Trial Outcomes & Findings for Safety, Tolerability and Pharmacokinetics of Multiple Ascending Doses of AZD8871 in Healthy Subjects (NCT NCT02814656)
NCT ID: NCT02814656
Last Updated: 2019-02-15
Results Overview
Recording treatment emergent adverse events (TEAE). A TEAE was defined as an AE with onset (start date/time) after the first dose of investigational medicinal product. An AE is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition can be symptoms (e.g., nausea, chest pain), signs (e.g., tachycardia, enlarged liver) or the abnormal results of an investigation (e.g., laboratory findings, ECG).
COMPLETED
PHASE1
24 participants
Change from baseline up to Days 25-27
2019-02-15
Participant Flow
This study was conducted at a single centre in the UK. The first patient was screened in June 2016 and the last patient visit was in November 2016.
A single dose of 300 μg AZD8871 or placebo was administered to 8 healthy subjects following a 3-day washout period, dosing then continued for a further 12 days. Following the 1st cohort, 2 further cohorts of 8 subjects each were administered multiple ascending doses of AZD8871 in the same manner as Cohort 1.
Participant milestones
| Measure |
300 μg AZD8871
Participants received a single dose of AZD8871 300 μg on Day 1, followed by once daily dosing on Days 5 to 16.
|
600 μg AZD8871
Participants received a single dose of 600 μg AZD8871 on Day 1, followed by once daily dosing on Days 5 to 16.
|
900 μg AZD8871
Participants received a single dose of 900 μg AZD8871 on Day 1, followed by once daily dosing on Days 5 to 16.
|
Placebo
Participants received a single dose of Placebo on Day 1, followed by once daily dosing on Days 5 to 16.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety, Tolerability and Pharmacokinetics of Multiple Ascending Doses of AZD8871 in Healthy Subjects
Baseline characteristics by cohort
| Measure |
300 μg AZD8871
n=6 Participants
Participants received a single dose of AZD8871 300 μg on Day 1, followed by once daily dosing on Days 5 to 16.
|
600 μg AZD8871
n=6 Participants
Participants received a single dose of 600 μg AZD8871 on Day 1, followed by once daily dosing on Days 5 to 16.
|
900 μg AZD8871
n=6 Participants
Participants received a single dose of 900 μg AZD8871 on Day 1, followed by once daily dosing on Days 5 to 16.
|
Placebo
n=6 Participants
Participants received a single dose of Placebo on Day 1, followed by once daily dosing on Days 5 to 16.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
34.0 Years
STANDARD_DEVIATION 5.7 • n=99 Participants
|
44.2 Years
STANDARD_DEVIATION 7.9 • n=107 Participants
|
36.5 Years
STANDARD_DEVIATION 6.8 • n=206 Participants
|
41.5 Years
STANDARD_DEVIATION 7.6 • n=7 Participants
|
39.0 Years
STANDARD_DEVIATION 7.7 • n=31 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
24 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Change from baseline up to Days 25-27Population: Safety analysis population: defined as all participants who received at least one dose of the investigational product and for whom any post-dose safety data were available.
Recording treatment emergent adverse events (TEAE). A TEAE was defined as an AE with onset (start date/time) after the first dose of investigational medicinal product. An AE is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition can be symptoms (e.g., nausea, chest pain), signs (e.g., tachycardia, enlarged liver) or the abnormal results of an investigation (e.g., laboratory findings, ECG).
Outcome measures
| Measure |
300 μg AZD8871
n=6 Participants
Participants received a single dose of AZD8871 300 μg on Day 1, followed by once daily dosing on Days 5 to 16.
|
600 μg AZD8871
n=6 Participants
Participants received a single dose of 600 μg AZD8871 on Day 1, followed by once daily dosing on Days 5 to 16.
|
900 μg AZD8871
n=6 Participants
Participants received a single dose of 900 μg AZD8871 on Day 1, followed by once daily dosing on Days 5 to 16.
|
Placebo
n=6 Participants
Participants received a single dose of Placebo on Day 1, followed by once daily dosing on Days 5 to 16.
|
|---|---|---|---|---|
|
Number of Participants With ≥1 Treatment Emergent Adverse Event in Any Category.
|
3 Participants
|
1 Participants
|
5 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Change from baseline up to Days 25-27Population: Safety analysis population: defined as all participants who received at least one dose of the investigational product and for whom any post-dose safety data were available.
A full physical examination included the examination of the following: general appearance, eyes, ears, nose, throat, chest/respiratory, heart/cardiovascular, gastrointestinal/liver, musculoskeletal/extremities, dermatological/skin, thyroid/neck, lymph nodes, neurological/psychiatric. A brief physical examination included assessment of the following: skin, lungs, cardiovascular system and abdomen (liver and spleen). A complete physical examination was performed at the Screening Visit. Any abnormal finding assessed as the investigator as clinically relevant was reported as an adverse event.
Outcome measures
| Measure |
300 μg AZD8871
n=6 Participants
Participants received a single dose of AZD8871 300 μg on Day 1, followed by once daily dosing on Days 5 to 16.
|
600 μg AZD8871
n=6 Participants
Participants received a single dose of 600 μg AZD8871 on Day 1, followed by once daily dosing on Days 5 to 16.
|
900 μg AZD8871
n=6 Participants
Participants received a single dose of 900 μg AZD8871 on Day 1, followed by once daily dosing on Days 5 to 16.
|
Placebo
n=6 Participants
Participants received a single dose of Placebo on Day 1, followed by once daily dosing on Days 5 to 16.
|
|---|---|---|---|---|
|
Number of Participants With Clinically Relevant Abnormalities in Recording of Physical Examination.
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Change from baseline up to Days 25-27Population: Safety analysis population: defined as all participants who received at least one dose of the investigational product and for whom any post-dose safety data were available.
Systolic and diastolic BP (SBP/DBP) (in mmHg) measured after at least 10 minutes (could be reduced to 5 minutes at collection time points within the 1st hour after dosing) resting, and also before taking any blood sample and conducting any spirometry. Measurements were carried out with subject in the supine position and preferably always on the same arm. Subject's oral body temperature was measured at each vital signs collection.
Outcome measures
| Measure |
300 μg AZD8871
n=6 Participants
Participants received a single dose of AZD8871 300 μg on Day 1, followed by once daily dosing on Days 5 to 16.
|
600 μg AZD8871
n=6 Participants
Participants received a single dose of 600 μg AZD8871 on Day 1, followed by once daily dosing on Days 5 to 16.
|
900 μg AZD8871
n=6 Participants
Participants received a single dose of 900 μg AZD8871 on Day 1, followed by once daily dosing on Days 5 to 16.
|
Placebo
n=6 Participants
Participants received a single dose of Placebo on Day 1, followed by once daily dosing on Days 5 to 16.
|
|---|---|---|---|---|
|
Number of Participants With Clinically Relevant Abnormalities in Vital Signs (Pulse, Blood Pressure and Body Temperature).
