Pulmonary Disease, Chronic Obstructive
Conditions
Keywords
bystander, inhalation powder, monodose device, COPD, pharmacokinetics, safety, Healthy, CCI15106, tolerability
Brief summary
This single and repeat increasing dose study will collect information on safety, tolerability and drug levels in the body of the CCI15106 inhalation powder. The study will also look at the level of CCI15106 that will be released into the air and may be found in the blood of the people standing around the person inhaling it (bystanders). This is a two-part study in which Part 1 will enroll healthy subjects and look at environmental and bystander exposure and Part 2 will enroll subjects with moderate COPD. Approximately 36 healthy subjects and approximately 22 subjects with COPD will be randomized in this study for dosing. The total study duration will be 82 days for Cohort A Part 1; 75 days for Cohort B Part 1 and Cohort C Part 1; 77 days for Cohort A Part 2; and 90 days for Cohort B Part 2.
Interventions
DRUGCCI15106
One capsule (single dose or repeat dose) of 30 mg of CCI15106 will be administered to healthy subjects and subjects with COPD via inhalation route using Monodose RS01 device. The morning dose will be taken in fasting state and for repeat dose; the evening dose will be taken at least 2 hours after food.
DRUGPlacebo
One capsule of placebo will be administered to healthy subjects and subjects with COPD via inhalation route using Monodose RS01 device. The morning dose will be taken in fasting state and for repeat dose; the evening dose will be taken at least 2 hours after food.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
This is a double blind, randomized study and subject and investigator will be blinded.
Intervention model description
In this study, subjects will be randomized to receive either study drug or placebo in a parallel manner.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
Some important Inclusion Criteria: For healthy subjects and bystanders: * 18 to 65 years of age. * Healthy as determined by a doctor. * Men who agree to use contraception during the treatment period and for at least 7 months after the last dose of study medicine and agree not to donate sperm during this period. * Women who are not pregnant or breastfeeding, and not of childbearing potential. For subjects with COPD: * 40 to 75 years of age. * Diagnosed with moderate COPD by a doctor. * Have breathing test results that are consistent with moderate COPD as defined in the study protocol. * A smoker or an ex-smoker. * Men who agree to use contraception during the treatment period and for at least 7 months after the last dose of study medicine and agree not to donate sperm during this period. * Women who are not pregnant or breastfeeding, and not of childbearing potential. Some Important
Exclusion criteria
For healthy subjects and bystanders: * History of liver disease. * Use of over-the-counter or prescription drugs (including vitamins) 7 days before the study until completion of the follow-up visit. * Participation in the study would result in loss of more than 500 milliliter (mL) of blood within 3 months. * Participation in another clinical trial with an investigational product within about 3 months before this study. * Positive drug/alcohol screen. * Regular use of known drugs of abuse. * Regular alcohol consumption within 3 months before the study. * Breath test indicative of smoking at study start. * Documented lactose allergy/intolerance. * Men whose partner is pregnant or breastfeeding cannot participate. * Certain blood test results may not allow subjects to participate, as described in the study protocol. For subjects with COPD: * History of liver disease. * Poorly controlled COPD disease as, for example, more than 2 exacerbations of COPD per year. * Some respiratory conditions, like for example active tuberculosis, lung cancer or any other respiratory condition. Subjects with other respiratory conditions (for example, clinically significant: asthma, pulmonary fibrosis, bronchiectasis) are excluded if these conditions are the primary cause of their respiratory symptoms. * Unstable or uncontrolled cardiac disease. * Problems with kidney function as defined in the study protocol. * Past or current medical conditions or diseases that are not well controlled. * Subjects are not allowed to take oral corticosteroids from 4 weeks prior to screening and for the duration of the study. * Subjects taking medications for any chronic conditions have to be on stable doses for 4 weeks before screening and until after study treatment is finished. * Use of short-acting inhaled bronchodilators is allowed, but subjects must be able to stop their medications several times during the study. * Use of long-acting bronchodilators is allowed, but subjects must be able to change the schedule of their medications twice during the study. * Participation in the study would result in loss of more than 500 mL within 3 months. * Participation in another clinical trial with an investigational product within about 3 months before this study. * Positive drug/alcohol screen. * Regular use of known drugs of abuse. * Regular alcohol consumption within 3 months before the study. * Unable to refrain from smoking for certain periods during the study (maximum about 6 hours). * Documented lactose allergy/intolerance. * Men whose partner is pregnant or breastfeeding cannot participate. * Certain blood test results may not allow subjects to participate, as described in the study protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C | Days 1, 7 and 14: 20 and 60 minutes post-dose | Static air samples were collected on filters within air pumps positioned in two locations (bench and corner) in the room. Sampling devices attached to sampling pumps were used to measure CCI15106 concentration. Fixed location concentrations were measured in corner of room and on bench at back of room over 20 minutes and 60 minutes post-dosing. |
| Part 2 Cohort B: t1/2 After Repeated Dose Administration of CCI15106 60 mg | Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day14: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose | Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of t1/2 data. |
| Part 1: Concentration of CCI15106 in Plasma of Bystanders: Cohort C | Days 1, 7 and 14: pre-dose, 15 minutes post-dose | Blood samples were collected from bystanders 15 minutes after dosing at indicated time points. Bystander PK population consisted of participants who were present at least once in the room with the participant receiving the dose, undergo plasma PK sampling and had post-dose concentration result. |
| Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Bystander: Cohort C | Days 1, 7 and 14: 15 minutes post-dose | Personal exposure air samples were collected on filters placed on each bystander after the first daily dose at indicated time points. The filters were used to measure CCI15106 concentration in the person's breathing zone. Fixed location concentrations were measured near window, near door, back to wall and facing wall in the dosing room over 15 minutes post-dose. Each bystander had a filter attached to their study clothing. The filters were measured for CCI15106. This was a single measurement from the filter for each bystsander. The locations (near window, near door, back to wall and facing wall) were just to record where the bystander was located in the room. |
| Part 1 Cohort A: Number of Participants With Non-serious Adverse Events (NSAEs) and Serious Adverse Events (SAEs) in CCI15106 | Up to 51 days | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is 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. Safety population comprised of all participants who received at least one dose of study treatment during the study. |
| Part 1 Cohort B: Number of Participants With NSAEs and SAEs in CCI15106 | Up to 46 days | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is 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. |
| Part 1 Cohort C: Number of Participants With NSAEs and SAEs in Bystanders | Up to 46 days | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is 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. |
| Part 2 Cohort A: Number of Participants With NSAEs and SAEs | Up to 33 days | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is 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. |
| Part 2 Cohort B: Number of Participants With NSAEs and SAEs | Up to 46 days | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is 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. |
| Part 1: Number of Participants With Hematology Values of Potential Clinical Importance (PCI) in CCI15106 | Up to 51 days | PCI ranges for the hematology parameters were as follows: hematocrit (high: \>0.54 proportion of red blood cell \[RBC\] in blood for male, \>0.54 proportion of RBC in blood for female), hemoglobin (high: \>180 grams \[g\]/L in male, \>180 g/L in female), lymphocytes (low: \<0.8 10\^9/L), neutrophil count (low: \<1.5 10\^9/L) and platelet count (low: \<100 10\^9/L and high: 550 10\^9/L). Data for the participants with high and low values has been reported. |
| Part 1: Number of Participants With Hematology Values of PCI in Bystanders | Up to 46 days | PCI ranges for the hematology parameters were as follows: hematocrit (high: \>0.54 proportion of RBC in blood for male, \>0.54 proportion of RBC in blood for female), hemoglobin (high: \>180 g/L in male, \>180 g/L in female), lymphocytes (low: \<0.8 10\^9/L), neutrophil count (low: \<1.5 10\^9/L) and platelet count (low: \<100 10\^9/L and high: 550 10\^9/L). Data for the participants with high and low values has been reported. |
| Part 2: Number of Participants With Hematology Values of PCI | Up to 46 days | PCI ranges for the hematology parameters were as follows: hematocrit (high: \>0.54 proportion of RBC in blood for male, \>0.54 proportion of RBC in blood for female), hemoglobin (high: \>180 g/L in male, \>180 g/L in female), lymphocytes (low: \<0.8 10\^9/L), neutrophil count (low: \<1.5 10\^9/L) and platelet count (low: \<100 10\^9/L and high: 550 10\^9/L). Data for the participants with high and low values has been reported. |
| Part 1: Number of Participants With Clinical Chemistry Values of PCI in CCI15106 | Up to 51 days | PCI ranges for the clinical chemistry parameters were as follows: albumin (low: \<30 millimole per liter \[mmol/L\]), calcium (low: \<2 mmol/L and high: \>2.75 mmol/L), glucose (low: \<3 mmol/L and high: \>9 mmol/L), potassium (low: \<3 mmol/L and high: \>5.5 mmol/L) and sodium (low: \<130 mmol/L and high: \>150 mmol/L). Data for the participants with high and low values has been reported. |
| Part 1: Number of Participants With Clinical Chemistry Values of PCI in Bystanders | Up to 46 days | PCI ranges for the clinical chemistry parameters were as follows: albumin (low: \<30 mmol/L), calcium (low: \<2 mmol/L and high: \>2.75 mmol/L), glucose (low: \<3 mmol/L and high: \>9 mmol/L), potassium (low: \<3 mmol/L and high: \>5.5 mmol/L) and sodium (low: \<130 mmol/L and high: \>150 mmol/L). Data for the participants with high and low values has been reported. |
| Part 2: Number of Participants With Clinical Chemistry Values of PCI | Up to 46 days | PCI ranges for the clinical chemistry parameters were as follows: albumin (low: \<30 mmol/L), calcium (low: \<2 mmol/L and high: \>2.75 mmol/L), glucose (low: \<3 mmol/L and high: \>9 mmol/L), potassium (low: \<3 mmol/L and high: \>5.5 mmol/L) and sodium (low: \<130 mmol/L and high: \>150 mmol/L). Data for the participants with high and low values has been reported. |
| Part 1 Cohort A: Potential of Hydrogen (pH) Value by Visit- CCI15106 60 mg SD | Baseline (Day -1) and Day 2 | Urine samples were collected from participants at indicated time points for analysis of pH. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). |
| Part 1 Cohort A: pH Value by Visit- CCI15106 120 mg SD | Day 5 | Urine sample was collected from participants at indicated time point for analysis of pH. |
| Part 1 Cohort A: pH Value by Visit- CCI15106 30 mg BID | Days 12 and 22 | Urine samples were collected from participants at indicated time points for analysis of pH. |
| Part 1 Cohort B: pH Value by Visit- CCI15106 60 mg BID | Baseline (Day -1), Days 7 and 15 | Urine samples were collected from participants at indicated time points for analysis of pH. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). |
| Part 1: pH Value by Visit- Placebo | Baseline (Day -1), Days 2, 5, 7, 12, 15 and 22 | Urine samples were collected from participants at indicated time points for analysis of pH. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). |
| Part 1 Cohort C: pH Value by Visit- CCI15106 in Bystanders | Baseline (Day -1), Days 7 and 15 | Urine samples were collected from participants at indicated time points for analysis of pH. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). |
| Part 2 Cohort A: pH Value by Visit- CCI15106 | Baseline (Day -1) and Day 2 | Urine samples were collected from participants at indicated time points for analysis of pH. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). |
| Part 2 Cohort B: pH Value by Visit- CCI15106 60 mg BID | Baseline (Day -1), Days 7 and 15 | Urine samples were collected from participants at indicated time points for analysis of pH. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). |
| Part 1 Cohort A: Specific Gravity Value by Visit- CCI15106 60 mg SD | Baseline (Day -1) and Day 2 | Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected from participants at indicated time points for analysis of specific gravity. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). |
| Part 1 Cohort A: Specific Gravity Value by Visit- CCI15106 120 mg SD | Day 5 | Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine sample was collected from participants at indicated time point for analysis of specific gravity. |
| Part 1 Cohort A: Specific Gravity Value by Visit- CCI15106 30 mg BID | Days 12 and 22 | Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected from participants at indicated time points for analysis of specific gravity. |
| Part 1 Cohort B: Specific Gravity Value by Visit- CCI15106 60 mg BID | Baseline (Day -1), Days 7 and 15 | Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected from participants at indicated time points for analysis of Specific gravity. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). |
| Part 1: Specific Gravity Value by Visit- Placebo | Baseline (Day -1), Days 2, 5, 7, 12, 15 and 22 | Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected from participants at indicated time points for analysis of Specific gravity. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). |
| Part 1 Cohort C: Specific Gravity Value by Visit- CCI15106 in Bystanders | Baseline (Day -1), Days 7 and 15 | Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected from participants at indicated time points for analysis of specific gravity. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). |
| Part 2 Cohort A: Specific Gravity Value by Visit- CCI15106 | Baseline (Day -1) and Day 2 | Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected from participants at indicated time points for analysis of specific gravity. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). |
| Part 2 Cohort B: Specific Gravity Value by Visit- CCI15106 60 mg BID | Baseline (Day -1), Days 7 and 15 | Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected from participants at indicated time points for analysis of specific gravity. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). |
| Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106 | Up to 51 days | PCI ranges for the ECG parameters were as follows: absolute QTc interval \>450 and \<480, \>=480 and \<500, \>=500 milliseconds (msec), absolute PR interval \<110 and \>220 msec and absolute QRS interval \<75 and \>110 msec. QTcF=Frederica's QT interval corrected for heart rate; QTcB=Bazett's QT interval corrected for heart rate. Data for worst case post-Baseline has been reported. |
| Part 1: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI in Bystander | Up to 46 days | PCI ranges for the ECG parameters were as follows: absolute QTc interval \>450 and \<480, \>=480 and \<500, \>=500 msec, absolute PR interval \<110 and \>220 msec and absolute QRS interval \<75 and \>110 msec. Data for worst case post-Baseline has been reported. |
| Part 2: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI | Up to 46 days | PCI ranges for the ECG parameters were as follows: absolute QTc interval \>450 and \<480, \>=480 and \<500, \>=500 msec, absolute PR interval \<110 and \>220 msec and absolute QRS interval \<75 and \>110 msec. Data for worst case post-Baseline has been reported. |
| Part 1: Number of Participants With Abnormal Telemetry Findings | Days 1, 3, 6, 7, 12 and 18: 0.5 hour (pre-dose) to 4 hours post-dose | Continuous cardiac telemetry was performed from approximately 0.5 hour (pre-dose) to 4 hours post-dose. Abnormal findings were categorized as clinically significant (CS) and not clinically significant (NCS). 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. |
| Part 2: Number of Participants With Abnormal Telemetry Findings | Days 1, 7, 12 and 13: 0.5 hour (pre-dose) to 4 hours post-dose | Continuous cardiac telemetry was performed from approximately 0.5 hour (pre-dose) to 4 hours post-dose. Abnormal findings were categorized as CS and NCS. 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. |
| Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points | Days 1, 3, 6 and 19: pre-dose, 0.25, 0.5, 1 and 4 hours post-dose; Days 8, 11 and 16: pre-dose and 4 hours post-dose; Day 14: pre-dose, 0.5, 1 and 4 hours post-dose | FEV1 is a measure of lung function and the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured using standard spirometry. Percent predicted FEV1 was calculated as: Percent predicted FEV1=(maximum FEV1 divided by predicted normal FEV1)\*100. |
| Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points | Days 1, 3, 6 and 19: pre-dose, 0.25, 0.5, 1 and 4 hours post-dose; Days 8, 11 and 16: pre-dose and 4 hours post-dose; Day 14: pre-dose, 0.5, 1 and 4 hours post-dose | FVC is a measure of lung function and the maximal amount of air that can be forcefully exhaled in one second. FVC was measured using standard spirometry. Percent predicted FVC was calculated as: Percent predicted FVC=(maximum FVC divided by predicted normal FVC)\*100. |
| Part 2: Percent Predicted FEV1 at Indicated Time Points | Day 1 and 14: pre-dose, 0.25, 0.5, 1 and 4 hours post-dose; Days 3, 6 and 11: pre-dose and 4 hours post-dose | FEV1 is a measure of lung function and the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured using standard spirometry. Percent predicted FEV1 was calculated as: Percent predicted FEV1=(maximum FEV1 divided by predicted normal FEV1)\*100. |
| Part 2: Percent Predicted FVC at Indicated Time Points | Day 1 and 14: pre-dose, 0.25, 0.5, 1 and 4 hours post-dose; Days 3, 6 and 11: pre-dose and 4 hours post-dose | FVC is a measure of lung function and the maximal amount of air that can be forcefully exhaled in one second. FVC was measured using standard spirometry. Percent predicted FVC was calculated as: Percent predicted FVC=(maximum FVC divided by predicted normal FVC)\*100. |
| Part 1: Number of Participants With Vital Signs Values of PCI | Up to 51 days | PCI ranges for the vital signs parameters were as follows: systolic blood pressure (SBP) \<85 and \>160 millimeters of mercury (mmHg), diastolic blood pressure (DBP) \<45 and \>100 mmHg and heart rate \<40 and \>110 beats per minute (bpm). Data for the participants with high and low values has been reported. |
| Part 1: Number of Participants With Vital Signs Values of PCI in Bystanders | Up to 46 days | PCI ranges for the vital signs parameters were as follows: SBP \<85 and \>160 mmHg, DBP \<45 and \>100 mmHg and heart rate \<40 and \>110 bpm. Data for the participants with high and low values has been reported. |
| Part 2: Number of Participants With Vital Signs Values of PCI | Up to 46 days | PCI ranges for the vital signs parameters were as follows: SBP \<85 and \>160 mmHg, DBP \<45 and \>100 mmHg and heart rate \<40 and \>110 bpm. Data for the participants with high and low values has been reported. |
| Part 1 Cohort A: Area Under the Curve (AUC) From Time Zero to the Time of Last Quantifiable Concentration (AUC[0-t]) After Single Dose Administration of CCI15106 60 mg on Day 1 | Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 and 48 hours post-dose | Blood samples were collected to evaluate the pharmacokinetics (PKs) of CCI15106 at the indicated time points on Day 1 for the analysis of AUC(0-t) data. PK population consisted of participants who received at least one dose of study treatment and who undergo plasma PK sampling and had at least one post-dose concentration result. |
| Part 1 Cohort A: AUC(0-t) After Single Dose Administration of CCI15106 120 mg on Day 3 | Day 3: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose | Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 3 for the analysis of AUC(0-t) data. |
| Part 2 Cohort A: AUC(0-t) After Single Dose Administration of CCI15106 60 mg on Day 1 | Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose | Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of AUC(0-t) data. |
| Part 1 Cohort A: Maximum Observed Plasma Concentration (Cmax) After Single Dose Administration of CCI15106 60 mg on Day 1 | Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 and 48 hours post-dose | Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of Cmax data. |
| Part 1 Cohort A: Cmax After Single Dose Administration of CCI15106 120 mg on Day 3 | Day 3: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose | Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 3 for the analysis of Cmax data. |
| Part 2 Cohort A: Cmax After Single Dose Administration of CCI15106 60 mg on Day 1 | Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose | Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of Cmax data. |
| Part 1 Cohort A: Time of Maximum Concentration (Tmax) After Single Dose Administration of CCI15106 60 mg on Day 1 | Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 and 48 hours post-dose | Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of tmax data. |
| Part 1 Cohort A: Tmax After Single Dose Administration of CCI15106 120 mg on Day 3 | Day 3: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose | Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 3 for the analysis of tmax data. |
| Part 2 Cohort A: Tmax After Single Dose Administration of CCI15106 60 mg on Day 1 | Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose | Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of tmax data. |
| Part 1 Cohort A: AUC From Time Zero to Infinity (AUC[0-infinity]) After Single Dose Administration of CCI15106 60 mg on Day 1 | Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 and 48 hours post-dose | Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of AUC(0-infinity) data. |
| Part 1 Cohort A: AUC(0-infinity) After Single Dose Administration of CCI15106 120 mg on Day 3 | Day 3: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose | Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 3 for the analysis of AUC(0-infinity) data. |
| Part 2 Cohort A: AUC(0-infinity) After Single Dose Administration of CCI15106 60 mg on Day 1 | Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose | Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of AUC(0-infinity) data. |
| Part 1 Cohort A: Elimination Half-life (t1/2) After Single Dose Administration of CCI15106 60 mg on Day 1 | Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 and 48 hours post-dose | Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of t1/2 data. |
| Part 1 Cohort A: t1/2 After Single Dose Administration of CCI15106 120 mg on Day 3 | Day 3: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose | Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 3 for the analysis of t1/2 data. |
| Part 2 Cohort A: t1/2 After Single Dose Administration of CCI15106 60 mg on Day 1 | Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose | Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of t1/2 data. |
| Part 1 Cohort A: Clearance (CL/F) After Single Dose Administration of CCI15106 60 mg on Day 1 | Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 and 48 hours post-dose | Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of CL/F data. |
| Part 1 Cohort A: CL/F After Single Dose Administration of CCI15106 120 mg on Day 3 | Day 3: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose | Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 3 for the analysis of CL/F data. |
| Part 2 Cohort A: CL/F After Single Dose Administration of CCI15106 60 mg on Day 1 | Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose | Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of CL/F data. |
| Part 1 Cohort A: AUC From Time Zero to End of Dosing Interval (AUC[0-tau]) After Repeated Dose Administration of CCI15106 30 mg | Day 6: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day 19: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose | Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 6 and 19 for the analysis of AUC(0-tau) data. |
| Part 1 Cohort B: AUC(0-tau) After Repeated Dose Administration of CCI15106 60 mg | Days 1 and 14: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose | Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of AUC(0-tau) data. |
| Part 2 Cohort B: AUC(0-tau) After Repeated Dose Administration of CCI15106 60 mg | Days 1 and 14: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose | Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of AUC(0-tau) data. |
| Part 1 Cohort A: Cmax After Repeated Dose Administration of CCI15106 30 mg | Day 6: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day 19: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose | Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 6 and 19 for the analysis of Cmax data. |
| Part 1 Cohort B: Cmax After Repeated Dose Administration of CCI15106 60 mg | Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day 14: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose | Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of Cmax data. |
| Part 2 Cohort B: Cmax After Repeated Dose Administration of CCI15106 60 mg | Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day14: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose | Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of Cmax data. |
| Part 1 Cohort A: Tmax After Repeated Dose Administration of CCI15106 30 mg | Day 6: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day 19: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose | Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 6 and 19 for the analysis of tmax data. |
| Part 1 Cohort B: Tmax After Repeated Dose Administration of CCI15106 60 mg | Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day 14: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose | Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of tmax data. |
| Part 2 Cohort B: Tmax After Repeated Dose Administration of CCI15106 60 mg | Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day14: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose | Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of tmax data. |
| Part 1 Cohort A: t1/2 After Repeated Dose Administration of CCI15106 30 mg | Day 6: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day 19: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose | Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 6 and 19 for the analysis of t1/2 data. |
| Part 1 Cohort B: t1/2 After Repeated Dose Administration of CCI15106 60 mg | Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day 14: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose | Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of t1/2 data. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part 2: Concentration of CCI15106 in ELF in Repeated Dose of Cohort B 60 mg | Up to Day 13 | BAL samples for ELF concentration analysis of CCI15106 were collected up to Day 13. |
| Part 1: Number of Participants With Medical Device Incidents in CCI15106 | Up to Day 19 | A medical device incident is any malfunction or deterioration in the characteristics and/or performance of a device as well as any inadequacy in the labeling or the instructions for use which, directly or indirectly, might lead to or might have led to the death of a participant/user/other person or to a serious deterioration in his/her state of health. |
| Part 1: Concentration of CCI15106 in Lung Epithelial Lining Fluid (ELF) in Repeated Dose of Cohort B 60 mg | Up to Day 13 | Bronchoalveolar lavage samples for ELF concentration analysis of CCI15106 were collected up to Day 13. Participants who received at least one dose of study treatment and who underwent bronchoalveolar lavage (BAL) sampling and had post-dose lung ELF CCI15106 and urea concentration result were included in BAL PK Population. |
Countries
United Kingdom
Participant flow
Recruitment details
This was a two parts single and repeat dose escalation study. Part 1 was conducted in healthy volunteers and Part 2 was conducted in participants with moderate chronic obstructive pulmonary disease (COPD).
