pre-dose, 0.16, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 36, and 48 hours post-dose on Day 1 and Day 10 |
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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. | Pharmacokinetic Parameter Population comprised of all participants for whom the Day 1 and Day 11 (Part 1) PK profiles of Camlipixant were adequately characterized, specifically, when administered alone and in combination with Rifampin (Part 1). | Posted | Geometric Mean | Geometric Coefficient of Variation | Liters | Pre-dose, 0.16, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 36, and 48 hours post-dose on Day 1 and Day 11 |
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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. | Pharmacokinetic Parameter Population comprised of all participants for whom the Day 1 and Day 10 (Part 2) PK profiles of Camlipixant, were adequately characterized, specifically, when administered alone and in combination with Rabeprazole (Part 2). | Posted | Geometric Mean | Geometric Coefficient of Variation | Liters | Pre-dose, 0.16, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 36, and 48 hours post-dose on Day 1 and Day 10 |
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| Secondary | Part 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs) and Treatment-emergent Adverse Events of Medical Interest (TEAEMIs) | An adverse event (AE) is defined as any untoward medical occurrence in a participant who is administered a pharmaceutical product and which does not necessarily have a causal relationship with the treatment. Serious adverse events (SAEs) are defined as any untoward medical occurrence that; at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician, is associated with liver injury and impaired liver function. Adverse events of medical interest (AEMIs) are AEs of scientific interest specific to the drug class. Treatment-emergent events (i.e., TEAEs, TESAEs and TEAEMIs) were defined as events that commence on or after the time of first study drug administration. | Safety population consisted of all participants who received at least one dose of any study drug. | Posted | Count of Participants | Participants | Up to Day 22 for Part1 (Day1 post-dose until Day4 pre-dose of rifampin [Camlipixant 50mg];From Day4 dosing until Day11 pre-dose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study [Day 22] [Camlipixant 50mg+Rifampin 600mg] |
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| Secondary | Part 2: Number of Participants With TEAEs, TESAEs and TEAEMIs | An adverse event (AE) is defined as any untoward medical occurrence in a participant who is administered a pharmaceutical product and which does not necessarily have a causal relationship with the treatment. Serious adverse events (SAEs) are defined as any untoward medical occurrence that; at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician, is associated with liver injury and impaired liver function. Adverse events of medical interest (AEMIs) are AEs of scientific interest specific to the drug class. Treatment-emergent events (i.e., TEAEs, TESAEs and TEAEMIs) were defined as events that commence on or after the time of first study drug administration. | Safety population consisted of all participants who received at least one dose of any study drug. | Posted | Count of Participants | Participants | Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg] |
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| Secondary | Part 1: Number of Participants With Abnormal Clinically Significant Changes in 12-Lead Electrocardiogram (ECG) Findings | A 12-lead ECG was recorded with the participant in a semi-recumbent or supine position, after 5 minutes of rest using an ECG machine. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for the number of participants with abnormal clinically significant 12-Lead ECG findings have been presented. | Safety population consisted of all participants who received at least one dose of any study drug. | Posted | Count of Participants | Participants | Day 4, Day 11, and Day 13 |
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| Secondary | Part 2: Number of Participants With Abnormal Clinically Significant Changes in 12-Lead ECG Findings | A 12-lead ECG was recorded with the participant in a semi-recumbent or supine position, after 5 minutes of rest using an ECG machine. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for the number of participants with abnormal clinically significant 12-Lead ECG findings have been presented. | Safety population consisted of all participants who received at least one dose of any study drug. | Posted | Count of Participants | Participants | Day 4, Day 10, and Day 12 |
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| Secondary | Part 1: Number of Participants With Abnormal Clinically Significant Changes in Vital Signs: Diastolic Blood Pressure (DBP), Systolic Blood Pressure (SBP), and Heart Rate | Vital signs including diastolic blood pressure (DBP), systolic Blood Pressure (SBP), and heart rate were measured in a sitting position after resting for at least 5 minutes. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for the number of participants with abnormal clinically significant changes for vital signs have been presented. | Safety population consisted of all participants who received at least one dose of any study drug. | Posted | Count of Participants | Participants | Day 11 and Day 13 |
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| Secondary | Part 2: Number of Participants With Abnormal Clinically Significant Changes in Vital Signs: DBP, SBP, and Heart Rate | Vital signs including DBP, SBP, and heart rate were measured in a sitting position after resting for at least 5 minutes. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for the number of participants with abnormal clinically significant changes for vital signs have been presented. | Safety population consisted of all participants who received at least one dose of any study drug. | Posted | Count of Participants | Participants | Day 10 and Day 12 |