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Changes from baseline up to Days 25-27Population: Safety analysis population: defined as all participants who received at least one dose of the investigational product and for whom any post-dose safety data were available.
Haematocrit, haemoglobin, erythrocytes (red blood cells), mean corpuscular volume, mean corpuscular haemoglobin, mean corpuscular haemoglobin concentration, leucocytes (white blood cells), differential blood count (neutrophils, lymphocytes, monocytes, eosinophils and basophils), and thrombocytes (platelets).
Outcome measures
| Measure |
300 μg AZD8871
n=6 Participants
Participants received a single dose of AZD8871 300 μg on Day 1, followed by once daily dosing on Days 5 to 16.
|
600 μg AZD8871
n=6 Participants
Participants received a single dose of 600 μg AZD8871 on Day 1, followed by once daily dosing on Days 5 to 16.
|
900 μg AZD8871
n=6 Participants
Participants received a single dose of 900 μg AZD8871 on Day 1, followed by once daily dosing on Days 5 to 16.
|
Placebo
n=6 Participants
Participants received a single dose of Placebo on Day 1, followed by once daily dosing on Days 5 to 16.
|
|---|---|---|---|---|
|
Number of Participants With Clinically Relevant New Findings or Worsening of Pre-existing Findings as Assessed by Haematology.
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Changes from baseline up to Days 25-27Population: Safety analysis population: defined as all participants who received at least one dose of the investigational product and for whom any post-dose safety data were available.
A 12-lead ECG was obtained after the subject rested in the supine position for at least 10 minutes (could be reduced to 5 minutes at collection time points within the first hour after dosing) (using the sites own ECG machines when not performing dECGs and using the same machine as the dECGs when time points coincided).
Outcome measures
| Measure |
300 μg AZD8871
n=6 Participants
Participants received a single dose of AZD8871 300 μg on Day 1, followed by once daily dosing on Days 5 to 16.
|
600 μg AZD8871
n=6 Participants
Participants received a single dose of 600 μg AZD8871 on Day 1, followed by once daily dosing on Days 5 to 16.
|
900 μg AZD8871
n=6 Participants
Participants received a single dose of 900 μg AZD8871 on Day 1, followed by once daily dosing on Days 5 to 16.
|
Placebo
n=6 Participants
Participants received a single dose of Placebo on Day 1, followed by once daily dosing on Days 5 to 16.
|
|---|---|---|---|---|
|
Number of Participants With Clinically Relevant Abnormalities in 12-lead Safety ECG.
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Changes from baseline up to Day 20 (discharge from study unit)Population: Safety analysis population: defined as all participants who received at least one dose of the investigational product and for whom any post-dose safety data were available.
Recording of telemetry findings. A 2-lead real-time telemetry ECG was performed for at least 4 hours on Day -1 and then on Days 1, 10 and 16 from 30 minutes pre-dose until 24 hours post-dose. The telemetry monitoring system was reviewed by the Investigator or research nurse and paper printouts of any clinically important events were stored as source data.
Outcome measures
| Measure |
300 μg AZD8871
n=6 Participants
Participants received a single dose of AZD8871 300 μg on Day 1, followed by once daily dosing on Days 5 to 16.
|
600 μg AZD8871
n=6 Participants
Participants received a single dose of 600 μg AZD8871 on Day 1, followed by once daily dosing on Days 5 to 16.
|
900 μg AZD8871
n=6 Participants
Participants received a single dose of 900 μg AZD8871 on Day 1, followed by once daily dosing on Days 5 to 16.
|
Placebo
n=6 Participants
Participants received a single dose of Placebo on Day 1, followed by once daily dosing on Days 5 to 16.
|
|---|---|---|---|---|
|
Number of Participants With Clinically Relevant Abnormalities in Telemetry ECG.
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Changes from baseline up to Days 25-27Population: Safety analysis population: defined as all participants who received at least one dose of the investigational product and for whom any post-dose safety data were available.
Electrolytes: Sodium, potassium, calcium, chloride and inorganic phosphorus Enzymes: AST, ALT, ALP, GGT, LDH, creatine-kinase Substrates: Glucose (fasting), total cholesterol, triglycerides, creatinine, TBL, total protein, albumin, uric acid, urea and BUN Endocrinology: T4, TSH Viral Serology: HIV I and II antibodies, Hepatitis C antibodies, Hepatitis B surface antigen, Hepatitis B core (HBc) immunoglobulin antibodies Coagulation parameters: INR, PT, aPTT
Outcome measures
| Measure |
300 μg AZD8871
n=6 Participants
Participants received a single dose of AZD8871 300 μg on Day 1, followed by once daily dosing on Days 5 to 16.
|
600 μg AZD8871
n=6 Participants
Participants received a single dose of 600 μg AZD8871 on Day 1, followed by once daily dosing on Days 5 to 16.
|
900 μg AZD8871
n=6 Participants
Participants received a single dose of 900 μg AZD8871 on Day 1, followed by once daily dosing on Days 5 to 16.
|
Placebo
n=6 Participants
Participants received a single dose of Placebo on Day 1, followed by once daily dosing on Days 5 to 16.
|
|---|---|---|---|---|
|
Number of Participants With Clinically Relevant New Findings or Worsening of a Pre-existing Findings as Assessed by Clinical Chemistry.
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Changes from baseline up to Days 25-27Population: Safety analysis population: defined as all participants who received at least one dose of the investigational product and for whom any post-dose safety data were available.
Dipstick analysis was performed at the centre and included: pH, blood, leucocytes, protein, glucose, bilirubin, urobilinogen, ketones and nitrites. If clinically relevant abnormalities were detected (positive result in dipstick), microscopy (RBC, WBC and casts \[Hyaline, Granular and Cellular\]) were performed.
Outcome measures
| Measure |
300 μg AZD8871
n=6 Participants
Participants received a single dose of AZD8871 300 μg on Day 1, followed by once daily dosing on Days 5 to 16.
|
600 μg AZD8871
n=6 Participants
Participants received a single dose of 600 μg AZD8871 on Day 1, followed by once daily dosing on Days 5 to 16.
|
900 μg AZD8871
n=6 Participants
Participants received a single dose of 900 μg AZD8871 on Day 1, followed by once daily dosing on Days 5 to 16.
|
Placebo
n=6 Participants
Participants received a single dose of Placebo on Day 1, followed by once daily dosing on Days 5 to 16.
|
|---|---|---|---|---|
|
Number of Participants With Clinically Relevant New Findings or Worsening of Pre-existing Findings as Assessed by Urinalysis Report.
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Changes from baseline up to Day 20Population: Safety analysis population: defined as all participants who received at least one dose of the investigational product and for whom any post-dose safety data were available.