Pre-assignment details
A total of 52 participants (36 in Part 1 and 16 in Part 2) were enrolled in this study. This study was conducted at a single center in the United Kingdom from 13-July-2017 to 19-June-2018.
Participants by arm
| Arm | Count |
|---|---|
| Part 1: Cohort A- CCI15106 Healthy participants were administered a SD dose of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01, followed by a SD dose of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01, further followed by a BID dose of CCI15106 30 mg by inhalation route on Days 6 to 19 via Monodose RS01. | 6 |
| Part 1: Cohort A- Placebo Healthy participants were administered a SD dose of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01, followed by a SD dose of matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01, further followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01. | 2 |
| Part 1: Cohort B- CCI15106 60 mg BID Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01. | 12 |
| Part 1: Cohort B- Placebo Healthy participants were administered with a BID dose of matching placebo 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B. | 2 |
| Part 1: Cohort C- Bystanders Healthy participants were enrolled to evaluate bystander exposure and evaluated concomitantly with Cohort B. Bystanders reported to the unit on Day -1 and remained for 14 days of dosing of Cohort B. | 14 |
| Part 2: Cohort A- CCI15106 60 mg SD Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01. | 6 |
| Part 2: Cohort A- Placebo Participants with COPD received a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01 in Cohort A. | 2 |
| Part 2: Cohort B- CCI15106 60 mg BID Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01. | 8 |
| Total | 52 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Part 1 (Cohort B and C- Days 1 to 14) | Drug was prematurely discontinued | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Part 1 (Cohort B and C- Days 1 to 14) | Withdrawal by Subject | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Total | Part 1: Cohort A- Placebo | Part 1: Cohort A- CCI15106 | Part 1: Cohort B- CCI15106 60 mg BID | Part 1: Cohort B- Placebo | Part 1: Cohort C- Bystanders | Part 2: Cohort A- CCI15106 60 mg SD | Part 2: Cohort A- Placebo | Part 2: Cohort B- CCI15106 60 mg BID |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 7 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 1 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 45 Participants | 2 Participants | 6 Participants | 12 Participants | 2 Participants | 14 Participants | 4 Participants | 1 Participants | 4 Participants |
| Race/Ethnicity, Customized Black or African American | 6 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 3 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Black or African American and Asian | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Black or African American and White | 2 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized White-White/Caucasian/European | 43 Participants | 2 Participants | 5 Participants | 10 Participants | 1 Participants | 9 Participants | 6 Participants | 2 Participants | 8 Participants |
| Sex: Female, Male Female | 5 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants | 0 Participants | 2 Participants |
| Sex: Female, Male Male | 47 Participants | 2 Participants | 6 Participants | 12 Participants | 2 Participants | 13 Participants | 4 Participants | 2 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 2 | 0 / 12 | 0 / 2 | 0 / 14 | 0 / 6 | 0 / 2 | 0 / 8 |
| other Total, other adverse events | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 2 | 6 / 12 | 0 / 2 | 6 / 14 | 0 / 6 | 0 / 2 | 7 / 8 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 2 | 0 / 12 | 0 / 2 | 0 / 14 | 0 / 6 | 0 / 2 | 0 / 8 |
Outcome results
Primary
Part 1 Cohort A: Area Under the Curve (AUC) From Time Zero to the Time of Last Quantifiable Concentration (AUC[0-t]) After Single Dose Administration of CCI15106 60 mg on Day 1
Blood samples were collected to evaluate the pharmacokinetics (PKs) of CCI15106 at the indicated time points on Day 1 for the analysis of AUC(0-t) data. PK population consisted of participants who received at least one dose of study treatment and who undergo plasma PK sampling and had at least one post-dose concentration result.
Time frame: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 and 48 hours post-dose
Population: PK Population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1 Cohort A: Area Under the Curve (AUC) From Time Zero to the Time of Last Quantifiable Concentration (AUC[0-t]) After Single Dose Administration of CCI15106 60 mg on Day 1 | 1255.3711 Hours*nanogram per milliliter | Geometric Coefficient of Variation 19.4 |
Primary
Part 1 Cohort A: AUC(0-infinity) After Single Dose Administration of CCI15106 120 mg on Day 3
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 3 for the analysis of AUC(0-infinity) data.
Time frame: Day 3: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose
Population: PK Population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1 Cohort A: AUC(0-infinity) After Single Dose Administration of CCI15106 120 mg on Day 3 | 4418.9437 Hours*nanogram per milliliter | Geometric Coefficient of Variation 37.7 |
Primary
Part 1 Cohort A: AUC(0-t) After Single Dose Administration of CCI15106 120 mg on Day 3
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 3 for the analysis of AUC(0-t) data.
Time frame: Day 3: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose
Population: PK Population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1 Cohort A: AUC(0-t) After Single Dose Administration of CCI15106 120 mg on Day 3 | 3256.6746 Hours*nanogram per milliliter | Geometric Coefficient of Variation 29.7 |
Primary
Part 1 Cohort A: AUC From Time Zero to End of Dosing Interval (AUC[0-tau]) After Repeated Dose Administration of CCI15106 30 mg
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 6 and 19 for the analysis of AUC(0-tau) data.
Time frame: Day 6: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day 19: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose
Population: PK Population. NA indicates that, AUC(0-tau) could not be calculated because t1/2 considered unreliable as period over which they were calculated was less than twice resultant t1/2 in all cases. In addition, percent AUCextrapolated (%AUCex) was \>20% in most cases. This was largely due to short period of sampling times.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1 Cohort A: AUC From Time Zero to End of Dosing Interval (AUC[0-tau]) After Repeated Dose Administration of CCI15106 30 mg | Day 6 | NA Hours*nanogram per milliliter | — |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1 Cohort A: AUC From Time Zero to End of Dosing Interval (AUC[0-tau]) After Repeated Dose Administration of CCI15106 30 mg | Day 19 | 1214.2671 Hours*nanogram per milliliter | Geometric Coefficient of Variation 21.1 |
Primary
Part 1 Cohort A: AUC From Time Zero to Infinity (AUC[0-infinity]) After Single Dose Administration of CCI15106 60 mg on Day 1
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of AUC(0-infinity) data.
Time frame: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 and 48 hours post-dose
Population: PK Population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1 Cohort A: AUC From Time Zero to Infinity (AUC[0-infinity]) After Single Dose Administration of CCI15106 60 mg on Day 1 | 1618.4216 Hours*nanogram per milliliter | Geometric Coefficient of Variation 20.6 |
Primary
Part 1 Cohort A: Clearance (CL/F) After Single Dose Administration of CCI15106 60 mg on Day 1
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of CL/F data.
Time frame: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 and 48 hours post-dose
Population: PK Population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1 Cohort A: Clearance (CL/F) After Single Dose Administration of CCI15106 60 mg on Day 1 | 37.0732 Liters per hour | Geometric Coefficient of Variation 20.6 |
Primary
Part 1 Cohort A: CL/F After Single Dose Administration of CCI15106 120 mg on Day 3
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 3 for the analysis of CL/F data.
Time frame: Day 3: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose
Population: PK Population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1 Cohort A: CL/F After Single Dose Administration of CCI15106 120 mg on Day 3 | 27.1558 Liters per hour | Geometric Coefficient of Variation 37.7 |
Primary
Part 1 Cohort A: Cmax After Repeated Dose Administration of CCI15106 30 mg
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 6 and 19 for the analysis of Cmax data.
Time frame: Day 6: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day 19: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose
Population: PK Population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1 Cohort A: Cmax After Repeated Dose Administration of CCI15106 30 mg | Day 19 | 193.9 Nanogram per milliliter | Geometric Coefficient of Variation 15.1 |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1 Cohort A: Cmax After Repeated Dose Administration of CCI15106 30 mg | Day 6 | 143.1 Nanogram per milliliter | Geometric Coefficient of Variation 23.2 |
Primary
Part 1 Cohort A: Cmax After Single Dose Administration of CCI15106 120 mg on Day 3
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 3 for the analysis of Cmax data.
Time frame: Day 3: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose
Population: PK Population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1 Cohort A: Cmax After Single Dose Administration of CCI15106 120 mg on Day 3 | 507.6 Nanogram per milliliter | Geometric Coefficient of Variation 27.6 |
Primary
Part 1 Cohort A: Elimination Half-life (t1/2) After Single Dose Administration of CCI15106 60 mg on Day 1
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of t1/2 data.
Time frame: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 and 48 hours post-dose
Population: PK Population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1 Cohort A: Elimination Half-life (t1/2) After Single Dose Administration of CCI15106 60 mg on Day 1 | 25.8346 Hours | Geometric Coefficient of Variation 5.1 |
Primary
Part 1 Cohort A: Maximum Observed Plasma Concentration (Cmax) After Single Dose Administration of CCI15106 60 mg on Day 1
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of Cmax data.
Time frame: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 and 48 hours post-dose
Population: PK Population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1 Cohort A: Maximum Observed Plasma Concentration (Cmax) After Single Dose Administration of CCI15106 60 mg on Day 1 | 232.2 Nanogram per milliliter | Geometric Coefficient of Variation 20.2 |
Primary
Part 1 Cohort A: Number of Participants With Non-serious Adverse Events (NSAEs) and Serious Adverse Events (SAEs) in CCI15106
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is 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. Safety population comprised of all participants who received at least one dose of study treatment during the study.
Time frame: Up to 51 days
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1 Cohort A: Number of Participants With Non-serious Adverse Events (NSAEs) and Serious Adverse Events (SAEs) in CCI15106 | NSAEs | 0 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1 Cohort A: Number of Participants With Non-serious Adverse Events (NSAEs) and Serious Adverse Events (SAEs) in CCI15106 | SAEs | 0 Participants |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 1 Cohort A: Number of Participants With Non-serious Adverse Events (NSAEs) and Serious Adverse Events (SAEs) in CCI15106 | SAEs | 0 Participants |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 1 Cohort A: Number of Participants With Non-serious Adverse Events (NSAEs) and Serious Adverse Events (SAEs) in CCI15106 | NSAEs | 0 Participants |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 1 Cohort A: Number of Participants With Non-serious Adverse Events (NSAEs) and Serious Adverse Events (SAEs) in CCI15106 | NSAEs | 0 Participants |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 1 Cohort A: Number of Participants With Non-serious Adverse Events (NSAEs) and Serious Adverse Events (SAEs) in CCI15106 | SAEs | 0 Participants |
| Part 1: Cohort A- Placebo | Part 1 Cohort A: Number of Participants With Non-serious Adverse Events (NSAEs) and Serious Adverse Events (SAEs) in CCI15106 | NSAEs | 0 Participants |
| Part 1: Cohort A- Placebo | Part 1 Cohort A: Number of Participants With Non-serious Adverse Events (NSAEs) and Serious Adverse Events (SAEs) in CCI15106 | SAEs | 0 Participants |
Primary
Part 1 Cohort A: pH Value by Visit- CCI15106 120 mg SD
Urine sample was collected from participants at indicated time point for analysis of pH.
Time frame: Day 5
Population: Safety Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1 Cohort A: pH Value by Visit- CCI15106 120 mg SD | 6.58 pH | Standard Deviation 0.736 |
Primary
Part 1 Cohort A: pH Value by Visit- CCI15106 30 mg BID
Urine samples were collected from participants at indicated time points for analysis of pH.
Time frame: Days 12 and 22
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1 Cohort A: pH Value by Visit- CCI15106 30 mg BID | Day 12 | 6.50 pH | Standard Deviation 0.949 |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1 Cohort A: pH Value by Visit- CCI15106 30 mg BID | Day 22 | 6.92 pH | Standard Deviation 0.665 |
Primary
Part 1 Cohort A: Potential of Hydrogen (pH) Value by Visit- CCI15106 60 mg SD
Urine samples were collected from participants at indicated time points for analysis of pH. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).
Time frame: Baseline (Day -1) and Day 2
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1 Cohort A: Potential of Hydrogen (pH) Value by Visit- CCI15106 60 mg SD | Baseline | 6.00 pH | Standard Deviation 0 |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1 Cohort A: Potential of Hydrogen (pH) Value by Visit- CCI15106 60 mg SD | Day 2 | 6.33 pH | Standard Deviation 0.816 |
Primary
Part 1 Cohort A: Specific Gravity Value by Visit- CCI15106 120 mg SD
Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine sample was collected from participants at indicated time point for analysis of specific gravity.
Time frame: Day 5
Population: Safety Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1 Cohort A: Specific Gravity Value by Visit- CCI15106 120 mg SD | 1.0182 Ratio | Standard Deviation 0.00722 |
Primary
Part 1 Cohort A: Specific Gravity Value by Visit- CCI15106 30 mg BID
Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected from participants at indicated time points for analysis of specific gravity.
Time frame: Days 12 and 22
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1 Cohort A: Specific Gravity Value by Visit- CCI15106 30 mg BID | Day 12 | 1.0115 Ratio | Standard Deviation 0.00442 |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1 Cohort A: Specific Gravity Value by Visit- CCI15106 30 mg BID | Day 22 | 1.0115 Ratio | Standard Deviation 0.00442 |
Primary
Part 1 Cohort A: Specific Gravity Value by Visit- CCI15106 60 mg SD
Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected from participants at indicated time points for analysis of specific gravity. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).
Time frame: Baseline (Day -1) and Day 2
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1 Cohort A: Specific Gravity Value by Visit- CCI15106 60 mg SD | Baseline | 1.0217 Ratio | Standard Deviation 0.01033 |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1 Cohort A: Specific Gravity Value by Visit- CCI15106 60 mg SD | Day 2 | 1.0105 Ratio | Standard Deviation 0.00625 |
Primary
Part 1 Cohort A: t1/2 After Repeated Dose Administration of CCI15106 30 mg
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 6 and 19 for the analysis of t1/2 data.
Time frame: Day 6: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day 19: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose
Population: PK Population. NA indicates that, t1/2 of CCI15106 plasma concentration in healthy participant was estimated but considered unreliable as period over which they were calculated was less than twice resultant t1/2 in all cases. In addition, %AUCex was \>20% in most cases. This was largely due to short period of sampling times.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1 Cohort A: t1/2 After Repeated Dose Administration of CCI15106 30 mg | Day 6 | NA Hours | — |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1 Cohort A: t1/2 After Repeated Dose Administration of CCI15106 30 mg | Day 19 | 18.1484 Hours | Geometric Coefficient of Variation 10.2 |
Primary
Part 1 Cohort A: t1/2 After Single Dose Administration of CCI15106 120 mg on Day 3
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 3 for the analysis of t1/2 data.
Time frame: Day 3: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose
Population: PK Population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1 Cohort A: t1/2 After Single Dose Administration of CCI15106 120 mg on Day 3 | 41.2596 Hours | Geometric Coefficient of Variation 32 |
Primary
Part 1 Cohort A: Time of Maximum Concentration (Tmax) After Single Dose Administration of CCI15106 60 mg on Day 1
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of tmax data.
Time frame: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 and 48 hours post-dose
Population: PK Population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1 Cohort A: Time of Maximum Concentration (Tmax) After Single Dose Administration of CCI15106 60 mg on Day 1 | 0.500 Hours |
Primary
Part 1 Cohort A: Tmax After Repeated Dose Administration of CCI15106 30 mg
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 6 and 19 for the analysis of tmax data.
Time frame: Day 6: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day 19: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose
Population: PK Population.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1 Cohort A: Tmax After Repeated Dose Administration of CCI15106 30 mg | Day 6 | 0.500 Hours |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1 Cohort A: Tmax After Repeated Dose Administration of CCI15106 30 mg | Day 19 | 0.500 Hours |
Primary
Part 1 Cohort A: Tmax After Single Dose Administration of CCI15106 120 mg on Day 3
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 3 for the analysis of tmax data.
Time frame: Day 3: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose
Population: PK Population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1 Cohort A: Tmax After Single Dose Administration of CCI15106 120 mg on Day 3 | 0.625 Hours |
Primary
Part 1 Cohort B: AUC(0-tau) After Repeated Dose Administration of CCI15106 60 mg
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of AUC(0-tau) data.
Time frame: Days 1 and 14: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose
Population: PK Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1 Cohort B: AUC(0-tau) After Repeated Dose Administration of CCI15106 60 mg | Day 1, n=12 | 564.7314 Hours*nanogram per milliliter | Geometric Coefficient of Variation 50.2 |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1 Cohort B: AUC(0-tau) After Repeated Dose Administration of CCI15106 60 mg | Day 14, n=8 | 2059.8983 Hours*nanogram per milliliter | Geometric Coefficient of Variation 15.2 |
Primary
Part 1 Cohort B: Cmax After Repeated Dose Administration of CCI15106 60 mg
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of Cmax data.
