Healthy Subjects (HS)
Conditions
Keywords
Single photon emission computed tomography (SPECT), Healthy Volunteer (HV)
Brief summary
This is a phase 1, single-centre, single-group, nonrandomized, noncomparative, open-label, single-dose study to evaluate the safety, biodistribution, internal radiation dosimetry, and effective dose of DaTSCAN™ ioflupane (123I) injection in Chinese Healthy Volunteers.
Interventions
Each participant will receive a single administration of DaTSCAN™ ioflupane (123I) injection by bolus IV injection with a nominal iodine (123I) activity of 111 MBq ±10%, in a maximum volume of 5 mL.
Sponsors
PPD Development, LP
GE Healthcare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Chinese male or female who has agreed to sign and date the written informed consent form * Age 18-70 years * Body mass index (BMI) of 18-30 kg/m\^2 * General good state of health as judged by a qualified physician after completing physical examination * Fit, co-operative, and able to provide consent
Exclusion criteria
* Sensitivity to DaTSCAN™ ioflupane (123I) injection or any of its ingredients * A history of motor disturbances * A history of pulmonary, cardiovascular, neurological, renal or hepatic, hormonal or coagulation disorders or hyperthyroidism * A history of drug, alcohol, or solvent abuse * The subject has been previously enrolled in this study or participated in a clinical study involving an investigational pharmaceutical product within 30 days prior to screening * Radionuclide injection within a minimum of 5 radioactive half-lives prior to screening * Use of any medication (except paracetamol \[acetaminophen\] or oral contraceptive), including traditional Chinese medicine, within 2 weeks prior to the imaging visit * Classification as a radiation worker * Women of child-bearing potential not accepting a highly effective method of birth control (A woman is considered of child-bearing potential, i.e., fertile, following menarche and until becoming postmenopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. Postmenopausal is defined as 12 months with no menses without an alternative medical cause, in International Council on Harmonisation (ICH) M3 (R2); A highly effective method of birth control is defined as one which results in a low failure rate (i.e., less than 1 % per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, some intrauterine devices, sexual abstinence or vasectomised partner, in ICH M3 (R2). * Pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Electrocardiogram (ECG) Findings at Pre-specified Timepoints | Baseline, 2 and 5 hours after DaTSCAN™ ioflupane (123I) injection | Change from baseline in PR interval, QRS interval, QT interval, QTC interval, RR interval, QTCF interval, QTCB interval were reported. |
| Change From Baseline in Vital Sign-Systolic Blood Pressure at Pre-specified Timepoints | Baseline, 10, 20, 30 minutes and 1, 2, 4, 24, 48 hours and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days) | Change from baseline in systolic blood pressure were reported. |
| Change From Baseline in Vital Sign-Diastolic Blood Pressure at Pre-specified Timepoints | Baseline, 10, 20, 30 minutes and 1, 2, 4, 24, 48 hours and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days) | Change from baseline in diastolic blood pressure were reported. |
| Change From Baseline in Vital Sign-Heart Rate at Pre-specified Timepoints | Baseline, 10, 20, 30 minutes and 1, 2, 4, 24, 48 hours and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days) | Change from baseline in heart rate were reported. |
| Change From Baseline in Vital Sign-Temperature at Pre-specified Timepoints | Baseline, 10, 20, 30 minutes and 1, 2, 4, 24, 48 hours and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days) | Change from baseline in temperature were reported. |
| Change From Baseline in Vital Sign-Respiratory Rate at Pre-specified Timepoints | Baseline, 10, 20, 30 minutes and 1, 2, 4, 24, 48 hours and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days) | Change from baseline in respiratory rate were reported. |
| Change From Baseline in Oxygen Saturation at Pre-specified Timepoints | Baseline, 10, 20, 30 minutes and 1, 2, 4, 24, 48 hours and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days) | Change from baseline in oxygen saturation were reported. |
| Number of Participants With Adverse Events (AEs) | Baseline up to 2 weeks after IMP administration (i.e., up to 16 days) | An AE was defined as any untoward medical occurrence in participants or clinical investigation participant which did not necessarily have to have been related to the investigational medical product (IMP). AEs were recorded from time of informed consent through the follow-up visit at 2 weeks (±2 days) after IMP administration. |
| Change From Baseline in Tolerability Questionnaire Score at Approximately 15 Minutes, 1, 4, 24, 48 Hours After DaTSCAN™ Ioflupane (123I) Injection as Measured by VAS (Visual Analogue Scale) | 1 hour before injection (baseline), and at approximately 15 minutes, 1, 4, 24, 48 hours after DaTSCAN™ ioflupane (123I) injection | Tolerability questionnaire evaluated participants mood, pain at injection site, itchiness of injection site, loss of function at injection site and quality of sleep using 100 millimeter (mm) VAS. VAS is a continuous scale comprised of a horizontal line, usually 100 mm in length, where 0 stands for bad, and 100 mm stands for good. Higher score indicated better health outcomes. |
| Number of Participants With Clinically Significant Change From Baseline in Physical Examination Findings Pre-specified Timepoints | Baseline, 4 hours after injection and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days) | Physical examination included recording an assessment for the presence of abnormalities of the following: general appearance, skin, lungs, cardiovascular system, back and spine, abdomen, extremities, lymph nodes, and neurological exam. Clinical significance was determined by investigator. |