The AZ ECG Centre performed the digital ECG (dECG) analysis in this study, using the EClysis© system, version 3.3, or higher. At protocol-indicated time points, 12-lead continuous dECG was recorded over at least 5 minutes with the Schiller Cardiovit CS-200 recorder (Schiller AG, Baar, Switzerland) and transmitted to the AZ central dECG repository, according to AZ ECG Centre´s standard procedures for settings, recording and transmission of dECGs
Outcome measures
| Measure |
300 μg AZD8871
n=6 Participants
Participants received a single dose of AZD8871 300 μg on Day 1, followed by once daily dosing on Days 5 to 16.
|
600 μg AZD8871
n=6 Participants
Participants received a single dose of 600 μg AZD8871 on Day 1, followed by once daily dosing on Days 5 to 16.
|
900 μg AZD8871
n=6 Participants
Participants received a single dose of 900 μg AZD8871 on Day 1, followed by once daily dosing on Days 5 to 16.
|
Placebo
n=6 Participants
Participants received a single dose of Placebo on Day 1, followed by once daily dosing on Days 5 to 16.
|
|---|---|---|---|---|
|
Number of Participants With Clinically Relevant Abnormalities in 12-lead dECG (Including High Precision QTc Analysis) Findings.
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1, pre-dose and at 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dosePopulation: Pharmacokinetic analysis population: defined as all participants in the safety analysis population who received at least 1 dose of AZD8871 and had at least 1 of the parameters Cmax, AUC or AUClast evaluable for AZD8871 and were assumed not to be affected by factors such as protocol deviations.
Observed maximum concentration, taken directly from the individual concentration-time curve (Cmax) of AZD8871 and its metabolites (LAS191861 and LAS34850).
Outcome measures
| Measure |
300 μg AZD8871
n=6 Participants
Participants received a single dose of AZD8871 300 μg on Day 1, followed by once daily dosing on Days 5 to 16.
|
600 μg AZD8871
n=6 Participants
Participants received a single dose of 600 μg AZD8871 on Day 1, followed by once daily dosing on Days 5 to 16.
|
900 μg AZD8871
n=6 Participants
Participants received a single dose of 900 μg AZD8871 on Day 1, followed by once daily dosing on Days 5 to 16.
|
Placebo
Participants received a single dose of Placebo on Day 1, followed by once daily dosing on Days 5 to 16.
|
|---|---|---|---|---|
|
Observed Maximum Concentration (Cmax) of AZD8871 and Its Metabolites (Single Dose).
LAS34850
|
708.5 pg/mL
Geometric Coefficient of Variation 31.44
|
1376 pg/mL
Geometric Coefficient of Variation 19.63
|
1839 pg/mL
Geometric Coefficient of Variation 33.17
|
—
|
|
Observed Maximum Concentration (Cmax) of AZD8871 and Its Metabolites (Single Dose).
AZD8871
|
397.0 pg/mL
Geometric Coefficient of Variation 28.66
|
991.1 pg/mL
Geometric Coefficient of Variation 63.45
|
1568 pg/mL
Geometric Coefficient of Variation 20.41
|
—
|
|
Observed Maximum Concentration (Cmax) of AZD8871 and Its Metabolites (Single Dose).
LAS191861
|
20.17 pg/mL
Geometric Coefficient of Variation 28.38
|
60.08 pg/mL
Geometric Coefficient of Variation 50.10
|
96.31 pg/mL
Geometric Coefficient of Variation 24.66
|
—
|
SECONDARY outcome
Timeframe: Day 16, pre-dose and at 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dosePopulation: Pharmacokinetic analysis population: defined as all participants in the safety analysis population who received at least 1 dose of AZD8871 and had at least 1 of the parameters Cmax, AUC or AUClast evaluable for AZD8871 and were assumed not to be affected by factors such as protocol deviations.
Observed maximum concentration, taken directly from the individual concentration-time curve (Cmax) of AZD8871 and its metabolites (LAS191861 and LAS34850).
Outcome measures
| Measure |
300 μg AZD8871
n=6 Participants
Participants received a single dose of AZD8871 300 μg on Day 1, followed by once daily dosing on Days 5 to 16.
|
600 μg AZD8871
n=6 Participants
Participants received a single dose of 600 μg AZD8871 on Day 1, followed by once daily dosing on Days 5 to 16.
|
900 μg AZD8871
n=6 Participants
Participants received a single dose of 900 μg AZD8871 on Day 1, followed by once daily dosing on Days 5 to 16.
|
Placebo
Participants received a single dose of Placebo on Day 1, followed by once daily dosing on Days 5 to 16.
|
|---|---|---|---|---|
|
Observed Maximum Concentration (Cmax) of AZD8871 and Its Metabolites (Day 16).
AZD8871
|
406.5 pg/mL
Geometric Coefficient of Variation 34.44
|
1018 pg/mL
Geometric Coefficient of Variation 53.64
|
1830 pg/mL
Geometric Coefficient of Variation 28.47
|
—
|
|
Observed Maximum Concentration (Cmax) of AZD8871 and Its Metabolites (Day 16).
LAS191861
|
53.80 pg/mL
Geometric Coefficient of Variation 35.18
|
119.3 pg/mL
Geometric Coefficient of Variation 39.47
|
204.5 pg/mL
Geometric Coefficient of Variation 25.14
|
—
|
|
Observed Maximum Concentration (Cmax) of AZD8871 and Its Metabolites (Day 16).
LAS34850
|
905.4 pg/mL
Geometric Coefficient of Variation 29.90
|
2067 pg/mL
Geometric Coefficient of Variation 21.49
|
2340 pg/mL
Geometric Coefficient of Variation 38.41
|
—
|
SECONDARY outcome
Timeframe: Day 1, pre-dose and at 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dosePopulation: Pharmacokinetic analysis population: defined as all participants in the safety analysis population who received at least 1 dose of AZD8871 and had at least 1 of the parameters Cmax, AUC or AUClast evaluable for AZD8871 and were assumed not to be affected by factors such as protocol deviations.
Time to reach maximum concentration, taken directly from the individual concentration-time curve (tmax) of AZD8871 and its metabolites (LAS191861 and LAS34850).
Outcome measures
| Measure |
300 μg AZD8871
n=6 Participants
Participants received a single dose of AZD8871 300 μg on Day 1, followed by once daily dosing on Days 5 to 16.
|
600 μg AZD8871
n=6 Participants
Participants received a single dose of 600 μg AZD8871 on Day 1, followed by once daily dosing on Days 5 to 16.
|
900 μg AZD8871
n=6 Participants
Participants received a single dose of 900 μg AZD8871 on Day 1, followed by once daily dosing on Days 5 to 16.
|
Placebo
Participants received a single dose of Placebo on Day 1, followed by once daily dosing on Days 5 to 16.
|
|---|---|---|---|---|
|
Time to Reach Maximum Concentration (Tmax) of AZD8871 and Its Metabolites (Single Dose).
AZD8871
|
1.50 h
Interval 1.0 to 1.52
|
1.52 h
Interval 1.5 to 1.55
|
1.51 h
Interval 1.48 to 1.52
|
—
|
|
Time to Reach Maximum Concentration (Tmax) of AZD8871 and Its Metabolites (Single Dose).