Time frame: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day 14: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose
Population: PK Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1 Cohort B: Cmax After Repeated Dose Administration of CCI15106 60 mg | Day 1, n=12 | 188.7 Nanogram per milliliter | Geometric Coefficient of Variation 63.5 |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1 Cohort B: Cmax After Repeated Dose Administration of CCI15106 60 mg | Day 14, n=11 | 285.0 Nanogram per milliliter | Geometric Coefficient of Variation 39 |
Primary
Part 1 Cohort B: Number of Participants With NSAEs and SAEs in CCI15106
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is 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.
Time frame: Up to 46 days
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1 Cohort B: Number of Participants With NSAEs and SAEs in CCI15106 | NSAEs | 6 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1 Cohort B: Number of Participants With NSAEs and SAEs in CCI15106 | SAEs | 0 Participants |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 1 Cohort B: Number of Participants With NSAEs and SAEs in CCI15106 | NSAEs | 0 Participants |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 1 Cohort B: Number of Participants With NSAEs and SAEs in CCI15106 | SAEs | 0 Participants |
Primary
Part 1 Cohort B: pH Value by Visit- CCI15106 60 mg BID
Urine samples were collected from participants at indicated time points for analysis of pH. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).
Time frame: Baseline (Day -1), Days 7 and 15
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1 Cohort B: pH Value by Visit- CCI15106 60 mg BID | Baseline | 6.21 pH | Standard Deviation 0.811 |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1 Cohort B: pH Value by Visit- CCI15106 60 mg BID | Day 7 | 6.63 pH | Standard Deviation 0.882 |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1 Cohort B: pH Value by Visit- CCI15106 60 mg BID | Day 15 | 6.21 pH | Standard Deviation 0.62 |
Primary
Part 1 Cohort B: Specific Gravity Value by Visit- CCI15106 60 mg BID
Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected from participants at indicated time points for analysis of Specific gravity. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).
Time frame: Baseline (Day -1), Days 7 and 15
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1 Cohort B: Specific Gravity Value by Visit- CCI15106 60 mg BID | Baseline | 1.0136 Ratio | Standard Deviation 0.00734 |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1 Cohort B: Specific Gravity Value by Visit- CCI15106 60 mg BID | Day 7 | 1.0152 Ratio | Standard Deviation 0.01039 |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1 Cohort B: Specific Gravity Value by Visit- CCI15106 60 mg BID | Day 15 | 1.0167 Ratio | Standard Deviation 0.00444 |
Primary
Part 1 Cohort B: t1/2 After Repeated Dose Administration of CCI15106 60 mg
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of t1/2 data.
Time frame: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day 14: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose
Population: PK Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1 Cohort B: t1/2 After Repeated Dose Administration of CCI15106 60 mg | Day 1, n=12 | 8.3719 Hours | Geometric Coefficient of Variation 14.2 |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1 Cohort B: t1/2 After Repeated Dose Administration of CCI15106 60 mg | Day 14, n=8 | 23.0497 Hours | Geometric Coefficient of Variation 42.4 |
Primary
Part 1 Cohort B: Tmax After Repeated Dose Administration of CCI15106 60 mg
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of tmax data.
Time frame: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day 14: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose
Population: PK Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1 Cohort B: Tmax After Repeated Dose Administration of CCI15106 60 mg | Day 1, n=12 | 0.633 Hours |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1 Cohort B: Tmax After Repeated Dose Administration of CCI15106 60 mg | Day 14, n=11 | 0.500 Hours |
Primary
Part 1 Cohort C: Number of Participants With NSAEs and SAEs in Bystanders
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is 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.
Time frame: Up to 46 days
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1 Cohort C: Number of Participants With NSAEs and SAEs in Bystanders | NSAEs | 6 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1 Cohort C: Number of Participants With NSAEs and SAEs in Bystanders | SAEs | 0 Participants |
Primary
Part 1 Cohort C: pH Value by Visit- CCI15106 in Bystanders
Urine samples were collected from participants at indicated time points for analysis of pH. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).
Time frame: Baseline (Day -1), Days 7 and 15
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1 Cohort C: pH Value by Visit- CCI15106 in Bystanders | Baseline | 6.36 pH | Standard Deviation 0.633 |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1 Cohort C: pH Value by Visit- CCI15106 in Bystanders | Day 7 | 6.36 pH | Standard Deviation 0.719 |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1 Cohort C: pH Value by Visit- CCI15106 in Bystanders | Day 15 | 5.96 pH | Standard Deviation 0.499 |
Primary
Part 1 Cohort C: Specific Gravity Value by Visit- CCI15106 in Bystanders
Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected from participants at indicated time points for analysis of specific gravity. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).
Time frame: Baseline (Day -1), Days 7 and 15
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1 Cohort C: Specific Gravity Value by Visit- CCI15106 in Bystanders | Day 7 | 1.0163 Ratio | Standard Deviation 0.00907 |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1 Cohort C: Specific Gravity Value by Visit- CCI15106 in Bystanders | Baseline | 1.0191 Ratio | Standard Deviation 0.01339 |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1 Cohort C: Specific Gravity Value by Visit- CCI15106 in Bystanders | Day 15 | 1.0182 Ratio | Standard Deviation 0.0075 |
Primary
Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Bystander: Cohort C
Personal exposure air samples were collected on filters placed on each bystander after the first daily dose at indicated time points. The filters were used to measure CCI15106 concentration in the person's breathing zone. Fixed location concentrations were measured near window, near door, back to wall and facing wall in the dosing room over 15 minutes post-dose. Each bystander had a filter attached to their study clothing. The filters were measured for CCI15106. This was a single measurement from the filter for each bystsander. The locations (near window, near door, back to wall and facing wall) were just to record where the bystander was located in the room.
Time frame: Days 1, 7 and 14: 15 minutes post-dose
Population: Bystander PK Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Bystander: Cohort C | Day 7: Near door,n=1,1,1,1,0,0,0 | 2.81 Microgram per cubic meter |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Bystander: Cohort C | Day 7: Near window,n=1,1,1,1,0,0,0 | 2.86 Microgram per cubic meter |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Bystander: Cohort C | Day 1: Near door,n=1,1,1,1,0,0,0 | 0.53 Microgram per cubic meter |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Bystander: Cohort C | Day 1: Near window,n=1,1,1,1,0,0,0 | 1.10 Microgram per cubic meter |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Bystander: Cohort C | Day 14: Near door,n=1,1,1,1,0,0,0 | 0.10 Microgram per cubic meter |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Bystander: Cohort C | Day 14: Near window,n=1,1,1,1,0,0,0 | 0.10 Microgram per cubic meter |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Bystander: Cohort C | Day 1: Near door,n=1,1,1,1,0,0,0 | 0.39 Microgram per cubic meter |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Bystander: Cohort C | Day 1: Near window,n=1,1,1,1,0,0,0 | 0.10 Microgram per cubic meter |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Bystander: Cohort C | Day 14: Near window,n=1,1,1,1,0,0,0 | 1.73 Microgram per cubic meter |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Bystander: Cohort C | Day 14: Near door,n=1,1,1,1,0,0,0 | 1.97 Microgram per cubic meter |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Bystander: Cohort C | Day 7: Near door,n=1,1,1,1,0,0,0 | 2.62 Microgram per cubic meter |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Bystander: Cohort C | Day 7: Near window,n=1,1,1,1,0,0,0 | 2.74 Microgram per cubic meter |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Bystander: Cohort C | Day 7: Near window,n=1,1,1,1,0,0,0 | 3.14 Microgram per cubic meter |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Bystander: Cohort C | Day 1: Near door,n=1,1,1,1,0,0,0 | 1.81 Microgram per cubic meter |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Bystander: Cohort C | Day 14: Near door,n=1,1,1,1,0,0,0 | 9.22 Microgram per cubic meter |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Bystander: Cohort C | Day 14: Near window,n=1,1,1,1,0,0,0 | 8.09 Microgram per cubic meter |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Bystander: Cohort C | Day 1: Near window,n=1,1,1,1,0,0,0 | 2.46 Microgram per cubic meter |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Bystander: Cohort C | Day 7: Near door,n=1,1,1,1,0,0,0 | 2.13 Microgram per cubic meter |
| Part 1: Cohort A- Placebo | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Bystander: Cohort C | Day 7: Near window,n=1,1,1,1,0,0,0 | 0.41 Microgram per cubic meter |
| Part 1: Cohort A- Placebo | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Bystander: Cohort C | Day 1: Near door,n=1,1,1,1,0,0,0 | 8.99 Microgram per cubic meter |
| Part 1: Cohort A- Placebo | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Bystander: Cohort C | Day 1: Near window,n=1,1,1,1,0,0,0 | 4.84 Microgram per cubic meter |
| Part 1: Cohort A- Placebo | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Bystander: Cohort C | Day 7: Near door,n=1,1,1,1,0,0,0 | 0.49 Microgram per cubic meter |
| Part 1: Cohort A- Placebo | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Bystander: Cohort C | Day 14: Near window,n=1,1,1,1,0,0,0 | 0.45 Microgram per cubic meter |
| Part 1: Cohort A- Placebo | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Bystander: Cohort C | Day 14: Near door,n=1,1,1,1,0,0,0 | 0.10 Microgram per cubic meter |
| Part 1: Placebo | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Bystander: Cohort C | Day 14: Back to wall,n=0,0,0,0,1,1,1 | 0.38 Microgram per cubic meter |
| Part 1: Placebo | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Bystander: Cohort C | Day 1: Back to wall,n=0,0,0,0,1,1,1 | 5.27 Microgram per cubic meter |
| Part 1: Placebo | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Bystander: Cohort C | Day 1: Facing wall,n=0,0,0,0,1,1,1 | 5.84 Microgram per cubic meter |
| Part 1: Placebo | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Bystander: Cohort C | Day 7: Back to wall,n=0,0,0,0,1,1,1 | 0.76 Microgram per cubic meter |
| Part 1: Placebo | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Bystander: Cohort C | Day 7: Facing wall,n=0,0,0,0,1,1,1 | 0.86 Microgram per cubic meter |
| Part 1: Placebo | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Bystander: Cohort C | Day 14: Facing wall,n=0,0,0,0,1,1,1 | 0.10 Microgram per cubic meter |
| Part 1: Bystander Group 4- Session 1 | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Bystander: Cohort C | Day 7: Facing wall,n=0,0,0,0,1,1,1 | 0.10 Microgram per cubic meter |
| Part 1: Bystander Group 4- Session 1 | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Bystander: Cohort C | Day 7: Back to wall,n=0,0,0,0,1,1,1 | 0.47 Microgram per cubic meter |
| Part 1: Bystander Group 4- Session 1 | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Bystander: Cohort C | Day 1: Facing wall,n=0,0,0,0,1,1,1 | 0.10 Microgram per cubic meter |
| Part 1: Bystander Group 4- Session 1 | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Bystander: Cohort C | Day 1: Back to wall,n=0,0,0,0,1,1,1 | 0.10 Microgram per cubic meter |
| Part 1: Bystander Group 4- Session 1 | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Bystander: Cohort C | Day 14: Back to wall,n=0,0,0,0,1,1,1 | 0.35 Microgram per cubic meter |
| Part 1: Bystander Group 4- Session 1 | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Bystander: Cohort C | Day 14: Facing wall,n=0,0,0,0,1,1,1 | 0.10 Microgram per cubic meter |
| Part 1: Bystander Group 4- Session 2 | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Bystander: Cohort C | Day 14: Facing wall,n=0,0,0,0,1,1,1 | 0.10 Microgram per cubic meter |
| Part 1: Bystander Group 4- Session 2 | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Bystander: Cohort C | Day 7: Back to wall,n=0,0,0,0,1,1,1 | 0.80 Microgram per cubic meter |
| Part 1: Bystander Group 4- Session 2 | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Bystander: Cohort C | Day 7: Facing wall,n=0,0,0,0,1,1,1 | 1.00 Microgram per cubic meter |
| Part 1: Bystander Group 4- Session 2 | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Bystander: Cohort C | Day 1: Facing wall,n=0,0,0,0,1,1,1 | 0.10 Microgram per cubic meter |
| Part 1: Bystander Group 4- Session 2 | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Bystander: Cohort C | Day 14: Back to wall,n=0,0,0,0,1,1,1 | 0.10 Microgram per cubic meter |
| Part 1: Bystander Group 4- Session 2 | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Bystander: Cohort C | Day 1: Back to wall,n=0,0,0,0,1,1,1 | 0.10 Microgram per cubic meter |
Primary
Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C
Static air samples were collected on filters within air pumps positioned in two locations (bench and corner) in the room. Sampling devices attached to sampling pumps were used to measure CCI15106 concentration. Fixed location concentrations were measured in corner of room and on bench at back of room over 20 minutes and 60 minutes post-dosing.
Time frame: Days 1, 7 and 14: 20 and 60 minutes post-dose
Population: Bystander PK Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C | Day 7: 60 minutes- Corner,n=1,1,1,1,1,1,1 | 0.22 Microgram per cubic meter |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C | Day 14: 20 minutes- Corner,n=1,1,1,1,1,1,1 | 0.50 Microgram per cubic meter |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C | Day 7: 20 minutes- Bench,n=1,1,1,1,1,1,1 | 2.39 Microgram per cubic meter |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C | Day 1: 60 minutes- Corner,n=1,1,1,1,1,1,1 | 0.89 Microgram per cubic meter |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C | Day 14: 60 minutes- Bench,n=1,1,1,1,1,1,1 | 0.10 Microgram per cubic meter |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C | Day 7: 20 minutes- Corner,n=1,1,1,1,1,1,1 | 1.52 Microgram per cubic meter |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C | Day 1: 20 minutes- Corner,n=1,1,1,1,1,1,1 | 0.79 Microgram per cubic meter |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C | Day 14: 20 minutes- Bench,n=1,1,1,1,1,1,1 | 0.50 Microgram per cubic meter |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C | Day 7: 60 minutes- Bench,n=1,1,1,1,1,1,1 | 1.22 Microgram per cubic meter |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C | Day 14: 60 minutes- Corner,n=1,1,1,1,1,1,1 | 0.10 Microgram per cubic meter |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C | Day 1: 60 minutes- Bench,n=1,1,1,1,1,1,1 | 0.75 Microgram per cubic meter |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C | Day 1: 20 minutes- Bench,n=1,1,1,1,1,1,1 | 1.46 Microgram per cubic meter |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C | Day 1: 20 minutes- Corner,n=1,1,1,1,1,1,1 | 0.50 Microgram per cubic meter |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C | Day 7: 60 minutes- Corner,n=1,1,1,1,1,1,1 | 1.72 Microgram per cubic meter |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C | Day 1: 60 minutes- Bench,n=1,1,1,1,1,1,1 | 0.15 Microgram per cubic meter |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C | Day 14: 60 minutes- Bench,n=1,1,1,1,1,1,1 | 0.62 Microgram per cubic meter |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C | Day 1: 20 minutes- Bench,n=1,1,1,1,1,1,1 | 0.50 Microgram per cubic meter |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C | Day 14: 20 minutes- Bench,n=1,1,1,1,1,1,1 | 1.39 Microgram per cubic meter |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C | Day 7: 20 minutes- Corner,n=1,1,1,1,1,1,1 | 2.53 Microgram per cubic meter |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C | Day 14: 60 minutes- Corner,n=1,1,1,1,1,1,1 | 0.70 Microgram per cubic meter |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C | Day 7: 20 minutes- Bench,n=1,1,1,1,1,1,1 | 3.32 Microgram per cubic meter |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C | Day 14: 20 minutes- Corner,n=1,1,1,1,1,1,1 | 1.87 Microgram per cubic meter |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C | Day 7: 60 minutes- Bench,n=1,1,1,1,1,1,1 | 1.40 Microgram per cubic meter |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C | Day 1: 60 minutes- Corner,n=1,1,1,1,1,1,1 | 0.13 Microgram per cubic meter |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C | Day 14: 60 minutes- Corner,n=1,1,1,1,1,1,1 | 3.58 Microgram per cubic meter |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C | Day 1: 60 minutes- Bench,n=1,1,1,1,1,1,1 | 0.90 Microgram per cubic meter |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C | Day 7: 20 minutes- Bench,n=1,1,1,1,1,1,1 | 2.34 Microgram per cubic meter |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C | Day 7: 60 minutes- Bench,n=1,1,1,1,1,1,1 | 1.00 Microgram per cubic meter |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C | Day 1: 20 minutes- Bench,n=1,1,1,1,1,1,1 | 1.58 Microgram per cubic meter |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C | Day 14: 20 minutes- Corner,n=1,1,1,1,1,1,1 | 8.54 Microgram per cubic meter |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C | Day 14: 60 minutes- Bench,n=1,1,1,1,1,1,1 | 3.20 Microgram per cubic meter |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C | Day 1: 60 minutes- Corner,n=1,1,1,1,1,1,1 | 0.99 Microgram per cubic meter |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C | Day 1: 20 minutes- Corner,n=1,1,1,1,1,1,1 | 2.09 Microgram per cubic meter |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C | Day 7: 20 minutes- Corner,n=1,1,1,1,1,1,1 | 2.64 Microgram per cubic meter |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C | Day 14: 20 minutes- Bench,n=1,1,1,1,1,1,1 | 6.47 Microgram per cubic meter |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C | Day 7: 60 minutes- Corner,n=1,1,1,1,1,1,1 | 1.19 Microgram per cubic meter |
| Part 1: Cohort A- Placebo | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C | Day 14: 60 minutes- Corner,n=1,1,1,1,1,1,1 | 0.10 Microgram per cubic meter |
| Part 1: Cohort A- Placebo | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C | Day 1: 20 minutes- Bench,n=1,1,1,1,1,1,1 | 3.74 Microgram per cubic meter |
| Part 1: Cohort A- Placebo | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C | Day 7: 60 minutes- Corner,n=1,1,1,1,1,1,1 | 0.19 Microgram per cubic meter |
| Part 1: Cohort A- Placebo | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C | Day 1: 20 minutes- Corner,n=1,1,1,1,1,1,1 | 4.12 Microgram per cubic meter |
| Part 1: Cohort A- Placebo | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C | Day 7: 20 minutes- Bench,n=1,1,1,1,1,1,1 | 0.46 Microgram per cubic meter |
| Part 1: Cohort A- Placebo | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C | Day 14: 60 minutes- Bench,n=1,1,1,1,1,1,1 | 0.14 Microgram per cubic meter |
| Part 1: Cohort A- Placebo | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C | Day 7: 60 minutes- Bench,n=1,1,1,1,1,1,1 | 0.18 Microgram per cubic meter |
| Part 1: Cohort A- Placebo | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C | Day 7: 20 minutes- Corner,n=1,1,1,1,1,1,1 | 0.30 Microgram per cubic meter |
| Part 1: Cohort A- Placebo | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C | Day 14: 20 minutes- Bench,n=1,1,1,1,1,1,1 | 0.27 Microgram per cubic meter |
| Part 1: Cohort A- Placebo | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C | Day 1: 60 minutes- Corner,n=1,1,1,1,1,1,1 | 2.03 Microgram per cubic meter |
| Part 1: Cohort A- Placebo | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C | Day 1: 60 minutes- Bench,n=1,1,1,1,1,1,1 | 2.09 Microgram per cubic meter |
| Part 1: Cohort A- Placebo | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C | Day 14: 20 minutes- Corner,n=1,1,1,1,1,1,1 | 0.36 Microgram per cubic meter |
| Part 1: Placebo | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C | Day 1: 20 minutes- Corner,n=1,1,1,1,1,1,1 | 5.80 Microgram per cubic meter |
| Part 1: Placebo | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C | Day 1: 20 minutes- Bench,n=1,1,1,1,1,1,1 | 4.98 Microgram per cubic meter |
| Part 1: Placebo | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C | Day 7: 20 minutes- Corner,n=1,1,1,1,1,1,1 | 0.30 Microgram per cubic meter |
| Part 1: Placebo | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C | Day 7: 20 minutes- Bench,n=1,1,1,1,1,1,1 | 0.65 Microgram per cubic meter |
| Part 1: Placebo | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C | Day 14: 20 minutes- Corner,n=1,1,1,1,1,1,1 | 0.30 Microgram per cubic meter |
| Part 1: Placebo | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C | Day 14: 20 minutes- Bench,n=1,1,1,1,1,1,1 | 0.50 Microgram per cubic meter |
| Part 1: Placebo | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C | Day 1: 60 minutes- Corner,n=1,1,1,1,1,1,1 | 2.34 Microgram per cubic meter |
| Part 1: Placebo | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C | Day 1: 60 minutes- Bench,n=1,1,1,1,1,1,1 | 2.17 Microgram per cubic meter |
| Part 1: Placebo | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C | Day 7: 60 minutes- Corner,n=1,1,1,1,1,1,1 | 0.34 Microgram per cubic meter |
| Part 1: Placebo | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C | Day 7: 60 minutes- Bench,n=1,1,1,1,1,1,1 | 0.28 Microgram per cubic meter |
| Part 1: Placebo | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C | Day 14: 60 minutes- Corner,n=1,1,1,1,1,1,1 | 0.14 Microgram per cubic meter |
| Part 1: Placebo | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C | Day 14: 60 minutes- Bench,n=1,1,1,1,1,1,1 | 0.11 Microgram per cubic meter |
| Part 1: Bystander Group 4- Session 1 | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C | Day 1: 60 minutes- Corner,n=1,1,1,1,1,1,1 | 0.10 Microgram per cubic meter |
| Part 1: Bystander Group 4- Session 1 | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C | Day 14: 20 minutes- Bench,n=1,1,1,1,1,1,1 | 0.50 Microgram per cubic meter |
| Part 1: Bystander Group 4- Session 1 | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C | Day 7: 60 minutes- Corner,n=1,1,1,1,1,1,1 | 0.10 Microgram per cubic meter |
| Part 1: Bystander Group 4- Session 1 | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C | Day 14: 20 minutes- Corner,n=1,1,1,1,1,1,1 | 0.50 Microgram per cubic meter |
| Part 1: Bystander Group 4- Session 1 | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C | Day 7: 20 minutes- Bench,n=1,1,1,1,1,1,1 | 0.50 Microgram per cubic meter |
| Part 1: Bystander Group 4- Session 1 | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C | Day 7: 60 minutes- Bench,n=1,1,1,1,1,1,1 | 0.10 Microgram per cubic meter |
| Part 1: Bystander Group 4- Session 1 | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C | Day 7: 20 minutes- Corner,n=1,1,1,1,1,1,1 | 0.28 Microgram per cubic meter |
| Part 1: Bystander Group 4- Session 1 | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C | Day 14: 60 minutes- Bench,n=1,1,1,1,1,1,1 | 0.10 Microgram per cubic meter |
| Part 1: Bystander Group 4- Session 1 | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C | Day 14: 60 minutes- Corner,n=1,1,1,1,1,1,1 | 0.10 Microgram per cubic meter |
| Part 1: Bystander Group 4- Session 1 | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C | Day 1: 20 minutes- Bench,n=1,1,1,1,1,1,1 | 0.50 Microgram per cubic meter |
| Part 1: Bystander Group 4- Session 1 | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C | Day 1: 20 minutes- Corner,n=1,1,1,1,1,1,1 | 0.50 Microgram per cubic meter |
| Part 1: Bystander Group 4- Session 1 | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C | Day 1: 60 minutes- Bench,n=1,1,1,1,1,1,1 | 0.10 Microgram per cubic meter |
| Part 1: Bystander Group 4- Session 2 | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C | Day 1: 20 minutes- Corner,n=1,1,1,1,1,1,1 | 0.50 Microgram per cubic meter |
| Part 1: Bystander Group 4- Session 2 | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C | Day 1: 20 minutes- Bench,n=1,1,1,1,1,1,1 | 0.50 Microgram per cubic meter |
| Part 1: Bystander Group 4- Session 2 | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C | Day 1: 60 minutes- Corner,n=1,1,1,1,1,1,1 | 0.10 Microgram per cubic meter |
| Part 1: Bystander Group 4- Session 2 | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C | Day 7: 60 minutes- Corner,n=1,1,1,1,1,1,1 | 0.46 Microgram per cubic meter |
| Part 1: Bystander Group 4- Session 2 | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C | Day 14: 20 minutes- Corner,n=1,1,1,1,1,1,1 | 0.50 Microgram per cubic meter |
| Part 1: Bystander Group 4- Session 2 | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C | Day 14: 20 minutes- Bench,n=1,1,1,1,1,1,1 | 0.50 Microgram per cubic meter |
| Part 1: Bystander Group 4- Session 2 | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C | Day 7: 20 minutes- Bench,n=1,1,1,1,1,1,1 | 1.13 Microgram per cubic meter |
| Part 1: Bystander Group 4- Session 2 | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C | Day 14: 60 minutes- Corner,n=1,1,1,1,1,1,1 | 0.10 Microgram per cubic meter |
| Part 1: Bystander Group 4- Session 2 | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C | Day 14: 60 minutes- Bench,n=1,1,1,1,1,1,1 | 0.10 Microgram per cubic meter |
| Part 1: Bystander Group 4- Session 2 | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C | Day 1: 60 minutes- Bench,n=1,1,1,1,1,1,1 | 0.10 Microgram per cubic meter |
| Part 1: Bystander Group 4- Session 2 | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C | Day 7: 60 minutes- Bench,n=1,1,1,1,1,1,1 | 0.52 Microgram per cubic meter |
| Part 1: Bystander Group 4- Session 2 | Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C | Day 7: 20 minutes- Corner,n=1,1,1,1,1,1,1 | 1.01 Microgram per cubic meter |
Primary
Part 1: Concentration of CCI15106 in Plasma of Bystanders: Cohort C
Blood samples were collected from bystanders 15 minutes after dosing at indicated time points. Bystander PK population consisted of participants who were present at least once in the room with the participant receiving the dose, undergo plasma PK sampling and had post-dose concentration result.