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| Secondary | Part 1: Number of Participants With Abnormal Clinically Significant Changes in Vital Signs: Respiratory Rate and Oral Temperature | Vital signs including respiratory rate and oral temperature were measured after resting for at least 5 minutes in a sitting position. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for the number of participants with abnormal clinically significant changes for vital signs have been presented. | Safety population consisted of all participants who received at least one dose of any study drug. | Posted | Count of Participants | Participants | Day 13 |
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| Secondary | Part 2: Number of Participants With Abnormal Clinically Significant Changes in Vital Signs: Respiratory Rate and Oral Temperature | Vital signs including respiratory rate and oral temperature were measured after resting for at least 5 minutes in a sitting position. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for the number of participants with abnormal clinically significant changes for vital signs have been presented. | Safety population consisted of all participants who received at least one dose of any study drug. | Posted | Count of Participants | Participants | Day 12 |
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| Secondary | Part 1: Number of Participants With Abnormal Clinically Significant Changes in Physical Examination | Physical examination included assessment of the head, eyes, ears, nose, throat, neck, chest, lungs, abdomen, musculoskeletal, dermatological, cardiovascular/peripheral vascular, and general neurological examination. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for the number of participants with abnormal clinically significant changes in physical examination has been presented. | Safety population consisted of all participants who received at least one dose of any study drug. | Posted | Count of Participants | Participants | Up to Day 13 |
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| Secondary | Part 2: Number of Participants With Abnormal Clinically Significant Changes in Physical Examination | Physical examination included assessment of the head, eyes, ears, nose, throat, neck, chest, lungs, abdomen, musculoskeletal, dermatological, cardiovascular/peripheral vascular, and general neurological examination. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for the number of participants with abnormal clinically significant changes in physical examination has been presented. | Safety population consisted of all participants who received at least one dose of any study drug. | Posted | Count of Participants | Participants | Up to Day 12 |
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| Secondary | Part 1: Number of Participants With Abnormal Clinically Significant Changes in Hematology Parameters | Blood samples were collected to analyze hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Hematocrit, Hemoglobin, Platelets, and Erythrocytes. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Number of participants with abnormal clinically significant changes in hematology parameters were reported. | Safety population consisted of all participants who received at least one dose of any study drug. | Posted | Count of Participants | Participants | Up to Day 13 |
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| Secondary | Part 2: Number of Participants With Abnormal Clinically Significant Changes in Hematology Parameters | Blood samples were collected to analyze hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Hematocrit, Hemoglobin, Platelets, and Erythrocytes. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Number of participants with abnormal clinically significant changes in hematology parameters were reported. | Safety population consisted of all participants who received at least one dose of any study drug. | Posted | Count of Participants | Participants | Up to Day 12 |
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| Secondary | Part 1: Number of Participants With Abnormal Clinically Significant Changes in Clinical Chemistry Parameters | Blood samples were collected to analyze clinical chemical parameters: albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, calcium, chloride, creatinine kinase, creatinine, gamma glutamyl transferase, glucose, phosphate, potassium, sodium, total, direct, and indirect bilirubin, protein, urea, and urate. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Number of Participants with abnormal clinically significant changes in clinical chemistry parameters were reported. | Safety population consisted of all participants who received at least one dose of any study drug. | Posted | Count of Participants | Participants | Up to Day 13 |
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| Secondary | Part 2: Number of Participants With Abnormal Clinically Significant Changes in Clinical Chemistry Parameters | Blood samples were collected to analyze clinical chemical parameters: albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, calcium, chloride, creatinine kinase, creatinine, gamma glutamyl transferase, glucose, phosphate, potassium, sodium, total, direct, and indirect bilirubin, protein, urea, and urate. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Number of Participants with abnormal clinically significant changes in clinical chemistry parameters were reported. | Safety population consisted of all participants who received at least one dose of any study drug. | Posted | Count of Participants | Participants | Up to Day 12 |
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| Secondary | Part 1: Number of Participants With Abnormal Clinically Significant Changes in Coagulation Parameters | Blood samples were collected to analyze coagulation parameters: activated partial thromboplastin time, prothrombin time international (Intl.) normalized ratio, and prothrombin time. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Number of Participants with abnormal clinically significant changes in coagulation parameters were reported. | Safety population consisted of all participants who received at least one dose of any study drug. | Posted | Count of Participants | Participants | Up to Day 13 |