LAS191861
|
1.51 h
Interval 1.5 to 2.0
|
1.55 h
Interval 1.5 to 2.02
|
2.00 h
Interval 1.48 to 2.02
|
—
|
|
Time to Reach Maximum Concentration (Tmax) of AZD8871 and Its Metabolites (Single Dose).
LAS34850
|
4.00 h
Interval 3.0 to 6.0
|
3.00 h
Interval 3.0 to 4.02
|
4.00 h
Interval 2.0 to 5.98
|
—
|
SECONDARY outcome
Timeframe: Day 16, pre-dose and at 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dosePopulation: Pharmacokinetic analysis population: defined as all participants in the safety analysis population who received at least 1 dose of AZD8871 and had at least 1 of the parameters Cmax, AUC or AUClast evaluable for AZD8871 and were assumed not to be affected by factors such as protocol deviations.
Time to reach maximum concentration, taken directly from the individual concentration-time curve (tmax) of AZD8871 and its metabolites (LAS191861 and LAS34850).
Outcome measures
| Measure |
300 μg AZD8871
n=6 Participants
Participants received a single dose of AZD8871 300 μg on Day 1, followed by once daily dosing on Days 5 to 16.
|
600 μg AZD8871
n=6 Participants
Participants received a single dose of 600 μg AZD8871 on Day 1, followed by once daily dosing on Days 5 to 16.
|
900 μg AZD8871
n=6 Participants
Participants received a single dose of 900 μg AZD8871 on Day 1, followed by once daily dosing on Days 5 to 16.
|
Placebo
Participants received a single dose of Placebo on Day 1, followed by once daily dosing on Days 5 to 16.
|
|---|---|---|---|---|
|
Time to Reach Maximum Concentration (Tmax) of AZD8871 and Its Metabolites (Day 16).
AZD8871
|
1.50 h
Interval 1.5 to 1.53
|
1.50 h
Interval 1.48 to 1.5
|
1.50 h
Interval 1.5 to 1.5
|
—
|
|
Time to Reach Maximum Concentration (Tmax) of AZD8871 and Its Metabolites (Day 16).
LAS191861
|
1.50 h
Interval 1.0 to 2.0
|
1.50 h
Interval 1.48 to 2.0
|
1.50 h
Interval 1.5 to 1.5
|
—
|
|
Time to Reach Maximum Concentration (Tmax) of AZD8871 and Its Metabolites (Day 16).
LAS34850
|
3.51 h
Interval 1.5 to 4.03
|
4.01 h
Interval 2.98 to 6.0
|
4.01 h
Interval 2.0 to 6.0
|
—
|
SECONDARY outcome
Timeframe: Day 1, pre-dose and at 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dosePopulation: Pharmacokinetic analysis population: defined as all participants in the safety analysis population who received at least 1 dose of AZD8871 and had at least 1 of the parameters Cmax, AUC or AUClast evaluable for AZD8871 and were assumed not to be affected by factors such as protocol deviations.
Terminal elimination half-life (t½λz) of AZD8871 and its metabolites (LAS191861 and LAS34850), estimated as (ln2)/ λz.
Outcome measures
| Measure |
300 μg AZD8871
n=6 Participants
Participants received a single dose of AZD8871 300 μg on Day 1, followed by once daily dosing on Days 5 to 16.
|
600 μg AZD8871
n=6 Participants
Participants received a single dose of 600 μg AZD8871 on Day 1, followed by once daily dosing on Days 5 to 16.
|
900 μg AZD8871
n=6 Participants
Participants received a single dose of 900 μg AZD8871 on Day 1, followed by once daily dosing on Days 5 to 16.
|
Placebo
Participants received a single dose of Placebo on Day 1, followed by once daily dosing on Days 5 to 16.
|
|---|---|---|---|---|
|
Terminal Half-life (t½λz) of AZD8871 and Its Metabolites (Single Dose).
AZD8871
|
50.44 h
Standard Deviation 6.796
|
42.89 h
Standard Deviation 11.99
|
49.24 h
Standard Deviation 9.055
|
—
|
|
Terminal Half-life (t½λz) of AZD8871 and Its Metabolites (Single Dose).
LAS191861
|
46.51 h
Standard Deviation 22.36
|
67.90 h
Standard Deviation 57.19
|
69.43 h
Standard Deviation 7.989
|
—
|
|
Terminal Half-life (t½λz) of AZD8871 and Its Metabolites (Single Dose).
LAS34850
|
12.15 h
Standard Deviation 6.649
|
36.37 h
Standard Deviation 21.94
|
37.01 h
Standard Deviation 16.91
|
—
|
SECONDARY outcome
Timeframe: Day 16, pre-dose and at 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dosePopulation: Pharmacokinetic analysis population: defined as all participants in the safety analysis population who received at least 1 dose of AZD8871 and had at least 1 of the parameters Cmax, AUC or AUClast evaluable for AZD8871 and were assumed not to be affected by factors such as protocol deviations.
Terminal elimination half-life (t½λz) of AZD8871 and its metabolites (LAS191861 and LAS34850), estimated as (ln2)/ λz.
Outcome measures
| Measure |
300 μg AZD8871
n=6 Participants
Participants received a single dose of AZD8871 300 μg on Day 1, followed by once daily dosing on Days 5 to 16.
|
600 μg AZD8871
n=6 Participants
Participants received a single dose of 600 μg AZD8871 on Day 1, followed by once daily dosing on Days 5 to 16.
|
900 μg AZD8871
n=6 Participants
Participants received a single dose of 900 μg AZD8871 on Day 1, followed by once daily dosing on Days 5 to 16.
|
Placebo
Participants received a single dose of Placebo on Day 1, followed by once daily dosing on Days 5 to 16.
|
|---|---|---|---|---|
|
Terminal Half-life (t½λz) of AZD8871 and Its Metabolites (Day 16).
AZD8871
|
78.51 h
Standard Deviation 11.01
|
62.39 h
Standard Deviation 16.69
|
70.19 h
Standard Deviation 4.144
|
—
|
|
Terminal Half-life (t½λz) of AZD8871 and Its Metabolites (Day 16).
LAS191861
|
0.00 h
Standard Deviation 0.00
|
98.78 h
Standard Deviation 30.75
|
—
|
—
|
|
Terminal Half-life (t½λz) of AZD8871 and Its Metabolites (Day 16).
LAS34850
|
51.20 h
Standard Deviation 9.373
|
67.07 h
Standard Deviation 27.46
|
61.46 h
Standard Deviation 8.128
|
—
|
SECONDARY outcome
Timeframe: Day 1, pre-dose and at 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dosePopulation: Pharmacokinetic analysis population: defined as all participants in the safety analysis population who received at least 1 dose of AZD8871 and had at least 1 of the parameters Cmax, AUC or AUClast evaluable for AZD8871 and were assumed not to be affected by factors such as protocol deviations.