Time frame: Days 1, 7 and 14: pre-dose, 15 minutes post-dose
Population: Bystander PK Population. NA indicates that, data could not be analyzed because data was below level of quantification.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Concentration of CCI15106 in Plasma of Bystanders: Cohort C | NA Nanogram per milliliter |
Primary
Part 1: Number of Participants With Abnormal Telemetry Findings
Continuous cardiac telemetry was performed from approximately 0.5 hour (pre-dose) to 4 hours post-dose. Abnormal findings were categorized as clinically significant (CS) and not clinically significant (NCS). 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.
Time frame: Days 1, 3, 6, 7, 12 and 18: 0.5 hour (pre-dose) to 4 hours post-dose
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). The primary aim was to compare the safety profiles of the different active doses; hence, placebo arms have been combined as pre-specified in reporting and analysis plan.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Number of Participants With Abnormal Telemetry Findings | Day 1: 0.5 to 4 hours post-dose-CS;n=6,0,0,12,4 | 0 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Number of Participants With Abnormal Telemetry Findings | Day 1: 0.5 to 4 hours post-dose-NCS;n=6,0,0,12,4 | 0 Participants |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 1: Number of Participants With Abnormal Telemetry Findings | Day 3: 0.5 to 4 hours post-dose-NCS;n=0,6,0,0,2 | 0 Participants |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 1: Number of Participants With Abnormal Telemetry Findings | Day 3: 0.5 to 4 hours post-dose-CS;n=0,6,0,0,2 | 0 Participants |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 1: Number of Participants With Abnormal Telemetry Findings | Day 12: 0.5 to 4 hours post-dose-NCS;n=0,0,6,12,4 | 0 Participants |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 1: Number of Participants With Abnormal Telemetry Findings | Day 6: 0.5 to 4 hours post-dose-CS;n=0,0,6,0,2 | 0 Participants |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 1: Number of Participants With Abnormal Telemetry Findings | Day 12: 0.5 to 4 hours post-dose-CS;n=0,0,6,12,4 | 0 Participants |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 1: Number of Participants With Abnormal Telemetry Findings | Day 6: 0.5 to 4 hours post-dose-NCS;n=0,0,6,0,2 | 0 Participants |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 1: Number of Participants With Abnormal Telemetry Findings | Day 18: 0.5 to 4 hours post-dose-NCS;n=0,0,6,0,2 | 0 Participants |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 1: Number of Participants With Abnormal Telemetry Findings | Day 18: 0.5 to 4 hours post-dose-CS;n=0,0,6,0,2 | 0 Participants |
| Part 1: Cohort A- Placebo | Part 1: Number of Participants With Abnormal Telemetry Findings | Day 7: 0.5 to 4 hours post-dose-CS;n=0,0,0,12,2 | 0 Participants |
| Part 1: Cohort A- Placebo | Part 1: Number of Participants With Abnormal Telemetry Findings | Day 1: 0.5 to 4 hours post-dose-CS;n=6,0,0,12,4 | 0 Participants |
| Part 1: Cohort A- Placebo | Part 1: Number of Participants With Abnormal Telemetry Findings | Day 1: 0.5 to 4 hours post-dose-NCS;n=6,0,0,12,4 | 0 Participants |
| Part 1: Cohort A- Placebo | Part 1: Number of Participants With Abnormal Telemetry Findings | Day 7: 0.5 to 4 hours post-dose-NCS;n=0,0,0,12,2 | 0 Participants |
| Part 1: Cohort A- Placebo | Part 1: Number of Participants With Abnormal Telemetry Findings | Day 12: 0.5 to 4 hours post-dose-CS;n=0,0,6,12,4 | 0 Participants |
| Part 1: Cohort A- Placebo | Part 1: Number of Participants With Abnormal Telemetry Findings | Day 12: 0.5 to 4 hours post-dose-NCS;n=0,0,6,12,4 | 0 Participants |
| Part 1: Placebo | Part 1: Number of Participants With Abnormal Telemetry Findings | Day 18: 0.5 to 4 hours post-dose-CS;n=0,0,6,0,2 | 0 Participants |
| Part 1: Placebo | Part 1: Number of Participants With Abnormal Telemetry Findings | Day 7: 0.5 to 4 hours post-dose-NCS;n=0,0,0,12,2 | 0 Participants |
| Part 1: Placebo | Part 1: Number of Participants With Abnormal Telemetry Findings | Day 3: 0.5 to 4 hours post-dose-CS;n=0,6,0,0,2 | 0 Participants |
| Part 1: Placebo | Part 1: Number of Participants With Abnormal Telemetry Findings | Day 3: 0.5 to 4 hours post-dose-NCS;n=0,6,0,0,2 | 0 Participants |
| Part 1: Placebo | Part 1: Number of Participants With Abnormal Telemetry Findings | Day 12: 0.5 to 4 hours post-dose-CS;n=0,0,6,12,4 | 0 Participants |
| Part 1: Placebo | Part 1: Number of Participants With Abnormal Telemetry Findings | Day 1: 0.5 to 4 hours post-dose-NCS;n=6,0,0,12,4 | 0 Participants |
| Part 1: Placebo | Part 1: Number of Participants With Abnormal Telemetry Findings | Day 18: 0.5 to 4 hours post-dose-NCS;n=0,0,6,0,2 | 0 Participants |
| Part 1: Placebo | Part 1: Number of Participants With Abnormal Telemetry Findings | Day 12: 0.5 to 4 hours post-dose-NCS;n=0,0,6,12,4 | 1 Participants |
| Part 1: Placebo | Part 1: Number of Participants With Abnormal Telemetry Findings | Day 1: 0.5 to 4 hours post-dose-CS;n=6,0,0,12,4 | 0 Participants |
| Part 1: Placebo | Part 1: Number of Participants With Abnormal Telemetry Findings | Day 6: 0.5 to 4 hours post-dose-NCS;n=0,0,6,0,2 | 0 Participants |
| Part 1: Placebo | Part 1: Number of Participants With Abnormal Telemetry Findings | Day 6: 0.5 to 4 hours post-dose-CS;n=0,0,6,0,2 | 0 Participants |
| Part 1: Placebo | Part 1: Number of Participants With Abnormal Telemetry Findings | Day 7: 0.5 to 4 hours post-dose-CS;n=0,0,0,12,2 | 0 Participants |
Primary
Part 1: Number of Participants With Clinical Chemistry Values of PCI in Bystanders
PCI ranges for the clinical chemistry parameters were as follows: albumin (low: \<30 mmol/L), calcium (low: \<2 mmol/L and high: \>2.75 mmol/L), glucose (low: \<3 mmol/L and high: \>9 mmol/L), potassium (low: \<3 mmol/L and high: \>5.5 mmol/L) and sodium (low: \<130 mmol/L and high: \>150 mmol/L). Data for the participants with high and low values has been reported.
Time frame: Up to 46 days
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Number of Participants With Clinical Chemistry Values of PCI in Bystanders | Albumin: low | 0 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Number of Participants With Clinical Chemistry Values of PCI in Bystanders | Calcium: low | 0 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Number of Participants With Clinical Chemistry Values of PCI in Bystanders | Calcium: high | 0 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Number of Participants With Clinical Chemistry Values of PCI in Bystanders | Glucose: low | 0 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Number of Participants With Clinical Chemistry Values of PCI in Bystanders | Glucose: high | 0 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Number of Participants With Clinical Chemistry Values of PCI in Bystanders | Potassium: low | 0 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Number of Participants With Clinical Chemistry Values of PCI in Bystanders | Potassium: high | 0 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Number of Participants With Clinical Chemistry Values of PCI in Bystanders | Sodium: low | 0 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Number of Participants With Clinical Chemistry Values of PCI in Bystanders | Sodium: high | 0 Participants |
Primary
Part 1: Number of Participants With Clinical Chemistry Values of PCI in CCI15106
PCI ranges for the clinical chemistry parameters were as follows: albumin (low: \<30 millimole per liter \[mmol/L\]), calcium (low: \<2 mmol/L and high: \>2.75 mmol/L), glucose (low: \<3 mmol/L and high: \>9 mmol/L), potassium (low: \<3 mmol/L and high: \>5.5 mmol/L) and sodium (low: \<130 mmol/L and high: \>150 mmol/L). Data for the participants with high and low values has been reported.
Time frame: Up to 51 days
Population: Safety Population. The primary aim was to compare the safety profiles of the different active doses; hence, placebo arms have been combined as pre-specified in reporting and analysis plan.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Number of Participants With Clinical Chemistry Values of PCI in CCI15106 | Potassium: low | 0 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Number of Participants With Clinical Chemistry Values of PCI in CCI15106 | Potassium: high | 0 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Number of Participants With Clinical Chemistry Values of PCI in CCI15106 | Calcium: low | 0 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Number of Participants With Clinical Chemistry Values of PCI in CCI15106 | Albumin: low | 0 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Number of Participants With Clinical Chemistry Values of PCI in CCI15106 | Sodium: high | 0 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Number of Participants With Clinical Chemistry Values of PCI in CCI15106 | Calcium: high | 0 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Number of Participants With Clinical Chemistry Values of PCI in CCI15106 | Glucose: low | 0 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Number of Participants With Clinical Chemistry Values of PCI in CCI15106 | Glucose: high | 0 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Number of Participants With Clinical Chemistry Values of PCI in CCI15106 | Sodium: low | 0 Participants |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 1: Number of Participants With Clinical Chemistry Values of PCI in CCI15106 | Calcium: low | 0 Participants |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 1: Number of Participants With Clinical Chemistry Values of PCI in CCI15106 | Sodium: low | 0 Participants |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 1: Number of Participants With Clinical Chemistry Values of PCI in CCI15106 | Glucose: high | 0 Participants |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 1: Number of Participants With Clinical Chemistry Values of PCI in CCI15106 | Calcium: high | 0 Participants |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 1: Number of Participants With Clinical Chemistry Values of PCI in CCI15106 | Albumin: low | 0 Participants |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 1: Number of Participants With Clinical Chemistry Values of PCI in CCI15106 | Glucose: low | 0 Participants |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 1: Number of Participants With Clinical Chemistry Values of PCI in CCI15106 | Potassium: low | 0 Participants |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 1: Number of Participants With Clinical Chemistry Values of PCI in CCI15106 | Sodium: high | 0 Participants |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 1: Number of Participants With Clinical Chemistry Values of PCI in CCI15106 | Potassium: high | 0 Participants |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 1: Number of Participants With Clinical Chemistry Values of PCI in CCI15106 | Calcium: low | 0 Participants |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 1: Number of Participants With Clinical Chemistry Values of PCI in CCI15106 | Potassium: high | 0 Participants |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 1: Number of Participants With Clinical Chemistry Values of PCI in CCI15106 | Sodium: high | 0 Participants |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 1: Number of Participants With Clinical Chemistry Values of PCI in CCI15106 | Potassium: low | 0 Participants |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 1: Number of Participants With Clinical Chemistry Values of PCI in CCI15106 | Albumin: low | 0 Participants |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 1: Number of Participants With Clinical Chemistry Values of PCI in CCI15106 | Calcium: high | 0 Participants |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 1: Number of Participants With Clinical Chemistry Values of PCI in CCI15106 | Glucose: low | 0 Participants |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 1: Number of Participants With Clinical Chemistry Values of PCI in CCI15106 | Sodium: low | 0 Participants |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 1: Number of Participants With Clinical Chemistry Values of PCI in CCI15106 | Glucose: high | 0 Participants |
| Part 1: Cohort A- Placebo | Part 1: Number of Participants With Clinical Chemistry Values of PCI in CCI15106 | Sodium: high | 0 Participants |
| Part 1: Cohort A- Placebo | Part 1: Number of Participants With Clinical Chemistry Values of PCI in CCI15106 | Albumin: low | 0 Participants |
| Part 1: Cohort A- Placebo | Part 1: Number of Participants With Clinical Chemistry Values of PCI in CCI15106 | Calcium: low | 0 Participants |
| Part 1: Cohort A- Placebo | Part 1: Number of Participants With Clinical Chemistry Values of PCI in CCI15106 | Calcium: high | 0 Participants |
| Part 1: Cohort A- Placebo | Part 1: Number of Participants With Clinical Chemistry Values of PCI in CCI15106 | Glucose: low | 0 Participants |
| Part 1: Cohort A- Placebo | Part 1: Number of Participants With Clinical Chemistry Values of PCI in CCI15106 | Glucose: high | 0 Participants |
| Part 1: Cohort A- Placebo | Part 1: Number of Participants With Clinical Chemistry Values of PCI in CCI15106 | Potassium: low | 0 Participants |
| Part 1: Cohort A- Placebo | Part 1: Number of Participants With Clinical Chemistry Values of PCI in CCI15106 | Potassium: high | 0 Participants |
| Part 1: Cohort A- Placebo | Part 1: Number of Participants With Clinical Chemistry Values of PCI in CCI15106 | Sodium: low | 0 Participants |
| Part 1: Placebo | Part 1: Number of Participants With Clinical Chemistry Values of PCI in CCI15106 | Glucose: high | 0 Participants |
| Part 1: Placebo | Part 1: Number of Participants With Clinical Chemistry Values of PCI in CCI15106 | Glucose: low | 0 Participants |
| Part 1: Placebo | Part 1: Number of Participants With Clinical Chemistry Values of PCI in CCI15106 | Calcium: high | 0 Participants |
| Part 1: Placebo | Part 1: Number of Participants With Clinical Chemistry Values of PCI in CCI15106 | Potassium: low | 0 Participants |
| Part 1: Placebo | Part 1: Number of Participants With Clinical Chemistry Values of PCI in CCI15106 | Sodium: low | 0 Participants |
| Part 1: Placebo | Part 1: Number of Participants With Clinical Chemistry Values of PCI in CCI15106 | Calcium: low | 0 Participants |
| Part 1: Placebo | Part 1: Number of Participants With Clinical Chemistry Values of PCI in CCI15106 | Albumin: low | 0 Participants |
| Part 1: Placebo | Part 1: Number of Participants With Clinical Chemistry Values of PCI in CCI15106 | Sodium: high | 0 Participants |
| Part 1: Placebo | Part 1: Number of Participants With Clinical Chemistry Values of PCI in CCI15106 | Potassium: high | 0 Participants |
Primary
Part 1: Number of Participants With Hematology Values of PCI in Bystanders
PCI ranges for the hematology parameters were as follows: hematocrit (high: \>0.54 proportion of RBC in blood for male, \>0.54 proportion of RBC in blood for female), hemoglobin (high: \>180 g/L in male, \>180 g/L in female), lymphocytes (low: \<0.8 10\^9/L), neutrophil count (low: \<1.5 10\^9/L) and platelet count (low: \<100 10\^9/L and high: 550 10\^9/L). Data for the participants with high and low values has been reported.