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| Secondary | Part 2: Number of Participants With Abnormal Clinically Significant Changes in Coagulation Parameters | Blood samples were collected to analyze coagulation parameters: activated partial thromboplastin time, prothrombin time international (Intl.) normalized ratio, and prothrombin time. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Number of Participants with abnormal clinically significant changes in coagulation parameters were reported. | Safety population consisted of all participants who received at least one dose of any study drug. | Posted | Count of Participants | Participants | Up to Day 12 |
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| Secondary | Part 1: Number of Participants With Abnormal Clinically Significant Changes in Urinalysis | Urine samples were collected to analyze urinalysis parameters: specific gravity and potential of hydrogen (pH). Bilirubin, blood (occult), glucose, ketones, leukocyte esterase, nitrite, protein, urobilinogen were analyzed by dipstick. The dipstick test gives results in a semi-quantitative manner, and results can be read as Negative, Trace, 1+, 2+ indicating proportional concentrations in the urine sample. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Number of Participants with abnormal clinically significant changes in urinalysis parameters were reported. | Safety population consisted of all participants who received at least one dose of any study drug. | Posted | Count of Participants | Participants | Up to Day 13 |
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| Secondary | Part 2: Number of Participants With Abnormal Clinically Significant Changes in Urinalysis | Urine samples were collected to analyze urinalysis parameters: specific gravity and potential of hydrogen (pH). Bilirubin, blood (occult), glucose, ketones, leukocyte esterase, nitrite, protein, urobilinogen were analyzed by dipstick. The dipstick test gives results in a semi-quantitative manner, and results can be read as Negative, Trace, 1+, 2+ indicating proportional concentrations in the urine sample. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Number of Participants with abnormal clinically significant changes in urinalysis parameters were reported. | Safety population consisted of all participants who received at least one dose of any study drug. | Posted | Count of Participants | Participants | Up to Day 12 |
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| 0 |
| 16 |
| 0 |
| 16 |
| 3 |
| 16 |
| EG001 | Part 1: Rifampin 600 mg | Participants received repeated oral doses of 2*300 mg rifampin capsules (total dose 600 mg) once daily on Days 4 to 12. | 0 | 16 | 0 | 16 | 14 | 16 |
| EG002 | Part 1: Camlipixant 50 mg+ Rifampin 600 mg | Participants received repeat oral doses (2*300 mg) of rifampin 600 mg capsules, once daily (QD) from Days 4 to 12, with co-administration of a single oral dose of 50 mg camlipixant tablet with rifampin capsules on Day 11. Participants were followed up for adverse events until end of study (up to Day 22) | 0 | 16 | 0 | 16 | 2 | 16 |
| EG003 | Part 2: Camlipixant 50 mg | Participants received a single oral dose of 50 mg camlipixant tablet on Day 1. | 0 | 16 | 0 | 16 | 4 | 16 |
| EG004 | Part 2 : Rabeprazole 20 mg | Participants received repeated oral doses of 1*20 mg rabeprazole enteric-coated tablets once daily on Days 4 to 11. | 0 | 16 | 0 | 16 | 3 | 16 |
| EG005 | Part 2: Camlipixant 50 mg+ Rabeprazole 20 mg | Participants received repeat oral doses of 20 mg rabeprazole enteric-coated tablets, once daily (QD) from Days 4 to 11, with co-administration of a single oral dose of 50 mg camlipixant tablet with rabeprazole enteric-coated tablet on Day 10. Participants were followed up for adverse events until end of study (up to Day 21). | 0 | 16 | 0 | 16 | 0 | 16 |
| Pollakiuria | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
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| Urinary retention | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
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| Abdominal pain lower | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
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| Chills | General disorders | MedDRA 26.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 26.0 | Systematic Assessment |
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| Feeling hot | General disorders | MedDRA 26.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
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| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA 26.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
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| Pharyngeal paraesthesia | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
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| Seborrhoea | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
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| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
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| Photophobia | Eye disorders | MedDRA 26.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
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| Pelvic pain | Reproductive system and breast disorders | MedDRA 26.0 | Systematic Assessment |
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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 |
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| Title | Measurements |
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| TEAEMIs |
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| Title | Measurements |
|---|---|
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| TEAEMIs |
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| Title | Measurements |
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| Title | Measurements |
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