Area under the plasma concentration-curve from time zero to 24 hours post-dose (AUC\[0-24\]) of AZD8871 and its metabolites (LAS191861 and LAS34850).
Outcome measures
| Measure |
300 μg AZD8871
n=6 Participants
Participants received a single dose of AZD8871 300 μg on Day 1, followed by once daily dosing on Days 5 to 16.
|
600 μg AZD8871
n=6 Participants
Participants received a single dose of 600 μg AZD8871 on Day 1, followed by once daily dosing on Days 5 to 16.
|
900 μg AZD8871
n=6 Participants
Participants received a single dose of 900 μg AZD8871 on Day 1, followed by once daily dosing on Days 5 to 16.
|
Placebo
Participants received a single dose of Placebo on Day 1, followed by once daily dosing on Days 5 to 16.
|
|---|---|---|---|---|
|
AUC(0-24) of AZD8871 and Its Metabolites (Single Dose).
AZD8871
|
1272 pg.h/mL
Geometric Coefficient of Variation 18.69
|
3805 pg.h/mL
Geometric Coefficient of Variation 58.72
|
4862 pg.h/mL
Geometric Coefficient of Variation 15.58
|
—
|
|
AUC(0-24) of AZD8871 and Its Metabolites (Single Dose).
LAS191861
|
152.5 pg.h/mL
Geometric Coefficient of Variation 20.04
|
493.7 pg.h/mL
Geometric Coefficient of Variation 42.75
|
770.3 pg.h/mL
Geometric Coefficient of Variation 33.90
|
—
|
|
AUC(0-24) of AZD8871 and Its Metabolites (Single Dose).
LAS34850
|
5761 pg.h/mL
Geometric Coefficient of Variation 34.07
|
12540 pg.h/mL
Geometric Coefficient of Variation 23.58
|
18720 pg.h/mL
Geometric Coefficient of Variation 32.55
|
—
|
SECONDARY outcome
Timeframe: Day 16, pre-dose and at 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dosePopulation: Pharmacokinetic analysis population: defined as all participants in the safety analysis population who received at least 1 dose of AZD8871 and had at least 1 of the parameters Cmax, AUC or AUClast evaluable for AZD8871 and were assumed not to be affected by factors such as protocol deviations.
Area under the plasma concentration-curve from time zero to 24 hours post-dose (AUC\[0-24\]) of AZD8871 and its metabolites (LAS191861 and LAS34850).
Outcome measures
| Measure |
300 μg AZD8871
n=6 Participants
Participants received a single dose of AZD8871 300 μg on Day 1, followed by once daily dosing on Days 5 to 16.
|
600 μg AZD8871
n=6 Participants
Participants received a single dose of 600 μg AZD8871 on Day 1, followed by once daily dosing on Days 5 to 16.
|
900 μg AZD8871
n=6 Participants
Participants received a single dose of 900 μg AZD8871 on Day 1, followed by once daily dosing on Days 5 to 16.
|
Placebo
Participants received a single dose of Placebo on Day 1, followed by once daily dosing on Days 5 to 16.
|
|---|---|---|---|---|
|
AUC(0-24) of AZD8871 and Its Metabolites (Day 16).
AZD8871
|
2103 pg.h/mL
Geometric Coefficient of Variation 25.20
|
5508 pg.h/mL
Geometric Coefficient of Variation 47.25
|
7077 pg.h/mL
Geometric Coefficient of Variation 19.87
|
—
|
|
AUC(0-24) of AZD8871 and Its Metabolites (Day 16).
LAS191861
|
528.9 pg.h/mL
Geometric Coefficient of Variation 15.70
|
1248 pg.h/mL
Geometric Coefficient of Variation 34.57
|
1911 pg.h/mL
Geometric Coefficient of Variation 34.68
|
—
|
|
AUC(0-24) of AZD8871 and Its Metabolites (Day 16).
LAS34850
|
8848 pg.h/mL
Geometric Coefficient of Variation 23.82
|
22580 pg.h/mL
Geometric Coefficient of Variation 29.69
|
27300 pg.h/mL
Geometric Coefficient of Variation 28.27
|
—
|
SECONDARY outcome
Timeframe: Day 1, pre-dose and at 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dosePopulation: Pharmacokinetic analysis population: defined as all participants in the safety analysis population who received at least 1 dose of AZD8871 and had at least 1 of the parameters Cmax, AUC or AUClast evaluable for AZD8871 and were assumed not to be affected by factors such as protocol deviations.
Area under the concentration-time curve of AZD8871 and its metabolites (LAS191861 and LAS34850) from time zero extrapolated to infinity. AUC is estimated by AUC0-last + Clast/λz where Clast is the last observed quantifiable concentration.
Outcome measures
| Measure |
300 μg AZD8871
n=6 Participants
Participants received a single dose of AZD8871 300 μg on Day 1, followed by once daily dosing on Days 5 to 16.
|
600 μg AZD8871
n=6 Participants
Participants received a single dose of 600 μg AZD8871 on Day 1, followed by once daily dosing on Days 5 to 16.
|
900 μg AZD8871
n=6 Participants
Participants received a single dose of 900 μg AZD8871 on Day 1, followed by once daily dosing on Days 5 to 16.
|
Placebo
Participants received a single dose of Placebo on Day 1, followed by once daily dosing on Days 5 to 16.
|
|---|---|---|---|---|
|
AUC of AZD8871 and Its Metabolites (Single Dose).
LAS34850
|
6553 pg.h/mL
Geometric Coefficient of Variation 38.03
|
16830 pg.h/mL
Geometric Coefficient of Variation 36.65
|
24340 pg.h/mL
Geometric Coefficient of Variation 38.79
|
—
|
|
AUC of AZD8871 and Its Metabolites (Single Dose).
AZD8871
|
2218 pg.h/mL
Geometric Coefficient of Variation 21.18
|
5574 pg.h/mL
Geometric Coefficient of Variation 79.73
|
7496 pg.h/mL
Geometric Coefficient of Variation 14.24
|
—
|
|
AUC of AZD8871 and Its Metabolites (Single Dose).
LAS191861
|
—
|
0.00 pg.h/mL
Geometric Coefficient of Variation 0.00
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1, pre-dose and at 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dosePopulation: Pharmacokinetic analysis population: defined as all participants in the safety analysis population who received at least 1 dose of AZD8871 and had at least 1 of the parameters Cmax, AUC or AUClast evaluable for AZD8871 and were assumed not to be affected by factors such as protocol deviations.
Apparent clearance for parent drug (CL/F) estimated as dose divided by AUC of AZD8871.