Time frame: Up to 46 days
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Number of Participants With Hematology Values of PCI in Bystanders | Hematocrit: high | 0 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Number of Participants With Hematology Values of PCI in Bystanders | Hemoglobin: high | 0 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Number of Participants With Hematology Values of PCI in Bystanders | Lymphocytes: low | 0 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Number of Participants With Hematology Values of PCI in Bystanders | Neutrophil count: low | 0 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Number of Participants With Hematology Values of PCI in Bystanders | Platelet count: low | 0 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Number of Participants With Hematology Values of PCI in Bystanders | Platelet count: high | 0 Participants |
Primary
Part 1: Number of Participants With Hematology Values of Potential Clinical Importance (PCI) in CCI15106
PCI ranges for the hematology parameters were as follows: hematocrit (high: \>0.54 proportion of red blood cell \[RBC\] in blood for male, \>0.54 proportion of RBC in blood for female), hemoglobin (high: \>180 grams \[g\]/L in male, \>180 g/L in female), lymphocytes (low: \<0.8 10\^9/L), neutrophil count (low: \<1.5 10\^9/L) and platelet count (low: \<100 10\^9/L and high: 550 10\^9/L). Data for the participants with high and low values has been reported.
Time frame: Up to 51 days
Population: Safety Population. The primary aim was to compare the safety profiles of the different active doses; hence, placebo arms have been combined as pre-specified in reporting and analysis plan.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Number of Participants With Hematology Values of Potential Clinical Importance (PCI) in CCI15106 | Lymphocytes: low | 0 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Number of Participants With Hematology Values of Potential Clinical Importance (PCI) in CCI15106 | Hematocrit: high | 0 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Number of Participants With Hematology Values of Potential Clinical Importance (PCI) in CCI15106 | Hemoglobin: high | 0 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Number of Participants With Hematology Values of Potential Clinical Importance (PCI) in CCI15106 | Neutrophil count: low | 0 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Number of Participants With Hematology Values of Potential Clinical Importance (PCI) in CCI15106 | Platelet count: low | 0 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Number of Participants With Hematology Values of Potential Clinical Importance (PCI) in CCI15106 | Platelet count: high | 0 Participants |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 1: Number of Participants With Hematology Values of Potential Clinical Importance (PCI) in CCI15106 | Platelet count: low | 0 Participants |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 1: Number of Participants With Hematology Values of Potential Clinical Importance (PCI) in CCI15106 | Hemoglobin: high | 0 Participants |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 1: Number of Participants With Hematology Values of Potential Clinical Importance (PCI) in CCI15106 | Hematocrit: high | 0 Participants |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 1: Number of Participants With Hematology Values of Potential Clinical Importance (PCI) in CCI15106 | Lymphocytes: low | 0 Participants |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 1: Number of Participants With Hematology Values of Potential Clinical Importance (PCI) in CCI15106 | Neutrophil count: low | 1 Participants |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 1: Number of Participants With Hematology Values of Potential Clinical Importance (PCI) in CCI15106 | Platelet count: high | 0 Participants |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 1: Number of Participants With Hematology Values of Potential Clinical Importance (PCI) in CCI15106 | Neutrophil count: low | 0 Participants |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 1: Number of Participants With Hematology Values of Potential Clinical Importance (PCI) in CCI15106 | Platelet count: low | 0 Participants |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 1: Number of Participants With Hematology Values of Potential Clinical Importance (PCI) in CCI15106 | Hematocrit: high | 0 Participants |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 1: Number of Participants With Hematology Values of Potential Clinical Importance (PCI) in CCI15106 | Lymphocytes: low | 0 Participants |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 1: Number of Participants With Hematology Values of Potential Clinical Importance (PCI) in CCI15106 | Hemoglobin: high | 0 Participants |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 1: Number of Participants With Hematology Values of Potential Clinical Importance (PCI) in CCI15106 | Platelet count: high | 0 Participants |
| Part 1: Cohort A- Placebo | Part 1: Number of Participants With Hematology Values of Potential Clinical Importance (PCI) in CCI15106 | Neutrophil count: low | 0 Participants |
| Part 1: Cohort A- Placebo | Part 1: Number of Participants With Hematology Values of Potential Clinical Importance (PCI) in CCI15106 | Hemoglobin: high | 0 Participants |
| Part 1: Cohort A- Placebo | Part 1: Number of Participants With Hematology Values of Potential Clinical Importance (PCI) in CCI15106 | Lymphocytes: low | 0 Participants |
| Part 1: Cohort A- Placebo | Part 1: Number of Participants With Hematology Values of Potential Clinical Importance (PCI) in CCI15106 | Platelet count: high | 0 Participants |
| Part 1: Cohort A- Placebo | Part 1: Number of Participants With Hematology Values of Potential Clinical Importance (PCI) in CCI15106 | Platelet count: low | 0 Participants |
| Part 1: Cohort A- Placebo | Part 1: Number of Participants With Hematology Values of Potential Clinical Importance (PCI) in CCI15106 | Hematocrit: high | 0 Participants |
| Part 1: Placebo | Part 1: Number of Participants With Hematology Values of Potential Clinical Importance (PCI) in CCI15106 | Platelet count: low | 0 Participants |
| Part 1: Placebo | Part 1: Number of Participants With Hematology Values of Potential Clinical Importance (PCI) in CCI15106 | Platelet count: high | 0 Participants |
| Part 1: Placebo | Part 1: Number of Participants With Hematology Values of Potential Clinical Importance (PCI) in CCI15106 | Lymphocytes: low | 0 Participants |
| Part 1: Placebo | Part 1: Number of Participants With Hematology Values of Potential Clinical Importance (PCI) in CCI15106 | Hemoglobin: high | 0 Participants |
| Part 1: Placebo | Part 1: Number of Participants With Hematology Values of Potential Clinical Importance (PCI) in CCI15106 | Neutrophil count: low | 0 Participants |
| Part 1: Placebo | Part 1: Number of Participants With Hematology Values of Potential Clinical Importance (PCI) in CCI15106 | Hematocrit: high | 0 Participants |
Primary
Part 1: Number of Participants With Vital Signs Values of PCI
PCI ranges for the vital signs parameters were as follows: systolic blood pressure (SBP) \<85 and \>160 millimeters of mercury (mmHg), diastolic blood pressure (DBP) \<45 and \>100 mmHg and heart rate \<40 and \>110 beats per minute (bpm). Data for the participants with high and low values has been reported.
Time frame: Up to 51 days
Population: Safety Population. The primary aim was to compare the safety profiles of the different active doses; hence, placebo arms have been combined as pre-specified in reporting and analysis plan.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Number of Participants With Vital Signs Values of PCI | SBP: low | 0 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Number of Participants With Vital Signs Values of PCI | DBP: low | 0 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Number of Participants With Vital Signs Values of PCI | SBP: high | 0 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Number of Participants With Vital Signs Values of PCI | Heart rate: high | 0 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Number of Participants With Vital Signs Values of PCI | DBP: high | 0 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Number of Participants With Vital Signs Values of PCI | Heart rate: low | 0 Participants |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 1: Number of Participants With Vital Signs Values of PCI | SBP: low | 0 Participants |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 1: Number of Participants With Vital Signs Values of PCI | Heart rate: high | 0 Participants |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 1: Number of Participants With Vital Signs Values of PCI | DBP: high | 0 Participants |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 1: Number of Participants With Vital Signs Values of PCI | Heart rate: low | 0 Participants |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 1: Number of Participants With Vital Signs Values of PCI | SBP: high | 0 Participants |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 1: Number of Participants With Vital Signs Values of PCI | DBP: low | 0 Participants |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 1: Number of Participants With Vital Signs Values of PCI | Heart rate: low | 0 Participants |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 1: Number of Participants With Vital Signs Values of PCI | Heart rate: high | 0 Participants |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 1: Number of Participants With Vital Signs Values of PCI | DBP: low | 0 Participants |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 1: Number of Participants With Vital Signs Values of PCI | SBP: low | 0 Participants |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 1: Number of Participants With Vital Signs Values of PCI | DBP: high | 0 Participants |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 1: Number of Participants With Vital Signs Values of PCI | SBP: high | 0 Participants |
| Part 1: Cohort A- Placebo | Part 1: Number of Participants With Vital Signs Values of PCI | SBP: high | 0 Participants |
| Part 1: Cohort A- Placebo | Part 1: Number of Participants With Vital Signs Values of PCI | SBP: low | 0 Participants |
| Part 1: Cohort A- Placebo | Part 1: Number of Participants With Vital Signs Values of PCI | DBP: high | 0 Participants |
| Part 1: Cohort A- Placebo | Part 1: Number of Participants With Vital Signs Values of PCI | DBP: low | 0 Participants |
| Part 1: Cohort A- Placebo | Part 1: Number of Participants With Vital Signs Values of PCI | Heart rate: high | 0 Participants |
| Part 1: Cohort A- Placebo | Part 1: Number of Participants With Vital Signs Values of PCI | Heart rate: low | 0 Participants |
| Part 1: Placebo | Part 1: Number of Participants With Vital Signs Values of PCI | Heart rate: high | 0 Participants |
| Part 1: Placebo | Part 1: Number of Participants With Vital Signs Values of PCI | DBP: low | 0 Participants |
| Part 1: Placebo | Part 1: Number of Participants With Vital Signs Values of PCI | DBP: high | 0 Participants |
| Part 1: Placebo | Part 1: Number of Participants With Vital Signs Values of PCI | SBP: low | 0 Participants |
| Part 1: Placebo | Part 1: Number of Participants With Vital Signs Values of PCI | SBP: high | 0 Participants |
| Part 1: Placebo | Part 1: Number of Participants With Vital Signs Values of PCI | Heart rate: low | 0 Participants |
Primary
Part 1: Number of Participants With Vital Signs Values of PCI in Bystanders
PCI ranges for the vital signs parameters were as follows: SBP \<85 and \>160 mmHg, DBP \<45 and \>100 mmHg and heart rate \<40 and \>110 bpm. Data for the participants with high and low values has been reported.
Time frame: Up to 46 days
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Number of Participants With Vital Signs Values of PCI in Bystanders | Heart rate: high | 0 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Number of Participants With Vital Signs Values of PCI in Bystanders | DBP: low | 1 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Number of Participants With Vital Signs Values of PCI in Bystanders | DBP: high | 0 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Number of Participants With Vital Signs Values of PCI in Bystanders | SBP: low | 1 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Number of Participants With Vital Signs Values of PCI in Bystanders | SBP: high | 0 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Number of Participants With Vital Signs Values of PCI in Bystanders | Heart rate: low | 0 Participants |
Primary
Part 1: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI in Bystander
PCI ranges for the ECG parameters were as follows: absolute QTc interval \>450 and \<480, \>=480 and \<500, \>=500 msec, absolute PR interval \<110 and \>220 msec and absolute QRS interval \<75 and \>110 msec. Data for worst case post-Baseline has been reported.
Time frame: Up to 46 days
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI in Bystander | PR interval: 110<=Value<=220 | 14 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI in Bystander | PR interval: Value>220 | 0 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI in Bystander | PR interval: Value<110 | 0 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI in Bystander | QRS duration: Value<75 | 0 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI in Bystander | QRS duration: 75<=Value<=110 | 13 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI in Bystander | QRS duration: Value>110 | 1 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI in Bystander | QT interval: Value<=450 | 13 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI in Bystander | QT interval: 450<Value<480 | 1 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI in Bystander | QT interval: 480<=Value<500 | 0 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI in Bystander | QT interval: Value>=500 | 0 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI in Bystander | QTcB interval: Value<=450 | 14 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI in Bystander | QTcB interval: 450<Value<480 | 0 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI in Bystander | QTcB interval: 480<=Value<500 | 0 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI in Bystander | QTcB interval: Value>=500 | 0 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI in Bystander | QTcF interval: Value<=450 | 14 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI in Bystander | QTcF interval: 450<Value<480 | 0 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI in Bystander | QTcF interval: 480<=Value<500 | 0 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI in Bystander | QTcF interval: Value>=500 | 0 Participants |
Primary
Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106
PCI ranges for the ECG parameters were as follows: absolute QTc interval \>450 and \<480, \>=480 and \<500, \>=500 milliseconds (msec), absolute PR interval \<110 and \>220 msec and absolute QRS interval \<75 and \>110 msec. QTcF=Frederica's QT interval corrected for heart rate; QTcB=Bazett's QT interval corrected for heart rate. Data for worst case post-Baseline has been reported.
Time frame: Up to 51 days
Population: Safety Population. The primary aim was to compare the safety profiles of the different active doses; hence, placebo arms have been combined as pre-specified in reporting and analysis plan.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106 | QRS duration: Value<75 | 0 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106 | QTcF interval: Value<=450 | 6 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106 | PR interval: 110<=Value<=220 | 6 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106 | QTcB interval: 450<Value<480 | 0 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106 | QT interval: 450<Value<480 | 1 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106 | QRS duration: 75<=Value<=110 | 4 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106 | QTcB interval: 480<=Value<500 | 0 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106 | QT interval: Value<=450 | 5 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106 | QTcF interval: 480<=Value<500 | 0 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106 | QTcB interval: Value<=450 | 6 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106 | QRS duration: Value>110 | 2 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106 | QTcF interval: 450<Value<480 | 0 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106 | PR interval: Value>220 | 0 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106 | QTcB interval: Value>=500 | 0 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106 | QT interval: Value>=500 | 0 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106 | QT interval: 480<=Value<500 | 0 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106 | PR interval: Value<110 | 0 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106 | QTcF interval: Value>=500 | 0 Participants |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106 | QTcF interval: 480<=Value<500 | 0 Participants |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106 | QTcF interval: Value<=450 | 6 Participants |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106 | QTcB interval: 450<Value<480 | 0 Participants |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106 | QTcF interval: Value>=500 | 0 Participants |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106 | QTcB interval: Value>=500 | 0 Participants |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106 | QTcB interval: 480<=Value<500 | 0 Participants |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106 | PR interval: Value>220 | 0 Participants |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106 | QRS duration: Value<75 | 0 Participants |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106 | PR interval: Value<110 | 0 Participants |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106 | QRS duration: 75<=Value<=110 | 6 Participants |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106 | QTcB interval: Value<=450 | 6 Participants |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106 | QRS duration: Value>110 | 0 Participants |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106 | QT interval: Value<=450 | 6 Participants |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106 | QT interval: 450<Value<480 | 0 Participants |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106 | QTcF interval: 450<Value<480 | 0 Participants |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106 | QT interval: 480<=Value<500 | 0 Participants |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106 | PR interval: 110<=Value<=220 | 6 Participants |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106 | QT interval: Value>=500 | 0 Participants |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106 | QTcF interval: Value>=500 | 0 Participants |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106 | QTcF interval: 450<Value<480 | 0 Participants |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106 | QTcF interval: 480<=Value<500 | 0 Participants |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106 | QTcB interval: Value<=450 | 6 Participants |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106 | QT interval: 450<Value<480 | 0 Participants |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106 | QRS duration: Value<75 | 0 Participants |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106 | QT interval: Value>=500 | 0 Participants |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106 | PR interval: Value>220 | 0 Participants |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106 | PR interval: 110<=Value<=220 | 6 Participants |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106 | QT interval: 480<=Value<500 | 0 Participants |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106 | QTcB interval: Value>=500 | 0 Participants |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106 | QTcB interval: 480<=Value<500 | 0 Participants |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106 | QRS duration: Value>110 | 1 Participants |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106 | QTcF interval: Value<=450 | 6 Participants |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106 | PR interval: Value<110 | 0 Participants |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106 | QRS duration: 75<=Value<=110 | 5 Participants |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106 | QTcB interval: 450<Value<480 | 0 Participants |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106 | QT interval: Value<=450 | 6 Participants |
| Part 1: Cohort A- Placebo | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106 | PR interval: 110<=Value<=220 | 12 Participants |
| Part 1: Cohort A- Placebo | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106 | QTcF interval: 450<Value<480 | 1 Participants |
| Part 1: Cohort A- Placebo | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106 | PR interval: Value<110 | 0 Participants |
| Part 1: Cohort A- Placebo | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106 | PR interval: Value>220 | 0 Participants |
| Part 1: Cohort A- Placebo | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106 | QRS duration: Value<75 | 0 Participants |
| Part 1: Cohort A- Placebo | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106 | QRS duration: 75<=Value<=110 | 9 Participants |
| Part 1: Cohort A- Placebo | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106 | QRS duration: Value>110 | 3 Participants |
| Part 1: Cohort A- Placebo | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106 | QT interval: Value<=450 | 11 Participants |
| Part 1: Cohort A- Placebo | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106 | QT interval: 450<Value<480 | 1 Participants |
| Part 1: Cohort A- Placebo | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106 | QT interval: 480<=Value<500 | 0 Participants |
| Part 1: Cohort A- Placebo | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106 | QT interval: Value>=500 | 0 Participants |
| Part 1: Cohort A- Placebo | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106 | QTcB interval: Value<=450 | 8 Participants |
| Part 1: Cohort A- Placebo | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106 | QTcB interval: 450<Value<480 | 4 Participants |
| Part 1: Cohort A- Placebo | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106 | QTcB interval: 480<=Value<500 | 0 Participants |
| Part 1: Cohort A- Placebo | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106 | QTcB interval: Value>=500 | 0 Participants |
| Part 1: Cohort A- Placebo | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106 | QTcF interval: Value<=450 | 11 Participants |
| Part 1: Cohort A- Placebo | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106 | QTcF interval: 480<=Value<500 | 0 Participants |
| Part 1: Cohort A- Placebo | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106 | QTcF interval: Value>=500 | 0 Participants |
| Part 1: Placebo | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106 | QTcB interval: Value>=500 | 0 Participants |
| Part 1: Placebo | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106 | QT interval: Value>=500 | 0 Participants |
| Part 1: Placebo | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106 | PR interval: Value<110 | 0 Participants |
| Part 1: Placebo | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106 | QTcF interval: Value<=450 | 4 Participants |
| Part 1: Placebo | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106 | QT interval: 480<=Value<500 | 0 Participants |
| Part 1: Placebo | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106 | QT interval: 450<Value<480 | 0 Participants |
| Part 1: Placebo | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106 | QT interval: Value<=450 | 4 Participants |
| Part 1: Placebo | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106 | QTcF interval: 450<Value<480 | 0 Participants |
| Part 1: Placebo | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106 | QRS duration: Value>110 | 1 Participants |
| Part 1: Placebo | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106 | QRS duration: 75<=Value<=110 | 3 Participants |
| Part 1: Placebo | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106 | QRS duration: Value<75 | 0 Participants |
| Part 1: Placebo | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106 | QTcF interval: Value>=500 | 0 Participants |
| Part 1: Placebo | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106 | QTcF interval: 480<=Value<500 | 0 Participants |
| Part 1: Placebo | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106 | PR interval: Value>220 | 0 Participants |
| Part 1: Placebo | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106 | QTcB interval: 480<=Value<500 | 0 Participants |
| Part 1: Placebo | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106 | QTcB interval: 450<Value<480 | 0 Participants |
| Part 1: Placebo | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106 | QTcB interval: Value<=450 | 4 Participants |
| Part 1: Placebo | Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106 | PR interval: 110<=Value<=220 | 4 Participants |
Primary
Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points
FEV1 is a measure of lung function and the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured using standard spirometry. Percent predicted FEV1 was calculated as: Percent predicted FEV1=(maximum FEV1 divided by predicted normal FEV1)\*100.