Outcome measures
| Measure |
300 μg AZD8871
n=6 Participants
Participants received a single dose of AZD8871 300 μg on Day 1, followed by once daily dosing on Days 5 to 16.
|
600 μg AZD8871
n=6 Participants
Participants received a single dose of 600 μg AZD8871 on Day 1, followed by once daily dosing on Days 5 to 16.
|
900 μg AZD8871
n=6 Participants
Participants received a single dose of 900 μg AZD8871 on Day 1, followed by once daily dosing on Days 5 to 16.
|
Placebo
Participants received a single dose of Placebo on Day 1, followed by once daily dosing on Days 5 to 16.
|
|---|---|---|---|---|
|
Apparent Clearance for Parent Drug (CL/F) (Single Dose).
|
137.8 L/h
Standard Deviation 28.30
|
133.7 L/h
Standard Deviation 115.1
|
121.1 L/h
Standard Deviation 17.47
|
—
|
SECONDARY outcome
Timeframe: Day 16, pre-dose and at 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dosePopulation: Pharmacokinetic analysis population: defined as all participants in the safety analysis population who received at least 1 dose of AZD8871 and had at least 1 of the parameters Cmax, AUC or AUClast evaluable for AZD8871 and were assumed not to be affected by factors such as protocol deviations.
Apparent clearance for parent drug (CL/F) estimated as dose divided by AUC(0-24) of AZD8871.
Outcome measures
| Measure |
300 μg AZD8871
n=6 Participants
Participants received a single dose of AZD8871 300 μg on Day 1, followed by once daily dosing on Days 5 to 16.
|
600 μg AZD8871
n=6 Participants
Participants received a single dose of 600 μg AZD8871 on Day 1, followed by once daily dosing on Days 5 to 16.
|
900 μg AZD8871
n=6 Participants
Participants received a single dose of 900 μg AZD8871 on Day 1, followed by once daily dosing on Days 5 to 16.
|
Placebo
Participants received a single dose of Placebo on Day 1, followed by once daily dosing on Days 5 to 16.
|
|---|---|---|---|---|
|
Apparent Clearance for Parent Drug (CL/F) (Day 16).
|
146.2 L/h
Standard Deviation 33.62
|
120.2 L/h
Standard Deviation 67.93
|
129.3 L/h
Standard Deviation 26.27
|
—
|
SECONDARY outcome
Timeframe: Day 1, pre-dose and at 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dosePopulation: Pharmacokinetic analysis population: defined as all participants in the safety analysis population who received at least 1 dose of AZD8871 and had at least 1 of the parameters Cmax, AUC or AUClast evaluable for AZD8871 and were assumed not to be affected by factors such as protocol deviations.
Apparent volume of distribution for parent drug at terminal phase (Vz/F) (extravascular administration), estimated by dividing the apparent clearance (CL/F) by λz of AZD8871.
Outcome measures
| Measure |
300 μg AZD8871
n=6 Participants
Participants received a single dose of AZD8871 300 μg on Day 1, followed by once daily dosing on Days 5 to 16.
|
600 μg AZD8871
n=6 Participants
Participants received a single dose of 600 μg AZD8871 on Day 1, followed by once daily dosing on Days 5 to 16.
|
900 μg AZD8871
n=6 Participants
Participants received a single dose of 900 μg AZD8871 on Day 1, followed by once daily dosing on Days 5 to 16.
|
Placebo
Participants received a single dose of Placebo on Day 1, followed by once daily dosing on Days 5 to 16.
|
|---|---|---|---|---|
|
Apparent Volume of Distribution for Parent Drug at Terminal Phase (Vz/F) (Single Dose).
|
9873 L
Standard Deviation 1677
|
6737 L
Standard Deviation 4406
|
8724 L
Standard Deviation 2770
|
—
|
SECONDARY outcome
Timeframe: Days 1 and 16, pre-dose and at 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dosePopulation: Pharmacokinetic analysis population: defined as all participants in the safety analysis population who received at least 1 dose of AZD8871 and had at least 1 of the parameters Cmax, AUC or AUClast evaluable for AZD8871 and were assumed not to be affected by factors such as protocol deviations.
Accumulation ratio for Cmax estimated as (Cmax pg/mL on Day 16/ Cmax pg/mL on Day 1) of AZD8871 and its metabolites (LAS191861 and LAS34850).
Outcome measures
| Measure |
300 μg AZD8871
n=6 Participants
Participants received a single dose of AZD8871 300 μg on Day 1, followed by once daily dosing on Days 5 to 16.
|
600 μg AZD8871
n=6 Participants
Participants received a single dose of 600 μg AZD8871 on Day 1, followed by once daily dosing on Days 5 to 16.
|
900 μg AZD8871
n=6 Participants
Participants received a single dose of 900 μg AZD8871 on Day 1, followed by once daily dosing on Days 5 to 16.
|
Placebo
Participants received a single dose of Placebo on Day 1, followed by once daily dosing on Days 5 to 16.
|
|---|---|---|---|---|
|
Accumulation Ratio for Cmax (Rac[Cmax]) for AZD8871 and Its Metabolites (Day 16).
AZD8871
|
1.032 Ratio
Interval 0.881 to 1.23
|
1.054 Ratio
Interval 0.979 to 1.12
|
1.181 Ratio
Interval 0.843 to 1.4
|
—
|
|
Accumulation Ratio for Cmax (Rac[Cmax]) for AZD8871 and Its Metabolites (Day 16).
LAS191861
|
2.794 Ratio
Interval 1.79 to 4.77
|
1.897 Ratio
Interval 1.59 to 2.04
|
2.153 Ratio
Interval 1.67 to 2.7
|
—
|
|
Accumulation Ratio for Cmax (Rac[Cmax]) for AZD8871 and Its Metabolites (Day 16).
LAS34850
|
1.304 Ratio
Interval 1.0 to 1.67
|
1.431 Ratio
Interval 1.3 to 1.51
|
1.275 Ratio
Interval 1.19 to 1.44
|
—
|
SECONDARY outcome
Timeframe: Days 1 and 16, pre-dose and at 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dosePopulation: Pharmacokinetic analysis population: defined as all participants in the safety analysis population who received at least 1 dose of AZD8871 and had at least 1 of the parameters Cmax, AUC or AUClast evaluable for AZD8871 and were assumed not to be affected by factors such as protocol deviations.
Accumulation ratio for AUC0-24 (Rac\[AUC0-24\]) for AZD8871 and its metabolites (LAS191861 and LAS34850) estimated as (AUC(0-24) pg.h/mL on Day 16/ AUC(0-24) pg.h/mL on Day 1).
Outcome measures
| Measure |
300 μg AZD8871
n=6 Participants
Participants received a single dose of AZD8871 300 μg on Day 1, followed by once daily dosing on Days 5 to 16.
|
600 μg AZD8871
n=6 Participants
Participants received a single dose of 600 μg AZD8871 on Day 1, followed by once daily dosing on Days 5 to 16.
|
900 μg AZD8871
n=6 Participants
Participants received a single dose of 900 μg AZD8871 on Day 1, followed by once daily dosing on Days 5 to 16.
|
Placebo
Participants received a single dose of Placebo on Day 1, followed by once daily dosing on Days 5 to 16.
|
|---|---|---|---|---|
|
Accumulation Ratio for AUC0-24 (Rac[AUC0-24]) for AZD8871 and Its Metabolites (Day 16).