Time frame: Days 1, 3, 6 and 19: pre-dose, 0.25, 0.5, 1 and 4 hours post-dose; Days 8, 11 and 16: pre-dose and 4 hours post-dose; Day 14: pre-dose, 0.5, 1 and 4 hours post-dose
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). The primary aim was to compare the safety profiles of the different active doses; hence, placebo arms have been combined as pre-specified in reporting and analysis plan.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points | Day 1: pre-dose, n=6,0,0,12,4 | 101.0 Percent predicted FEV1 | Standard Deviation 8.49 |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points | Day 1: 0.5 hour, n=6,0,0,12,4 | 104.3 Percent predicted FEV1 | Standard Deviation 7.17 |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points | Day 1: 0.25 hour, n=6,0,0,0,2 | 101.5 Percent predicted FEV1 | Standard Deviation 7.87 |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points | Day 1: 4 hours, n=6,0,0,12,4 | 104.5 Percent predicted FEV1 | Standard Deviation 8.04 |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points | Day 1: 1 hour, n=6,0,0,12,4 | 105.2 Percent predicted FEV1 | Standard Deviation 6.62 |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points | Day 3: 1 hour, n=0,6,0,0,2 | 104.3 Percent predicted FEV1 | Standard Deviation 6.68 |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points | Day 3: 0.25 hour, n=0,6,0,0,2 | 103.2 Percent predicted FEV1 | Standard Deviation 6.49 |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points | Day 3: 0.5 hour, n=0,6,0,0,2 | 103.0 Percent predicted FEV1 | Standard Deviation 5.97 |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points | Day 3: 4 hours, n=0,6,0,12,4 | 106.7 Percent predicted FEV1 | Standard Deviation 7 |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points | Day 3: pre-dose, n=0,6,0,12,4 | 103.2 Percent predicted FEV1 | Standard Deviation 5.71 |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points | Day 8: pre-dose, n=0,0,6,0,2 | 105.0 Percent predicted FEV1 | Standard Deviation 5.73 |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points | Day 8: 4 hours, n=0,0,6,0,2 | 104.7 Percent predicted FEV1 | Standard Deviation 4.5 |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points | Day 11: pre-dose, n=0,0,6,12,4 | 103.3 Percent predicted FEV1 | Standard Deviation 3.88 |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points | Day 11: 4 hours, n=0,0,6,12,4 | 105.0 Percent predicted FEV1 | Standard Deviation 6.69 |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points | Day 16: pre-dose, n=0,0,6,0,2 | 102.5 Percent predicted FEV1 | Standard Deviation 5.32 |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points | Day 16: 4 hours, n=0,0,6,0,2 | 105.3 Percent predicted FEV1 | Standard Deviation 6.38 |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points | Day 19: pre-dose, n=0,0,6,0,2 | 101.7 Percent predicted FEV1 | Standard Deviation 7.47 |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points | Day 19: 0.25 hour, n=0,0,6,0,2 | 102.5 Percent predicted FEV1 | Standard Deviation 6.72 |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points | Day 19: 0.5 hour, n=0,0,6,0,2 | 102.7 Percent predicted FEV1 | Standard Deviation 10.09 |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points | Day 19: 1 hour, n=0,0,6,0,2 | 99.3 Percent predicted FEV1 | Standard Deviation 9.29 |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points | Day 19: 4 hours, n=0,0,6,0,2 | 104.0 Percent predicted FEV1 | Standard Deviation 6.78 |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points | Day 6: pre-dose, n=0,0,6,12,4 | 104.5 Percent predicted FEV1 | Standard Deviation 5.61 |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points | Day 6: 0.25 hour, n=0,0,6,0,2 | 102.3 Percent predicted FEV1 | Standard Deviation 6.8 |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points | Day 6: 0.5 hour, n=0,0,6,0,2 | 103.5 Percent predicted FEV1 | Standard Deviation 7.31 |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points | Day 6: 1 hour, n=0,0,6,0,2 | 104.0 Percent predicted FEV1 | Standard Deviation 6.26 |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points | Day 6: 4 hours, n=0,0,6,12,4 | 106.3 Percent predicted FEV1 | Standard Deviation 3.93 |
| Part 1: Cohort A- Placebo | Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points | Day 6: 4 hours, n=0,0,6,12,4 | 104.0 Percent predicted FEV1 | Standard Deviation 15.5 |
| Part 1: Cohort A- Placebo | Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points | Day 3: pre-dose, n=0,6,0,12,4 | 101.5 Percent predicted FEV1 | Standard Deviation 14.47 |
| Part 1: Cohort A- Placebo | Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points | Day 14: 4 hours, n=0,0,0,12,2 | 97.3 Percent predicted FEV1 | Standard Deviation 16.23 |
| Part 1: Cohort A- Placebo | Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points | Day 14: 1 hour, n=0,0,0,12,2 | 99.1 Percent predicted FEV1 | Standard Deviation 16.09 |
| Part 1: Cohort A- Placebo | Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points | Day 1: 4 hours, n=6,0,0,12,4 | 101.4 Percent predicted FEV1 | Standard Deviation 16.2 |
| Part 1: Cohort A- Placebo | Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points | Day 1: 0.5 hour, n=6,0,0,12,4 | 100.3 Percent predicted FEV1 | Standard Deviation 13.94 |
| Part 1: Cohort A- Placebo | Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points | Day 11: 4 hours, n=0,0,6,12,4 | 103.6 Percent predicted FEV1 | Standard Deviation 15.84 |
| Part 1: Cohort A- Placebo | Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points | Day 14: 0.5 hour, n=0,0,0,11,2 | 100.7 Percent predicted FEV1 | Standard Deviation 15.88 |
| Part 1: Cohort A- Placebo | Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points | Day 6: pre-dose, n=0,0,6,12,4 | 101.3 Percent predicted FEV1 | Standard Deviation 15.69 |
| Part 1: Cohort A- Placebo | Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points | Day 1: pre-dose, n=6,0,0,12,4 | 101.1 Percent predicted FEV1 | Standard Deviation 15.31 |
| Part 1: Cohort A- Placebo | Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points | Day 1: 1 hour, n=6,0,0,12,4 | 102.2 Percent predicted FEV1 | Standard Deviation 14.86 |
| Part 1: Cohort A- Placebo | Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points | Day 14: pre-dose, n=0,0,0,11,2 | 101.0 Percent predicted FEV1 | Standard Deviation 16.84 |
| Part 1: Cohort A- Placebo | Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points | Day 11: pre-dose, n=0,0,6,12,4 | 101.6 Percent predicted FEV1 | Standard Deviation 16.76 |
| Part 1: Cohort A- Placebo | Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points | Day 3: 4 hours, n=0,6,0,12,4 | 103.1 Percent predicted FEV1 | Standard Deviation 15.64 |
| Part 1: Placebo | Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points | Day 19: 4 hours, n=0,0,6,0,2 | 103.0 Percent predicted FEV1 | Standard Deviation 15.56 |
| Part 1: Placebo | Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points | Day 8: 4 hours, n=0,0,6,0,2 | 103.5 Percent predicted FEV1 | Standard Deviation 17.68 |
| Part 1: Placebo | Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points | Day 1: pre-dose, n=6,0,0,12,4 | 102.0 Percent predicted FEV1 | Standard Deviation 9.35 |
| Part 1: Placebo | Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points | Day 1: 0.25 hour, n=6,0,0,0,2 | 99.0 Percent predicted FEV1 | Standard Deviation 14.14 |
| Part 1: Placebo | Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points | Day 1: 0.5 hour, n=6,0,0,12,4 | 102.5 Percent predicted FEV1 | Standard Deviation 12.82 |
| Part 1: Placebo | Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points | Day 1: 1 hour, n=6,0,0,12,4 | 103.8 Percent predicted FEV1 | Standard Deviation 11.56 |
| Part 1: Placebo | Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points | Day 1: 4 hours, n=6,0,0,12,4 | 104.3 Percent predicted FEV1 | Standard Deviation 11.76 |
| Part 1: Placebo | Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points | Day 3: pre-dose, n=0,6,0,12,4 | 105.3 Percent predicted FEV1 | Standard Deviation 12.45 |
| Part 1: Placebo | Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points | Day 3: 0.25 hour, n=0,6,0,0,2 | 102.5 Percent predicted FEV1 | Standard Deviation 19.09 |
| Part 1: Placebo | Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points | Day 3: 0.5 hour, n=0,6,0,0,2 | 100.0 Percent predicted FEV1 | Standard Deviation 18.38 |
| Part 1: Placebo | Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points | Day 3: 1 hour, n=0,6,0,0,2 | 101.0 Percent predicted FEV1 | Standard Deviation 16.97 |
| Part 1: Placebo | Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points | Day 3: 4 hours, n=0,6,0,12,4 | 106.8 Percent predicted FEV1 | Standard Deviation 12.95 |
| Part 1: Placebo | Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points | Day 6: pre-dose, n=0,0,6,12,4 | 102.8 Percent predicted FEV1 | Standard Deviation 10.94 |
| Part 1: Placebo | Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points | Day 6: 0.5 hour, n=0,0,6,0,2 | 101.0 Percent predicted FEV1 | Standard Deviation 18.38 |
| Part 1: Placebo | Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points | Day 6: 1 hour, n=0,0,6,0,2 | 99.0 Percent predicted FEV1 | Standard Deviation 18.38 |
| Part 1: Placebo | Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points | Day 6: 4 hours, n=0,0,6,12,4 | 105.5 Percent predicted FEV1 | Standard Deviation 10.66 |
| Part 1: Placebo | Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points | Day 8: pre-dose, n=0,0,6,0,2 | 103.0 Percent predicted FEV1 | Standard Deviation 16.97 |
| Part 1: Placebo | Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points | Day 11: pre-dose, n=0,0,6,12,4 | 106.0 Percent predicted FEV1 | Standard Deviation 11.28 |
| Part 1: Placebo | Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points | Day 11: 4 hours, n=0,0,6,12,4 | 107.0 Percent predicted FEV1 | Standard Deviation 10.42 |
| Part 1: Placebo | Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points | Day 14: pre-dose, n=0,0,0,11,2 | 105.5 Percent predicted FEV1 | Standard Deviation 6.36 |
| Part 1: Placebo | Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points | Day 14: 0.5 hour, n=0,0,0,11,2 | 104.0 Percent predicted FEV1 | Standard Deviation 8.49 |
| Part 1: Placebo | Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points | Day 14: 1 hour, n=0,0,0,12,2 | 107.5 Percent predicted FEV1 | Standard Deviation 6.36 |
| Part 1: Placebo | Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points | Day 14: 4 hours, n=0,0,0,12,2 | 112.5 Percent predicted FEV1 | Standard Deviation 9.19 |
| Part 1: Placebo | Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points | Day 16: pre-dose, n=0,0,6,0,2 | 104.5 Percent predicted FEV1 | Standard Deviation 17.68 |
| Part 1: Placebo | Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points | Day 16: 4 hours, n=0,0,6,0,2 | 104.0 Percent predicted FEV1 | Standard Deviation 19.8 |
| Part 1: Placebo | Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points | Day 19: pre-dose, n=0,0,6,0,2 | 104.0 Percent predicted FEV1 | Standard Deviation 18.38 |
| Part 1: Placebo | Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points | Day 19: 0.25 hour, n=0,0,6,0,2 | 99.5 Percent predicted FEV1 | Standard Deviation 20.51 |
| Part 1: Placebo | Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points | Day 19: 0.5 hour, n=0,0,6,0,2 | 103.0 Percent predicted FEV1 | Standard Deviation 18.38 |
| Part 1: Placebo | Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points | Day 19: 1 hour, n=0,0,6,0,2 | 103.5 Percent predicted FEV1 | Standard Deviation 16.26 |
| Part 1: Placebo | Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points | Day 6: 0.25 hour, n=0,0,6,0,2 | 101.5 Percent predicted FEV1 | Standard Deviation 17.68 |
Primary
Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points
FVC is a measure of lung function and the maximal amount of air that can be forcefully exhaled in one second. FVC was measured using standard spirometry. Percent predicted FVC was calculated as: Percent predicted FVC=(maximum FVC divided by predicted normal FVC)\*100.
Time frame: Days 1, 3, 6 and 19: pre-dose, 0.25, 0.5, 1 and 4 hours post-dose; Days 8, 11 and 16: pre-dose and 4 hours post-dose; Day 14: pre-dose, 0.5, 1 and 4 hours post-dose
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). The primary aim was to compare the safety profiles of the different active doses; hence, placebo arms have been combined as pre-specified in reporting and analysis plan.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points | Day 1: 0.25 hour, n=6,0,0,0,2 | 101.5 Percent predicted FVC | Standard Deviation 8.41 |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points | Day 1: pre-dose, n=6,0,0,12,4 | 101.2 Percent predicted FVC | Standard Deviation 7.14 |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points | Day 1: 4 hours, n=6,0,0,12,4 | 106.7 Percent predicted FVC | Standard Deviation 8.94 |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points | Day 1: 1 hour, n=6,0,0,12,4 | 109.8 Percent predicted FVC | Standard Deviation 7.96 |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points | Day 1: 0.5 hour, n=6,0,0,12,4 | 108.3 Percent predicted FVC | Standard Deviation 7.31 |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points | Day 3: pre-dose, n=0,6,0,12,4 | 104.3 Percent predicted FVC | Standard Deviation 6.92 |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points | Day 3: 4 hours, n=0,6,0,12,4 | 106.5 Percent predicted FVC | Standard Deviation 6.72 |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points | Day 3: 0.5 hour, n=0,6,0,0,2 | 105.0 Percent predicted FVC | Standard Deviation 8 |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points | Day 3: 0.25 hour, n=0,6,0,0,2 | 105.7 Percent predicted FVC | Standard Deviation 8.5 |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points | Day 3: 1 hour, n=0,6,0,0,2 | 105.8 Percent predicted FVC | Standard Deviation 8.01 |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points | Day 11: pre-dose, n=0,0,6,12,4 | 107.2 Percent predicted FVC | Standard Deviation 7.41 |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points | Day 19: 4 hours, n=0,0,6,0,2 | 101.0 Percent predicted FVC | Standard Deviation 8.88 |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points | Day 6: 0.5 hour, n=0,0,6,0,2 | 105.7 Percent predicted FVC | Standard Deviation 9.81 |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points | Day 6: 1 hour, n=0,0,6,0,2 | 106.0 Percent predicted FVC | Standard Deviation 9.14 |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points | Day 8: pre-dose, n=0,0,6,0,2 | 108.8 Percent predicted FVC | Standard Deviation 8.47 |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points | Day 8: 4 hours, n=0,0,6,0,2 | 108.2 Percent predicted FVC | Standard Deviation 8.47 |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points | Day 11: 4 hours, n=0,0,6,12,4 | 107.8 Percent predicted FVC | Standard Deviation 8.86 |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points | Day 19: 1 hour, n=0,0,6,0,2 | 100.8 Percent predicted FVC | Standard Deviation 11.84 |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points | Day 19: 0.5 hour, n=0,0,6,0,2 | 104.3 Percent predicted FVC | Standard Deviation 10.73 |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points | Day 16: 4 hours, n=0,0,6,0,2 | 108.5 Percent predicted FVC | Standard Deviation 8.38 |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points | Day 6: pre-dose, n=0,0,6,12,4 | 107.8 Percent predicted FVC | Standard Deviation 7.08 |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points | Day 16: pre-dose, n=0,0,6,0,2 | 107.7 Percent predicted FVC | Standard Deviation 8.04 |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points | Day 6: 0.25 hour, n=0,0,6,0,2 | 104.7 Percent predicted FVC | Standard Deviation 8.33 |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points | Day 19: 0.25 hour, n=0,0,6,0,2 | 105.7 Percent predicted FVC | Standard Deviation 10.07 |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points | Day 6: 4 hours, n=0,0,6,12,4 | 110.2 Percent predicted FVC | Standard Deviation 7.08 |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points | Day 19: pre-dose, n=0,0,6,0,2 | 104.0 Percent predicted FVC | Standard Deviation 10.32 |
| Part 1: Cohort A- Placebo | Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points | Day 1: 4 hours, n=6,0,0,12,4 | 103.4 Percent predicted FVC | Standard Deviation 14.74 |
| Part 1: Cohort A- Placebo | Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points | Day 3: pre-dose, n=0,6,0,12,4 | 105.0 Percent predicted FVC | Standard Deviation 14.68 |
| Part 1: Cohort A- Placebo | Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points | Day 6: 4 hours, n=0,0,6,12,4 | 105.4 Percent predicted FVC | Standard Deviation 14.85 |
| Part 1: Cohort A- Placebo | Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points | Day 6: pre-dose, n=0,0,6,12,4 | 103.7 Percent predicted FVC | Standard Deviation 14.77 |
| Part 1: Cohort A- Placebo | Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points | Day 11: pre-dose, n=0,0,6,12,4 | 104.3 Percent predicted FVC | Standard Deviation 17.05 |
| Part 1: Cohort A- Placebo | Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points | Day 11: 4 hours, n=0,0,6,12,4 | 106.3 Percent predicted FVC | Standard Deviation 17.43 |
| Part 1: Cohort A- Placebo | Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points | Day 14: pre-dose, n=0,0,0,11,2 | 104.7 Percent predicted FVC | Standard Deviation 16.01 |
| Part 1: Cohort A- Placebo | Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points | Day 14: 0.5 hour, n=0,0,0,11,2 | 103.6 Percent predicted FVC | Standard Deviation 14.52 |
| Part 1: Cohort A- Placebo | Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points | Day 14: 1 hour, n=0,0,0,12,2 | 100.8 Percent predicted FVC | Standard Deviation 14.91 |
| Part 1: Cohort A- Placebo | Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points | Day 14: 4 hours, n=0,0,0,11,2 | 99.0 Percent predicted FVC | Standard Deviation 16.81 |
| Part 1: Cohort A- Placebo | Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points | Day 1: pre-dose, n=6,0,0,12,4 | 104.1 Percent predicted FVC | Standard Deviation 14.19 |
| Part 1: Cohort A- Placebo | Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points | Day 1: 0.5 hour, n=6,0,0,12,4 | 102.4 Percent predicted FVC | Standard Deviation 13.28 |
| Part 1: Cohort A- Placebo | Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points | Day 1: 1 hour, n=6,0,0,12,4 | 103.7 Percent predicted FVC | Standard Deviation 13.66 |
| Part 1: Cohort A- Placebo | Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points | Day 3: 4 hours, n=0,6,0,12,4 | 105.3 Percent predicted FVC | Standard Deviation 14.91 |
| Part 1: Placebo | Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points | Day 16: 4 hours, n=0,0,6,0,2 | 110.5 Percent predicted FVC | Standard Deviation 6.36 |
| Part 1: Placebo | Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points | Day 11: 4 hours, n=0,0,6,12,4 | 107.0 Percent predicted FVC | Standard Deviation 5.35 |
| Part 1: Placebo | Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points | Day 3: 0.25 hour, n=0,6,0,0,2 | 106.5 Percent predicted FVC | Standard Deviation 3.54 |
| Part 1: Placebo | Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points | Day 1: pre-dose, n=6,0,0,12,4 | 102.0 Percent predicted FVC | Standard Deviation 2.58 |
| Part 1: Placebo | Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points | Day 8: 4 hours, n=0,0,6,0,2 | 108.0 Percent predicted FVC | Standard Deviation 2.83 |
| Part 1: Placebo | Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points | Day 1: 0.25 hour, n=6,0,0,0,2 | 102.0 Percent predicted FVC | Standard Deviation 5.66 |
| Part 1: Placebo | Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points | Day 8: pre-dose, n=0,0,6,0,2 | 108.0 Percent predicted FVC | Standard Deviation 1.41 |
| Part 1: Placebo | Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points | Day 19: 1 hour, n=0,0,6,0,2 | 103.5 Percent predicted FVC | Standard Deviation 6.36 |
| Part 1: Placebo | Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points | Day 1: 0.5 hour, n=6,0,0,12,4 | 103.8 Percent predicted FVC | Standard Deviation 2.87 |
| Part 1: Placebo | Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points | Day 6: 4 hours, n=0,0,6,12,4 | 104.8 Percent predicted FVC | Standard Deviation 3.3 |
| Part 1: Placebo | Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points | Day 1: 4 hours, n=6,0,0,12,4 | 104.5 Percent predicted FVC | Standard Deviation 4.36 |
| Part 1: Placebo | Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points | Day 1: 1 hour, n=6,0,0,12,4 | 105.3 Percent predicted FVC | Standard Deviation 2.5 |
| Part 1: Placebo | Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points | Day 6: 1 hour, n=0,0,6,0,2 | 99.5 Percent predicted FVC | Standard Deviation 10.61 |
| Part 1: Placebo | Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points | Day 3: pre-dose, n=0,6,0,12,4 | 105.8 Percent predicted FVC | Standard Deviation 2.63 |
| Part 1: Placebo | Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points | Day 6: 0.5 hour, n=0,0,6,0,2 | 103.5 Percent predicted FVC | Standard Deviation 2.12 |
| Part 1: Placebo | Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points | Day 3: 0.5 hour, n=0,6,0,0,2 | 104.5 Percent predicted FVC | Standard Deviation 3.54 |
| Part 1: Placebo | Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points | Day 6: pre-dose, n=0,0,6,12,4 | 103.3 Percent predicted FVC | Standard Deviation 2.22 |
| Part 1: Placebo | Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points | Day 3: 1 hour, n=0,6,0,0,2 | 105.0 Percent predicted FVC | Standard Deviation 1.41 |
| Part 1: Placebo | Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points | Day 14: 1 hour, n=0,0,0,12,2 | 104.0 Percent predicted FVC | Standard Deviation 1.41 |
| Part 1: Placebo | Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points | Day 19: 4 hours, n=0,0,6,0,2 | 101.5 Percent predicted FVC | Standard Deviation 6.36 |
| Part 1: Placebo | Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points | Day 11: pre-dose, n=0,0,6,12,4 | 106.8 Percent predicted FVC | Standard Deviation 6.13 |
| Part 1: Placebo | Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points | Day 19: pre-dose, n=0,0,6,0,2 | 110.0 Percent predicted FVC | Standard Deviation 4.24 |
| Part 1: Placebo | Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points | Day 6: 0.25 hour, n=0,0,6,0,2 | 104.5 Percent predicted FVC | Standard Deviation 2.12 |
| Part 1: Placebo | Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points | Day 19: 0.25 hour, n=0,0,6,0,2 | 107.0 Percent predicted FVC | Standard Deviation 7.07 |
| Part 1: Placebo | Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points | Day 3: 4 hours, n=0,6,0,12,4 | 105.0 Percent predicted FVC | Standard Deviation 2.16 |
| Part 1: Placebo | Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points | Day 19: 0.5 hour, n=0,0,6,0,2 | 106.5 Percent predicted FVC | Standard Deviation 7.78 |
| Part 1: Placebo | Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points | Day 14: 4 hours, n=0,0,0,11,2 | 106.0 Percent predicted FVC | Standard Deviation 0 |
| Part 1: Placebo | Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points | Day 14: 0.5 hour, n=0,0,0,11,2 | 100.5 Percent predicted FVC | Standard Deviation 0.71 |
| Part 1: Placebo | Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points | Day 16: pre-dose, n=0,0,6,0,2 | 111.0 Percent predicted FVC | Standard Deviation 4.24 |
| Part 1: Placebo | Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points | Day 14: pre-dose, n=0,0,0,11,2 | 102.5 Percent predicted FVC | Standard Deviation 3.54 |
Primary
Part 1: pH Value by Visit- Placebo
Urine samples were collected from participants at indicated time points for analysis of pH. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).