AZD8871
|
1.675 Ratio
Interval 1.33 to 2.14
|
1.451 Ratio
Interval 1.25 to 1.6
|
1.463 Ratio
Interval 1.2 to 1.58
|
—
|
|
Accumulation Ratio for AUC0-24 (Rac[AUC0-24]) for AZD8871 and Its Metabolites (Day 16).
LAS191861
|
3.510 Ratio
Interval 2.55 to 4.28
|
2.398 Ratio
Interval 1.83 to 3.08
|
2.494 Ratio
Interval 2.2 to 3.0
|
—
|
|
Accumulation Ratio for AUC0-24 (Rac[AUC0-24]) for AZD8871 and Its Metabolites (Day 16).
LAS34850
|
1.564 Ratio
Interval 1.22 to 2.04
|
1.690 Ratio
Interval 1.55 to 1.9
|
1.463 Ratio
Interval 1.23 to 1.55
|
—
|
Adverse Events
300 μg AZD8871
600 μg AZD8871
900 μg AZD8871
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
300 μg AZD8871
n=6 participants at risk
Participants received a single dose of AZD8871 300 μg on Day 1, followed by once daily dosing on Days 5 to 16.
|
600 μg AZD8871
n=6 participants at risk
Participants received a single dose of 600 μg AZD8871 on Day 1, followed by once daily dosing on Days 5 to 16.
|
900 μg AZD8871
n=6 participants at risk
Participants received a single dose of 900 μg AZD8871 on Day 1, followed by once daily dosing on Days 5 to 16.
|
Placebo
n=6 participants at risk
Participants received a single dose of Placebo on Day 1, followed by once daily dosing on Days 5 to 16.
|
|---|---|---|---|---|
|
General disorders
Vessel puncture site bruise
|
0.00%
0/6 • From baseline to the Follow-up Visit at Days 25-27
The safety analysis population included all subjects who received at least 1 dose of the investigational product and for whom any post-dose safety data were available.
|
0.00%
0/6 • From baseline to the Follow-up Visit at Days 25-27
The safety analysis population included all subjects who received at least 1 dose of the investigational product and for whom any post-dose safety data were available.
|
50.0%
3/6 • Number of events 3 • From baseline to the Follow-up Visit at Days 25-27
The safety analysis population included all subjects who received at least 1 dose of the investigational product and for whom any post-dose safety data were available.
|
33.3%
2/6 • Number of events 2 • From baseline to the Follow-up Visit at Days 25-27
The safety analysis population included all subjects who received at least 1 dose of the investigational product and for whom any post-dose safety data were available.
|
|
General disorders
Vessel puncture site pain
|
0.00%
0/6 • From baseline to the Follow-up Visit at Days 25-27
The safety analysis population included all subjects who received at least 1 dose of the investigational product and for whom any post-dose safety data were available.
|
0.00%
0/6 • From baseline to the Follow-up Visit at Days 25-27
The safety analysis population included all subjects who received at least 1 dose of the investigational product and for whom any post-dose safety data were available.
|
16.7%
1/6 • Number of events 1 • From baseline to the Follow-up Visit at Days 25-27
The safety analysis population included all subjects who received at least 1 dose of the investigational product and for whom any post-dose safety data were available.
|
0.00%
0/6 • From baseline to the Follow-up Visit at Days 25-27
The safety analysis population included all subjects who received at least 1 dose of the investigational product and for whom any post-dose safety data were available.
|
|
Nervous system disorders
Headache
|
33.3%
2/6 • Number of events 2 • From baseline to the Follow-up Visit at Days 25-27
The safety analysis population included all subjects who received at least 1 dose of the investigational product and for whom any post-dose safety data were available.
|
16.7%
1/6 • Number of events 1 • From baseline to the Follow-up Visit at Days 25-27
The safety analysis population included all subjects who received at least 1 dose of the investigational product and for whom any post-dose safety data were available.
|
0.00%
0/6 • From baseline to the Follow-up Visit at Days 25-27
The safety analysis population included all subjects who received at least 1 dose of the investigational product and for whom any post-dose safety data were available.
|
0.00%
0/6 • From baseline to the Follow-up Visit at Days 25-27
The safety analysis population included all subjects who received at least 1 dose of the investigational product and for whom any post-dose safety data were available.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/6 • From baseline to the Follow-up Visit at Days 25-27
The safety analysis population included all subjects who received at least 1 dose of the investigational product and for whom any post-dose safety data were available.
|
0.00%
0/6 • From baseline to the Follow-up Visit at Days 25-27
The safety analysis population included all subjects who received at least 1 dose of the investigational product and for whom any post-dose safety data were available.
|
16.7%
1/6 • Number of events 1 • From baseline to the Follow-up Visit at Days 25-27
The safety analysis population included all subjects who received at least 1 dose of the investigational product and for whom any post-dose safety data were available.
|
0.00%
0/6 • From baseline to the Follow-up Visit at Days 25-27
The safety analysis population included all subjects who received at least 1 dose of the investigational product and for whom any post-dose safety data were available.
|
|
Gastrointestinal disorders
Toothache
|
16.7%
1/6 • Number of events 1 • From baseline to the Follow-up Visit at Days 25-27
The safety analysis population included all subjects who received at least 1 dose of the investigational product and for whom any post-dose safety data were available.
|
0.00%
0/6 • From baseline to the Follow-up Visit at Days 25-27
The safety analysis population included all subjects who received at least 1 dose of the investigational product and for whom any post-dose safety data were available.
|
0.00%
0/6 • From baseline to the Follow-up Visit at Days 25-27
The safety analysis population included all subjects who received at least 1 dose of the investigational product and for whom any post-dose safety data were available.
|
0.00%
0/6 • From baseline to the Follow-up Visit at Days 25-27
The safety analysis population included all subjects who received at least 1 dose of the investigational product and for whom any post-dose safety data were available.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6 • From baseline to the Follow-up Visit at Days 25-27
The safety analysis population included all subjects who received at least 1 dose of the investigational product and for whom any post-dose safety data were available.
|
0.00%
0/6 • From baseline to the Follow-up Visit at Days 25-27
The safety analysis population included all subjects who received at least 1 dose of the investigational product and for whom any post-dose safety data were available.
|
33.3%
2/6 • Number of events 2 • From baseline to the Follow-up Visit at Days 25-27
The safety analysis population included all subjects who received at least 1 dose of the investigational product and for whom any post-dose safety data were available.
|
0.00%
0/6 • From baseline to the Follow-up Visit at Days 25-27
The safety analysis population included all subjects who received at least 1 dose of the investigational product and for whom any post-dose safety data were available.
|
|
Skin and subcutaneous tissue disorders
Contact dermatitis
|
0.00%
0/6 • From baseline to the Follow-up Visit at Days 25-27
The safety analysis population included all subjects who received at least 1 dose of the investigational product and for whom any post-dose safety data were available.