Time frame: Baseline (Day -1), Days 2, 5, 7, 12, 15 and 22
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). The primary aim was to compare the safety profiles of the different active doses; hence, placebo arms have been combined as pre-specified in reporting and analysis plan.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: pH Value by Visit- Placebo | Baseline: n=4 | 6.50 pH | Standard Deviation 0.707 |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: pH Value by Visit- Placebo | Day 2: n=2 | 5.50 pH | Standard Deviation 0.707 |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: pH Value by Visit- Placebo | Day 5: n=2 | 6.25 pH | Standard Deviation 0.354 |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: pH Value by Visit- Placebo | Day 7: n=2 | 7.00 pH | Standard Deviation 1.414 |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: pH Value by Visit- Placebo | Day 12: n=2 | 5.75 pH | Standard Deviation 1.061 |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: pH Value by Visit- Placebo | Day 15: n=2 | 5.50 pH | Standard Deviation 0.707 |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: pH Value by Visit- Placebo | Day 22: n=2 | 6.75 pH | Standard Deviation 1.061 |
Primary
Part 1: Specific Gravity Value by Visit- Placebo
Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected from participants at indicated time points for analysis of Specific gravity. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).
Time frame: Baseline (Day -1), Days 2, 5, 7, 12, 15 and 22
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). The primary aim was to compare the safety profiles of the different active doses; hence, placebo arms have been combined as pre-specified in reporting and analysis plan.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Specific Gravity Value by Visit- Placebo | Baseline: n=4 | 1.0148 Ratio | Standard Deviation 0.00858 |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Specific Gravity Value by Visit- Placebo | Day 2: n=2 | 1.0150 Ratio | Standard Deviation 0 |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Specific Gravity Value by Visit- Placebo | Day 5: n=2 | 1.0150 Ratio | Standard Deviation 0.00707 |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Specific Gravity Value by Visit- Placebo | Day 7: n=2 | 1.0150 Ratio | Standard Deviation 0.00707 |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Specific Gravity Value by Visit- Placebo | Day 12: n=2 | 1.0120 Ratio | Standard Deviation 0.01131 |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Specific Gravity Value by Visit- Placebo | Day 15: n=2 | 1.0150 Ratio | Standard Deviation 0.00707 |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Specific Gravity Value by Visit- Placebo | Day 22: n=2 | 1.0095 Ratio | Standard Deviation 0.00778 |
Primary
Part 2 Cohort A: AUC(0-infinity) After Single Dose Administration of CCI15106 60 mg on Day 1
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of AUC(0-infinity) data.
Time frame: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose
Population: PK Population. Only those participants with data available at the indicated time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Cohort A- CCI15106 60 mg SD | Part 2 Cohort A: AUC(0-infinity) After Single Dose Administration of CCI15106 60 mg on Day 1 | 968.8838 Hours*nanogram per milliliter | Geometric Coefficient of Variation 49.4 |
Primary
Part 2 Cohort A: AUC(0-t) After Single Dose Administration of CCI15106 60 mg on Day 1
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of AUC(0-t) data.
Time frame: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose
Population: PK Population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Cohort A- CCI15106 60 mg SD | Part 2 Cohort A: AUC(0-t) After Single Dose Administration of CCI15106 60 mg on Day 1 | 862.7642 Hours*nanogram per milliliter | Geometric Coefficient of Variation 59.1 |
Primary
Part 2 Cohort A: CL/F After Single Dose Administration of CCI15106 60 mg on Day 1
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of CL/F data.
Time frame: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose
Population: PK Population. Only those participants with data available at the indicated time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Cohort A- CCI15106 60 mg SD | Part 2 Cohort A: CL/F After Single Dose Administration of CCI15106 60 mg on Day 1 | 61.9269 Liters per hour | Geometric Coefficient of Variation 49.4 |
Primary
Part 2 Cohort A: Cmax After Single Dose Administration of CCI15106 60 mg on Day 1
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of Cmax data.
Time frame: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose
Population: PK Population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Cohort A- CCI15106 60 mg SD | Part 2 Cohort A: Cmax After Single Dose Administration of CCI15106 60 mg on Day 1 | 179.3 Nanogram per milliliter | Geometric Coefficient of Variation 81.3 |
Primary
Part 2 Cohort A: Number of Participants With NSAEs and SAEs
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is 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.
Time frame: Up to 33 days
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: Cohort A- CCI15106 60 mg SD | Part 2 Cohort A: Number of Participants With NSAEs and SAEs | NSAEs | 0 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 2 Cohort A: Number of Participants With NSAEs and SAEs | SAEs | 0 Participants |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 2 Cohort A: Number of Participants With NSAEs and SAEs | NSAEs | 0 Participants |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 2 Cohort A: Number of Participants With NSAEs and SAEs | SAEs | 0 Participants |
Primary
Part 2 Cohort A: pH Value by Visit- CCI15106
Urine samples were collected from participants at indicated time points for analysis of pH. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).
Time frame: Baseline (Day -1) and Day 2
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Cohort A- CCI15106 60 mg SD | Part 2 Cohort A: pH Value by Visit- CCI15106 | Baseline | 6.25 pH | Standard Deviation 0.822 |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 2 Cohort A: pH Value by Visit- CCI15106 | Day 2 | 6.58 pH | Standard Deviation 0.801 |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 2 Cohort A: pH Value by Visit- CCI15106 | Day 2 | 6.50 pH | Standard Deviation 0.707 |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 2 Cohort A: pH Value by Visit- CCI15106 | Baseline | 6.75 pH | Standard Deviation 1.061 |
Primary
Part 2 Cohort A: Specific Gravity Value by Visit- CCI15106
Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected from participants at indicated time points for analysis of specific gravity. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).
Time frame: Baseline (Day -1) and Day 2
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Cohort A- CCI15106 60 mg SD | Part 2 Cohort A: Specific Gravity Value by Visit- CCI15106 | Baseline | 1.0205 Ratio | Standard Deviation 0.01694 |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 2 Cohort A: Specific Gravity Value by Visit- CCI15106 | Day 2 | 1.0147 Ratio | Standard Deviation 0.00737 |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 2 Cohort A: Specific Gravity Value by Visit- CCI15106 | Baseline | 1.0175 Ratio | Standard Deviation 0.01061 |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 2 Cohort A: Specific Gravity Value by Visit- CCI15106 | Day 2 | 1.0275 Ratio | Standard Deviation 0.01768 |
Primary
Part 2 Cohort A: t1/2 After Single Dose Administration of CCI15106 60 mg on Day 1
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of t1/2 data.
Time frame: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose
Population: PK Population. Only those participants with data available at the indicated time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Cohort A- CCI15106 60 mg SD | Part 2 Cohort A: t1/2 After Single Dose Administration of CCI15106 60 mg on Day 1 | 16.4000 Hours | Geometric Coefficient of Variation 8.3 |
Primary
Part 2 Cohort A: Tmax After Single Dose Administration of CCI15106 60 mg on Day 1
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of tmax data.
Time frame: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose
Population: PK Population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: Cohort A- CCI15106 60 mg SD | Part 2 Cohort A: Tmax After Single Dose Administration of CCI15106 60 mg on Day 1 | 0.500 Hours |
Primary
Part 2 Cohort B: AUC(0-tau) After Repeated Dose Administration of CCI15106 60 mg
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of AUC(0-tau) data.
Time frame: Days 1 and 14: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose
Population: PK Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Cohort A- CCI15106 60 mg SD | Part 2 Cohort B: AUC(0-tau) After Repeated Dose Administration of CCI15106 60 mg | Day 1, n=8 | 687.0875 Hours*nanogram per milliliter | Geometric Coefficient of Variation 39.8 |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 2 Cohort B: AUC(0-tau) After Repeated Dose Administration of CCI15106 60 mg | Day 14, n=7 | 3086.5172 Hours*nanogram per milliliter | Geometric Coefficient of Variation 28.1 |
Primary
Part 2 Cohort B: Cmax After Repeated Dose Administration of CCI15106 60 mg
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of Cmax data.
Time frame: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day14: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose
Population: PK Population. Only those participants with data available at the indicated time points were analyzed.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Cohort A- CCI15106 60 mg SD | Part 2 Cohort B: Cmax After Repeated Dose Administration of CCI15106 60 mg | Day 1 | 178.2 Nanogram per milliliter | Geometric Coefficient of Variation 51.4 |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 2 Cohort B: Cmax After Repeated Dose Administration of CCI15106 60 mg | Day 14 | 423.0 Nanogram per milliliter | Geometric Coefficient of Variation 31.9 |
Primary
Part 2 Cohort B: Number of Participants With NSAEs and SAEs
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is 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.
Time frame: Up to 46 days
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: Cohort A- CCI15106 60 mg SD | Part 2 Cohort B: Number of Participants With NSAEs and SAEs | SAEs | 0 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 2 Cohort B: Number of Participants With NSAEs and SAEs | NSAEs | 7 Participants |
Primary
Part 2 Cohort B: pH Value by Visit- CCI15106 60 mg BID
Urine samples were collected from participants at indicated time points for analysis of pH. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).
Time frame: Baseline (Day -1), Days 7 and 15
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Cohort A- CCI15106 60 mg SD | Part 2 Cohort B: pH Value by Visit- CCI15106 60 mg BID | Baseline | 6.13 pH | Standard Deviation 0.916 |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 2 Cohort B: pH Value by Visit- CCI15106 60 mg BID | Day 7 | 5.94 pH | Standard Deviation 0.863 |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 2 Cohort B: pH Value by Visit- CCI15106 60 mg BID | Day 15 | 5.81 pH | Standard Deviation 0.884 |
Primary
Part 2 Cohort B: Specific Gravity Value by Visit- CCI15106 60 mg BID
Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected from participants at indicated time points for analysis of specific gravity. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).
Time frame: Baseline (Day -1), Days 7 and 15
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Cohort A- CCI15106 60 mg SD | Part 2 Cohort B: Specific Gravity Value by Visit- CCI15106 60 mg BID | Baseline | 1.0106 Ratio | Standard Deviation 0.00678 |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 2 Cohort B: Specific Gravity Value by Visit- CCI15106 60 mg BID | Day 7 | 1.0114 Ratio | Standard Deviation 0.00424 |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 2 Cohort B: Specific Gravity Value by Visit- CCI15106 60 mg BID | Day 15 | 1.0133 Ratio | Standard Deviation 0.00523 |
Primary
Part 2 Cohort B: t1/2 After Repeated Dose Administration of CCI15106 60 mg
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of t1/2 data.
Time frame: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day14: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose
Population: PK Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Cohort A- CCI15106 60 mg SD | Part 2 Cohort B: t1/2 After Repeated Dose Administration of CCI15106 60 mg | Day 1, n=8 | 8.1572 Hours | Geometric Coefficient of Variation 18 |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 2 Cohort B: t1/2 After Repeated Dose Administration of CCI15106 60 mg | Day 14, n=7 | 21.5034 Hours | Geometric Coefficient of Variation 39.6 |
Primary
Part 2 Cohort B: Tmax After Repeated Dose Administration of CCI15106 60 mg
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of tmax data.
Time frame: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day14: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose
Population: PK Population.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part 1: Cohort A- CCI15106 60 mg SD | Part 2 Cohort B: Tmax After Repeated Dose Administration of CCI15106 60 mg | Day 1 | 0.633 Hours |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 2 Cohort B: Tmax After Repeated Dose Administration of CCI15106 60 mg | Day 14 | 0.500 Hours |
Primary
Part 2: Number of Participants With Abnormal Telemetry Findings
Continuous cardiac telemetry was performed from approximately 0.5 hour (pre-dose) to 4 hours post-dose. Abnormal findings were categorized as CS and NCS. 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.
Time frame: Days 1, 7, 12 and 13: 0.5 hour (pre-dose) to 4 hours post-dose
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: Cohort A- CCI15106 60 mg SD | Part 2: Number of Participants With Abnormal Telemetry Findings | Day 1: 0.5 to 4 hours post-dose-NCS; n=6,2,8 | 0 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 2: Number of Participants With Abnormal Telemetry Findings | Day 1: 0.5 to 4 hours post-dose-CS; n=6,2,8 | 0 Participants |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 2: Number of Participants With Abnormal Telemetry Findings | Day 1: 0.5 to 4 hours post-dose-CS; n=6,2,8 | 0 Participants |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 2: Number of Participants With Abnormal Telemetry Findings | Day 1: 0.5 to 4 hours post-dose-NCS; n=6,2,8 | 0 Participants |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 2: Number of Participants With Abnormal Telemetry Findings | Day 7: 0.5 to 4 hours post-dose-NCS; n=0,0,8 | 2 Participants |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 2: Number of Participants With Abnormal Telemetry Findings | Day 12: 0.5 to 4 hours post-dose-CS; n=0,0,5 | 0 Participants |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 2: Number of Participants With Abnormal Telemetry Findings | Day 12: 0.5 to 4 hours post-dose-NCS; n=0,0,5 | 0 Participants |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 2: Number of Participants With Abnormal Telemetry Findings | Day 13: 0.5 to 4 hours post-dose-CS; n=0,0,3 | 0 Participants |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 2: Number of Participants With Abnormal Telemetry Findings | Day 13: 0.5 to 4 hours post-dose-NCS; n=0,0,3 | 1 Participants |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 2: Number of Participants With Abnormal Telemetry Findings | Day 1: 0.5 to 4 hours post-dose-CS; n=6,2,8 | 0 Participants |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 2: Number of Participants With Abnormal Telemetry Findings | Day 1: 0.5 to 4 hours post-dose-NCS; n=6,2,8 | 1 Participants |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 2: Number of Participants With Abnormal Telemetry Findings | Day 7: 0.5 to 4 hours post-dose-CS; n=0,0,8 | 0 Participants |
Primary
Part 2: Number of Participants With Clinical Chemistry Values of PCI
PCI ranges for the clinical chemistry parameters were as follows: albumin (low: \<30 mmol/L), calcium (low: \<2 mmol/L and high: \>2.75 mmol/L), glucose (low: \<3 mmol/L and high: \>9 mmol/L), potassium (low: \<3 mmol/L and high: \>5.5 mmol/L) and sodium (low: \<130 mmol/L and high: \>150 mmol/L). Data for the participants with high and low values has been reported.
Time frame: Up to 46 days
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: Cohort A- CCI15106 60 mg SD | Part 2: Number of Participants With Clinical Chemistry Values of PCI | Potassium: high | 0 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 2: Number of Participants With Clinical Chemistry Values of PCI | Sodium: low | 0 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 2: Number of Participants With Clinical Chemistry Values of PCI | Calcium: high | 0 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 2: Number of Participants With Clinical Chemistry Values of PCI | Sodium: high | 0 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 2: Number of Participants With Clinical Chemistry Values of PCI | Glucose: low | 0 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 2: Number of Participants With Clinical Chemistry Values of PCI | Albumin: low | 0 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 2: Number of Participants With Clinical Chemistry Values of PCI | Glucose: high | 0 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 2: Number of Participants With Clinical Chemistry Values of PCI | Calcium: low | 0 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 2: Number of Participants With Clinical Chemistry Values of PCI | Potassium: low | 0 Participants |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 2: Number of Participants With Clinical Chemistry Values of PCI | Glucose: high | 0 Participants |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 2: Number of Participants With Clinical Chemistry Values of PCI | Potassium: high | 0 Participants |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 2: Number of Participants With Clinical Chemistry Values of PCI | Albumin: low | 0 Participants |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 2: Number of Participants With Clinical Chemistry Values of PCI | Glucose: low | 0 Participants |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 2: Number of Participants With Clinical Chemistry Values of PCI | Sodium: low | 0 Participants |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 2: Number of Participants With Clinical Chemistry Values of PCI | Potassium: low | 0 Participants |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 2: Number of Participants With Clinical Chemistry Values of PCI | Calcium: low | 0 Participants |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 2: Number of Participants With Clinical Chemistry Values of PCI | Sodium: high | 0 Participants |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 2: Number of Participants With Clinical Chemistry Values of PCI | Calcium: high | 0 Participants |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 2: Number of Participants With Clinical Chemistry Values of PCI | Sodium: high | 0 Participants |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 2: Number of Participants With Clinical Chemistry Values of PCI | Albumin: low | 0 Participants |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 2: Number of Participants With Clinical Chemistry Values of PCI | Calcium: low | 0 Participants |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 2: Number of Participants With Clinical Chemistry Values of PCI | Glucose: low | 0 Participants |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 2: Number of Participants With Clinical Chemistry Values of PCI | Glucose: high | 1 Participants |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 2: Number of Participants With Clinical Chemistry Values of PCI | Potassium: low | 0 Participants |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 2: Number of Participants With Clinical Chemistry Values of PCI | Potassium: high | 0 Participants |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 2: Number of Participants With Clinical Chemistry Values of PCI | Sodium: low | 0 Participants |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 2: Number of Participants With Clinical Chemistry Values of PCI | Calcium: high | 0 Participants |
Primary
Part 2: Number of Participants With Hematology Values of PCI
PCI ranges for the hematology parameters were as follows: hematocrit (high: \>0.54 proportion of RBC in blood for male, \>0.54 proportion of RBC in blood for female), hemoglobin (high: \>180 g/L in male, \>180 g/L in female), lymphocytes (low: \<0.8 10\^9/L), neutrophil count (low: \<1.5 10\^9/L) and platelet count (low: \<100 10\^9/L and high: 550 10\^9/L). Data for the participants with high and low values has been reported.