|
0.00%
0/6 • From baseline to the Follow-up Visit at Days 25-27
The safety analysis population included all subjects who received at least 1 dose of the investigational product and for whom any post-dose safety data were available.
|
16.7%
1/6 • Number of events 1 • From baseline to the Follow-up Visit at Days 25-27
The safety analysis population included all subjects who received at least 1 dose of the investigational product and for whom any post-dose safety data were available.
|
0.00%
0/6 • From baseline to the Follow-up Visit at Days 25-27
The safety analysis population included all subjects who received at least 1 dose of the investigational product and for whom any post-dose safety data were available.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
16.7%
1/6 • Number of events 1 • From baseline to the Follow-up Visit at Days 25-27
The safety analysis population included all subjects who received at least 1 dose of the investigational product and for whom any post-dose safety data were available.
|
0.00%
0/6 • From baseline to the Follow-up Visit at Days 25-27
The safety analysis population included all subjects who received at least 1 dose of the investigational product and for whom any post-dose safety data were available.
|
0.00%
0/6 • From baseline to the Follow-up Visit at Days 25-27
The safety analysis population included all subjects who received at least 1 dose of the investigational product and for whom any post-dose safety data were available.
|
0.00%
0/6 • From baseline to the Follow-up Visit at Days 25-27
The safety analysis population included all subjects who received at least 1 dose of the investigational product and for whom any post-dose safety data were available.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/6 • From baseline to the Follow-up Visit at Days 25-27
The safety analysis population included all subjects who received at least 1 dose of the investigational product and for whom any post-dose safety data were available.
|
16.7%
1/6 • Number of events 1 • From baseline to the Follow-up Visit at Days 25-27
The safety analysis population included all subjects who received at least 1 dose of the investigational product and for whom any post-dose safety data were available.
|
0.00%
0/6 • From baseline to the Follow-up Visit at Days 25-27
The safety analysis population included all subjects who received at least 1 dose of the investigational product and for whom any post-dose safety data were available.
|
0.00%
0/6 • From baseline to the Follow-up Visit at Days 25-27
The safety analysis population included all subjects who received at least 1 dose of the investigational product and for whom any post-dose safety data were available.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
16.7%
1/6 • Number of events 1 • From baseline to the Follow-up Visit at Days 25-27
The safety analysis population included all subjects who received at least 1 dose of the investigational product and for whom any post-dose safety data were available.
|
0.00%
0/6 • From baseline to the Follow-up Visit at Days 25-27
The safety analysis population included all subjects who received at least 1 dose of the investigational product and for whom any post-dose safety data were available.
|
0.00%
0/6 • From baseline to the Follow-up Visit at Days 25-27
The safety analysis population included all subjects who received at least 1 dose of the investigational product and for whom any post-dose safety data were available.
|
0.00%
0/6 • From baseline to the Follow-up Visit at Days 25-27
The safety analysis population included all subjects who received at least 1 dose of the investigational product and for whom any post-dose safety data were available.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • From baseline to the Follow-up Visit at Days 25-27
The safety analysis population included all subjects who received at least 1 dose of the investigational product and for whom any post-dose safety data were available.
|
0.00%
0/6 • From baseline to the Follow-up Visit at Days 25-27
The safety analysis population included all subjects who received at least 1 dose of the investigational product and for whom any post-dose safety data were available.
|
0.00%
0/6 • From baseline to the Follow-up Visit at Days 25-27
The safety analysis population included all subjects who received at least 1 dose of the investigational product and for whom any post-dose safety data were available.
|
16.7%
1/6 • Number of events 1 • From baseline to the Follow-up Visit at Days 25-27
The safety analysis population included all subjects who received at least 1 dose of the investigational product and for whom any post-dose safety data were available.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/6 • From baseline to the Follow-up Visit at Days 25-27
The safety analysis population included all subjects who received at least 1 dose of the investigational product and for whom any post-dose safety data were available.
|
0.00%
0/6 • From baseline to the Follow-up Visit at Days 25-27
The safety analysis population included all subjects who received at least 1 dose of the investigational product and for whom any post-dose safety data were available.
|
16.7%
1/6 • Number of events 1 • From baseline to the Follow-up Visit at Days 25-27
The safety analysis population included all subjects who received at least 1 dose of the investigational product and for whom any post-dose safety data were available.
|
0.00%
0/6 • From baseline to the Follow-up Visit at Days 25-27
The safety analysis population included all subjects who received at least 1 dose of the investigational product and for whom any post-dose safety data were available.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • From baseline to the Follow-up Visit at Days 25-27
The safety analysis population included all subjects who received at least 1 dose of the investigational product and for whom any post-dose safety data were available.
|
0.00%
0/6 • From baseline to the Follow-up Visit at Days 25-27
The safety analysis population included all subjects who received at least 1 dose of the investigational product and for whom any post-dose safety data were available.
|
0.00%
0/6 • From baseline to the Follow-up Visit at Days 25-27
The safety analysis population included all subjects who received at least 1 dose of the investigational product and for whom any post-dose safety data were available.
|
16.7%
1/6 • Number of events 1 • From baseline to the Follow-up Visit at Days 25-27
The safety analysis population included all subjects who received at least 1 dose of the investigational product and for whom any post-dose safety data were available.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/6 • From baseline to the Follow-up Visit at Days 25-27
The safety analysis population included all subjects who received at least 1 dose of the investigational product and for whom any post-dose safety data were available.
|
0.00%
0/6 • From baseline to the Follow-up Visit at Days 25-27
The safety analysis population included all subjects who received at least 1 dose of the investigational product and for whom any post-dose safety data were available.
|
0.00%
0/6 • From baseline to the Follow-up Visit at Days 25-27
The safety analysis population included all subjects who received at least 1 dose of the investigational product and for whom any post-dose safety data were available.
|
33.3%
2/6 • Number of events 2 • From baseline to the Follow-up Visit at Days 25-27
The safety analysis population included all subjects who received at least 1 dose of the investigational product and for whom any post-dose safety data were available.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/6 • From baseline to the Follow-up Visit at Days 25-27
The safety analysis population included all subjects who received at least 1 dose of the investigational product and for whom any post-dose safety data were available.
|
0.00%
0/6 • From baseline to the Follow-up Visit at Days 25-27
The safety analysis population included all subjects who received at least 1 dose of the investigational product and for whom any post-dose safety data were available.
|
0.00%
0/6 • From baseline to the Follow-up Visit at Days 25-27
The safety analysis population included all subjects who received at least 1 dose of the investigational product and for whom any post-dose safety data were available.
|
16.7%
1/6 • Number of events 1 • From baseline to the Follow-up Visit at Days 25-27
The safety analysis population included all subjects who received at least 1 dose of the investigational product and for whom any post-dose safety data were available.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Publication and / or presentation whether complete or partial, of any part of the data or results of this study will not be allowed until global publication and study results disclosure by the sponsor as per EMA / FDA regulatory compliance obligations, and only after mutual agreement between the Investigator and AstraZeneca
- Publication restrictions are in place
Restriction type: OTHER