Time frame: Up to 46 days
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: Cohort A- CCI15106 60 mg SD | Part 2: Number of Participants With Hematology Values of PCI | Hematocrit: high | 0 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 2: Number of Participants With Hematology Values of PCI | Hemoglobin: high | 0 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 2: Number of Participants With Hematology Values of PCI | Lymphocytes: low | 0 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 2: Number of Participants With Hematology Values of PCI | Neutrophil count: low | 0 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 2: Number of Participants With Hematology Values of PCI | Platelet count: low | 0 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 2: Number of Participants With Hematology Values of PCI | Platelet count: high | 0 Participants |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 2: Number of Participants With Hematology Values of PCI | Platelet count: high | 0 Participants |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 2: Number of Participants With Hematology Values of PCI | Hematocrit: high | 0 Participants |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 2: Number of Participants With Hematology Values of PCI | Neutrophil count: low | 0 Participants |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 2: Number of Participants With Hematology Values of PCI | Platelet count: low | 0 Participants |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 2: Number of Participants With Hematology Values of PCI | Hemoglobin: high | 0 Participants |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 2: Number of Participants With Hematology Values of PCI | Lymphocytes: low | 0 Participants |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 2: Number of Participants With Hematology Values of PCI | Hemoglobin: high | 0 Participants |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 2: Number of Participants With Hematology Values of PCI | Lymphocytes: low | 0 Participants |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 2: Number of Participants With Hematology Values of PCI | Platelet count: high | 0 Participants |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 2: Number of Participants With Hematology Values of PCI | Neutrophil count: low | 0 Participants |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 2: Number of Participants With Hematology Values of PCI | Hematocrit: high | 0 Participants |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 2: Number of Participants With Hematology Values of PCI | Platelet count: low | 0 Participants |
Primary
Part 2: Number of Participants With Vital Signs Values of PCI
PCI ranges for the vital signs parameters were as follows: SBP \<85 and \>160 mmHg, DBP \<45 and \>100 mmHg and heart rate \<40 and \>110 bpm. Data for the participants with high and low values has been reported.
Time frame: Up to 46 days
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: Cohort A- CCI15106 60 mg SD | Part 2: Number of Participants With Vital Signs Values of PCI | DBP: low | 0 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 2: Number of Participants With Vital Signs Values of PCI | DBP: high | 0 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 2: Number of Participants With Vital Signs Values of PCI | Heart rate: high | 0 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 2: Number of Participants With Vital Signs Values of PCI | SBP: low | 0 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 2: Number of Participants With Vital Signs Values of PCI | SBP: high | 0 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 2: Number of Participants With Vital Signs Values of PCI | Heart rate: low | 0 Participants |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 2: Number of Participants With Vital Signs Values of PCI | Heart rate: low | 0 Participants |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 2: Number of Participants With Vital Signs Values of PCI | SBP: low | 0 Participants |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 2: Number of Participants With Vital Signs Values of PCI | Heart rate: high | 0 Participants |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 2: Number of Participants With Vital Signs Values of PCI | DBP: low | 0 Participants |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 2: Number of Participants With Vital Signs Values of PCI | SBP: high | 0 Participants |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 2: Number of Participants With Vital Signs Values of PCI | DBP: high | 0 Participants |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 2: Number of Participants With Vital Signs Values of PCI | DBP: low | 0 Participants |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 2: Number of Participants With Vital Signs Values of PCI | Heart rate: low | 0 Participants |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 2: Number of Participants With Vital Signs Values of PCI | SBP: high | 1 Participants |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 2: Number of Participants With Vital Signs Values of PCI | Heart rate: high | 0 Participants |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 2: Number of Participants With Vital Signs Values of PCI | DBP: high | 0 Participants |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 2: Number of Participants With Vital Signs Values of PCI | SBP: low | 0 Participants |
Primary
Part 2: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI
PCI ranges for the ECG parameters were as follows: absolute QTc interval \>450 and \<480, \>=480 and \<500, \>=500 msec, absolute PR interval \<110 and \>220 msec and absolute QRS interval \<75 and \>110 msec. Data for worst case post-Baseline has been reported.
Time frame: Up to 46 days
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: Cohort A- CCI15106 60 mg SD | Part 2: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI | QRS duration: 75<=Value<=110 | 5 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 2: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI | QT interval: Value<=450 | 6 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 2: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI | QTcF interval: Value<=450 | 6 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 2: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI | PR interval: Value>220 | 0 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 2: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI | QT interval: 450<Value<480 | 0 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 2: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI | QTcF interval: 480<=Value<500 | 0 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 2: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI | QT interval: 480<=Value<500 | 0 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 2: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI | QTcB interval: Value>=500 | 0 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 2: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI | QRS duration: Value>110 | 0 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 2: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI | QT interval: Value>=500 | 0 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 2: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI | QTcF interval: Value>=500 | 0 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 2: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI | PR interval: Value<110 | 1 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 2: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI | QTcB interval: Value<=450 | 5 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 2: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI | PR interval: 110<=Value<=220 | 5 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 2: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI | QRS duration: Value<75 | 1 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 2: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI | QTcB interval: 450<Value<480 | 1 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 2: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI | QTcF interval: 450<Value<480 | 0 Participants |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 2: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI | QTcB interval: 480<=Value<500 | 0 Participants |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 2: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI | QRS duration: Value<75 | 0 Participants |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 2: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI | QTcB interval: 480<=Value<500 | 0 Participants |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 2: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI | QTcB interval: Value>=500 | 0 Participants |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 2: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI | QTcF interval: Value<=450 | 2 Participants |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 2: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI | QRS duration: 75<=Value<=110 | 2 Participants |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 2: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI | QTcF interval: 450<Value<480 | 0 Participants |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 2: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI | PR interval: 110<=Value<=220 | 2 Participants |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 2: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI | QTcF interval: 480<=Value<500 | 0 Participants |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 2: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI | QTcF interval: Value>=500 | 0 Participants |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 2: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI | QRS duration: Value>110 | 0 Participants |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 2: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI | PR interval: Value<110 | 0 Participants |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 2: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI | QT interval: Value<=450 | 2 Participants |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 2: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI | QT interval: 450<Value<480 | 0 Participants |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 2: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI | QT interval: 480<=Value<500 | 0 Participants |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 2: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI | PR interval: Value>220 | 0 Participants |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 2: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI | QT interval: Value>=500 | 0 Participants |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 2: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI | QTcB interval: Value<=450 | 2 Participants |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 2: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI | QTcB interval: 450<Value<480 | 0 Participants |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 2: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI | QTcF interval: Value>=500 | 0 Participants |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 2: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI | PR interval: Value<110 | 0 Participants |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 2: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI | PR interval: 110<=Value<=220 | 8 Participants |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 2: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI | PR interval: Value>220 | 0 Participants |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 2: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI | QRS duration: Value<75 | 0 Participants |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 2: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI | QRS duration: 75<=Value<=110 | 7 Participants |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 2: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI | QRS duration: Value>110 | 1 Participants |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 2: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI | QT interval: Value<=450 | 8 Participants |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 2: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI | QT interval: 480<=Value<500 | 0 Participants |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 2: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI | QT interval: Value>=500 | 0 Participants |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 2: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI | QTcB interval: Value<=450 | 7 Participants |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 2: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI | QTcB interval: 450<Value<480 | 1 Participants |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 2: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI | QTcB interval: 480<=Value<500 | 0 Participants |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 2: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI | QTcB interval: Value>=500 | 0 Participants |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 2: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI | QTcF interval: Value<=450 | 7 Participants |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 2: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI | QTcF interval: 450<Value<480 | 1 Participants |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 2: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI | QTcF interval: 480<=Value<500 | 0 Participants |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 2: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI | QT interval: 450<Value<480 | 0 Participants |
Primary
Part 2: Percent Predicted FEV1 at Indicated Time Points
FEV1 is a measure of lung function and the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured using standard spirometry. Percent predicted FEV1 was calculated as: Percent predicted FEV1=(maximum FEV1 divided by predicted normal FEV1)\*100.
Time frame: Day 1 and 14: pre-dose, 0.25, 0.5, 1 and 4 hours post-dose; Days 3, 6 and 11: pre-dose and 4 hours post-dose
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Cohort A- CCI15106 60 mg SD | Part 2: Percent Predicted FEV1 at Indicated Time Points | Day 1: pre-dose, n=6,2,8 | 50.3 Percent predicted FEV1 | Standard Deviation 13.88 |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 2: Percent Predicted FEV1 at Indicated Time Points | Day 1: 0.25 hour, n=6,2,8 | 45.3 Percent predicted FEV1 | Standard Deviation 10.93 |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 2: Percent Predicted FEV1 at Indicated Time Points | Day 1: 0.5 hour, n=6,2,8 | 47.8 Percent predicted FEV1 | Standard Deviation 12.45 |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 2: Percent Predicted FEV1 at Indicated Time Points | Day 1: 1 hour, n=6,2,8 | 50.5 Percent predicted FEV1 | Standard Deviation 13.88 |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 2: Percent Predicted FEV1 at Indicated Time Points | Day 1: 4 hours, n=6,2,8 | 55.5 Percent predicted FEV1 | Standard Deviation 12.05 |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 2: Percent Predicted FEV1 at Indicated Time Points | Day 1: 0.5 hour, n=6,2,8 | 43.0 Percent predicted FEV1 | Standard Deviation 24.04 |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 2: Percent Predicted FEV1 at Indicated Time Points | Day 1: pre-dose, n=6,2,8 | 51.5 Percent predicted FEV1 | Standard Deviation 20.51 |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 2: Percent Predicted FEV1 at Indicated Time Points | Day 1: 1 hour, n=6,2,8 | 45.0 Percent predicted FEV1 | Standard Deviation 21.21 |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 2: Percent Predicted FEV1 at Indicated Time Points | Day 1: 4 hours, n=6,2,8 | 50.5 Percent predicted FEV1 | Standard Deviation 17.68 |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 2: Percent Predicted FEV1 at Indicated Time Points | Day 1: 0.25 hour, n=6,2,8 | 41.0 Percent predicted FEV1 | Standard Deviation 24.04 |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 2: Percent Predicted FEV1 at Indicated Time Points | Day 1: 1 hour, n=6,2,8 | 50.8 Percent predicted FEV1 | Standard Deviation 2.87 |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 2: Percent Predicted FEV1 at Indicated Time Points | Day 14: 4 hours, n=0,0,8 | 55.6 Percent predicted FEV1 | Standard Deviation 6.89 |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 2: Percent Predicted FEV1 at Indicated Time Points | Day 1: 0.25 hour, n=6,2,8 | 44.8 Percent predicted FEV1 | Standard Deviation 4.13 |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 2: Percent Predicted FEV1 at Indicated Time Points | Day 3: pre-dose, n=0,0,8 | 54.9 Percent predicted FEV1 | Standard Deviation 6.71 |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 2: Percent Predicted FEV1 at Indicated Time Points | Day 3: 4 hours, n=0,0,8 | 55.5 Percent predicted FEV1 | Standard Deviation 6.44 |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 2: Percent Predicted FEV1 at Indicated Time Points | Day 6: pre-dose, n=0,0,8 | 54.1 Percent predicted FEV1 | Standard Deviation 5.28 |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 2: Percent Predicted FEV1 at Indicated Time Points | Day 6: 4 hours, n=0,0,8 | 57.1 Percent predicted FEV1 | Standard Deviation 7.57 |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 2: Percent Predicted FEV1 at Indicated Time Points | Day 11: 4 hours, n=0,0,8 | 54.9 Percent predicted FEV1 | Standard Deviation 8.54 |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 2: Percent Predicted FEV1 at Indicated Time Points | Day 14: pre-dose, n=0,0,8 | 51.6 Percent predicted FEV1 | Standard Deviation 8.31 |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 2: Percent Predicted FEV1 at Indicated Time Points | Day 1: pre-dose, n=6,2,8 | 52.4 Percent predicted FEV1 | Standard Deviation 5.95 |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 2: Percent Predicted FEV1 at Indicated Time Points | Day 14: 0.25 hour, n=0,0,8 | 46.0 Percent predicted FEV1 | Standard Deviation 9.94 |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 2: Percent Predicted FEV1 at Indicated Time Points | Day 1: 4 hours, n=6,2,8 | 59.0 Percent predicted FEV1 | Standard Deviation 6.3 |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 2: Percent Predicted FEV1 at Indicated Time Points | Day 14: 0.5 hour, n=0,0,8 | 48.1 Percent predicted FEV1 | Standard Deviation 8.89 |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 2: Percent Predicted FEV1 at Indicated Time Points | Day 1: 0.5 hour, n=6,2,8 | 47.8 Percent predicted FEV1 | Standard Deviation 4.17 |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 2: Percent Predicted FEV1 at Indicated Time Points | Day 11: pre-dose, n=0,0,8 | 52.4 Percent predicted FEV1 | Standard Deviation 9.65 |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 2: Percent Predicted FEV1 at Indicated Time Points | Day 14: 1 hour, n=0,0,8 | 50.3 Percent predicted FEV1 | Standard Deviation 8.08 |
Primary
Part 2: Percent Predicted FVC at Indicated Time Points
FVC is a measure of lung function and the maximal amount of air that can be forcefully exhaled in one second. FVC was measured using standard spirometry. Percent predicted FVC was calculated as: Percent predicted FVC=(maximum FVC divided by predicted normal FVC)\*100.
Time frame: Day 1 and 14: pre-dose, 0.25, 0.5, 1 and 4 hours post-dose; Days 3, 6 and 11: pre-dose and 4 hours post-dose
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Cohort A- CCI15106 60 mg SD | Part 2: Percent Predicted FVC at Indicated Time Points | Day 1: pre-dose, n=6,2,8 | 74.5 Percent predicted FVC | Standard Deviation 19.07 |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 2: Percent Predicted FVC at Indicated Time Points | Day 1: 4 hours, n=6,2,8 | 82.0 Percent predicted FVC | Standard Deviation 15.59 |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 2: Percent Predicted FVC at Indicated Time Points | Day 1: 1 hour, n=6,2,8 | 76.7 Percent predicted FVC | Standard Deviation 20.49 |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 2: Percent Predicted FVC at Indicated Time Points | Day 1: 0.5 hour, n=6,2,8 | 74.7 Percent predicted FVC | Standard Deviation 18.48 |
| Part 1: Cohort A- CCI15106 60 mg SD | Part 2: Percent Predicted FVC at Indicated Time Points | Day 1: 0.25 hour, n=6,2,8 | 72.5 Percent predicted FVC | Standard Deviation 20.03 |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 2: Percent Predicted FVC at Indicated Time Points | Day 1: 0.25 hour, n=6,2,8 | 70.5 Percent predicted FVC | Standard Deviation 10.61 |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 2: Percent Predicted FVC at Indicated Time Points | Day 1: pre-dose, n=6,2,8 | 89.0 Percent predicted FVC | Standard Deviation 2.83 |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 2: Percent Predicted FVC at Indicated Time Points | Day 1: 0.5 hour, n=6,2,8 | 76.0 Percent predicted FVC | Standard Deviation 9.9 |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 2: Percent Predicted FVC at Indicated Time Points | Day 1: 1 hour, n=6,2,8 | 77.5 Percent predicted FVC | Standard Deviation 3.54 |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 2: Percent Predicted FVC at Indicated Time Points | Day 1: 4 hours, n=6,2,8 | 91.5 Percent predicted FVC | Standard Deviation 2.12 |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 2: Percent Predicted FVC at Indicated Time Points | Day 14: 0.5 hour, n=0,0,8 | 80.3 Percent predicted FVC | Standard Deviation 24.28 |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 2: Percent Predicted FVC at Indicated Time Points | Day 1: 0.5 hour, n=6,2,8 | 80.8 Percent predicted FVC | Standard Deviation 13.49 |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 2: Percent Predicted FVC at Indicated Time Points | Day 1: 4 hours, n=6,2,8 | 92.4 Percent predicted FVC | Standard Deviation 13.31 |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 2: Percent Predicted FVC at Indicated Time Points | Day 14: 1 hour, n=0,0,8 | 82.9 Percent predicted FVC | Standard Deviation 25.01 |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 2: Percent Predicted FVC at Indicated Time Points | Day 1: 1 hour, n=6,2,8 | 81.6 Percent predicted FVC | Standard Deviation 10.14 |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 2: Percent Predicted FVC at Indicated Time Points | Day 1: 0.25 hour, n=6,2,8 | 76.6 Percent predicted FVC | Standard Deviation 11.07 |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 2: Percent Predicted FVC at Indicated Time Points | Day 14: 4 hours, n=0,0,8 | 89.1 Percent predicted FVC | Standard Deviation 17.24 |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 2: Percent Predicted FVC at Indicated Time Points | Day 3: 4 hours, n=0,0,8 | 90.0 Percent predicted FVC | Standard Deviation 15.01 |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 2: Percent Predicted FVC at Indicated Time Points | Day 6: pre-dose, n=0,0,8 | 79.6 Percent predicted FVC | Standard Deviation 8.72 |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 2: Percent Predicted FVC at Indicated Time Points | Day 6: 4 hours, n=0,0,8 | 84.8 Percent predicted FVC | Standard Deviation 13.26 |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 2: Percent Predicted FVC at Indicated Time Points | Day 11: 4 hours, n=0,0,8 | 86.0 Percent predicted FVC | Standard Deviation 16.67 |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 2: Percent Predicted FVC at Indicated Time Points | Day 14: pre-dose, n=0,0,8 | 84.6 Percent predicted FVC | Standard Deviation 19.59 |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 2: Percent Predicted FVC at Indicated Time Points | Day 14: 0.25 hour, n=0,0,8 | 76.8 Percent predicted FVC | Standard Deviation 24.17 |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 2: Percent Predicted FVC at Indicated Time Points | Day 1: pre-dose, n=6,2,8 | 82.8 Percent predicted FVC | Standard Deviation 15.04 |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 2: Percent Predicted FVC at Indicated Time Points | Day 11: pre-dose, n=0,0,8 | 79.3 Percent predicted FVC | Standard Deviation 15.78 |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 2: Percent Predicted FVC at Indicated Time Points | Day 3: pre-dose, n=0,0,8 | 86.8 Percent predicted FVC | Standard Deviation 12.33 |
Secondary
Part 1: Concentration of CCI15106 in Lung Epithelial Lining Fluid (ELF) in Repeated Dose of Cohort B 60 mg
Bronchoalveolar lavage samples for ELF concentration analysis of CCI15106 were collected up to Day 13. Participants who received at least one dose of study treatment and who underwent bronchoalveolar lavage (BAL) sampling and had post-dose lung ELF CCI15106 and urea concentration result were included in BAL PK Population.
Time frame: Up to Day 13
Population: BAL PK Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Concentration of CCI15106 in Lung Epithelial Lining Fluid (ELF) in Repeated Dose of Cohort B 60 mg | 47306.383 Nanogram per milliliter | Standard Deviation 25231.0613 |
Secondary
Part 1: Number of Participants With Medical Device Incidents in CCI15106
A medical device incident is any malfunction or deterioration in the characteristics and/or performance of a device as well as any inadequacy in the labeling or the instructions for use which, directly or indirectly, might lead to or might have led to the death of a participant/user/other person or to a serious deterioration in his/her state of health.
Time frame: Up to Day 19
Population: Safety Population. The primary aim was to compare the safety profiles of the different active doses; hence, placebo arms have been combined as pre-specified in reporting and analysis plan.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1: Cohort A- CCI15106 60 mg SD | Part 1: Number of Participants With Medical Device Incidents in CCI15106 | 0 Participants |
| Part 1: Cohort A- CCI15106 120 mg SD | Part 1: Number of Participants With Medical Device Incidents in CCI15106 | 0 Participants |
| Part 1: Cohort A- CCI15106 30 mg BID | Part 1: Number of Participants With Medical Device Incidents in CCI15106 | 0 Participants |
| Part 1: Cohort A- Placebo | Part 1: Number of Participants With Medical Device Incidents in CCI15106 | 0 Participants |
| Part 1: Placebo | Part 1: Number of Participants With Medical Device Incidents in CCI15106 | 0 Participants |
Secondary
Part 2: Concentration of CCI15106 in ELF in Repeated Dose of Cohort B 60 mg
BAL samples for ELF concentration analysis of CCI15106 were collected up to Day 13.
Time frame: Up to Day 13
Population: BAL PK Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Cohort A- CCI15106 60 mg SD | Part 2: Concentration of CCI15106 in ELF in Repeated Dose of Cohort B 60 mg | 247290.327 Nanogram per milliliter | Standard Deviation 427471.7407 |