| Change From Baseline in Hematology Parameters at Pre-specified Timepoints | Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days) | Change from baseline in activated partial thromboplastin time, prothrombin time, thrombin time were reported. |
| Change From Baseline in Hematology Parameter-C Reactive Protein at Pre-specified Timepoints | Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days) | Change from baseline in C reactive protein were reported. |
| Change From Baseline in Hematology Parameter-Hematocrit at Pre-specified Timepoints | Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days) | Change from baseline in hematocrit were reported. |
| Change From Baseline in Hematology Parameter-Erythrocytes at Pre-specified Timepoints | Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days) | Change from baseline in erythrocytes were reported. |
| Change From Baseline in Hematology Parameters- Leukocytes, Platelets at Pre-specified Timepoints | Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days) | Change from baseline in leukocytes, platelets timepoints were reported. |
| Change From Baseline in Hematology Parameters- Fibrinogen, Hemoglobin at Pre-specified Timepoints | Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days) | Change from baseline in fibrinogen, hemoglobin were reported. |
| Change From Baseline in Serum Chemistry Parameters- Albumin, Protein at Pre-specified Timepoints | Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days) | Change from baseline in albumin, protein were reported. |
| Change From Baseline in Serum Chemistry Parameters- Thyroxine, Free and Triiodothyronine, Free at Pre-specified Timepoints | Baseline, and at 48 hours after DaTSCAN™ ioflupane (123I) injection | Change from baseline in thyroxine, free and triiodothyronine, free were reported. |
| Change From Baseline in Serum Chemistry Parameters at Pre-specified Timepoints | Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days) | Change from baseline in alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, creatine kinase, gamma glutamyl transferase, lactate dehydrogenase were reported. |
| Change From Baseline in Serum Chemistry Parameters- Thyroxine and Triiodothyronine at Pre-specified Timepoints | Baseline, and at 48 hours after DaTSCAN™ ioflupane (123I) injection | Change from baseline in thyroxine and triiodothyronine were reported. |
| Change From Baseline in Serum Chemistry Parameters- Bilirubin, Creatinine, Direct Bilirubin, and Urate at Pre-specified Timepoints | Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days) | Change from baseline in bilirubin, creatinine, direct bilirubin, and urate were reported. |
| Change From Baseline in Serum Chemistry Parameters- Bicarbonate, Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, Urea Nitrogen at Pre-specified Timepoints | Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days) | Change from baseline in bicarbonate, calcium, chloride, glucose, phosphate, potassium, sodium, urea nitrogen were reported. |
| Change From Baseline in Serum Chemistry Parameters- Thyrotropin at Pre-specified Timepoints | Baseline, and at 48 hours after DaTSCAN™ ioflupane (123I) injection | Change from baseline in thyrotropin were reported. |
| Change From Baseline in Serum Chemistry Parameters- Amylase at Pre-specified Timepoints | Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days) | Change from baseline in amylase were reported. |
| Number of Participants With Clinically Significant Abnormal Urinalysis Parameters - pH and Specific Gravity at Pre-specified Timepoints | Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days) | Number of participants with clinically significant abnormal pH and specific gravity were reported. Clinical significance was determined by investigator. |
| Number of Participants Who Reported Abnormal Injection Site Monitoring Findings at Pre-specified Timepoints | Baseline, up to 4 hours after DaTSCAN™ ioflupane (123I) injection | Any radiopharmaceutical extravasation, bleeding, hematoma, redness, infection, or other findings were considered as abnormal findings. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image | 10 minutes and 1, 2, 4, 5, 24, and 48 hours after DaTSCAN™ ioflupane (123I) injection | The decay-corrected %IA was measured by planar scintigraphy. The biodistribution as measured by the decay-corrected %IA in the whole-body image which included background, heart, intestines, liver, lungs, salivary glands, stomach, striatum, thyroid, whole body, whole brain) at specified timepoints were reported. |
| Biodistribution by Source Regions Measured by Decay Corrected Normalized Cumulative Activity | Up to 48 hours after DaTSCAN™ ioflupane (123I) injection | Biodistribution measured by decay corrected normalized cumulative activity in bladder content, brain, gallbladder, liver, lower large intestine, lungs, remainder, small intestine, upper large intestine was reported. |
| Biodistribution as Measured by Decay-corrected Cumulative 123I Activity Concentration in Excreted Urine | 10 minutes and 1, 2, 3, 4, 5, 5 to 24, and 24 to 48 hours after DaTSCAN™ ioflupane (123I) injection | Excretion of 123I following the IV administration of ioflupane (123I) Injection was determined by measuring the 123I activity within the intestinal contents and the sum of the 123I activities in the voided urine up to 48 hours post-injection. |
| Normalized Organ Absorbed Doses as Measured by Radiation Dosimetry | Up to 48 hours after DaTSCAN™ ioflupane (123I) injection | Sex-averaged normalized organ absorbed doses calculated according to Medical Internal Radiation Dose (MIRD) method. |
| Effective Dose (ED) of Ioflupane (123I) Injection After IV Administration | Up to 48 hours after DaTSCAN™ ioflupane (123I) injection | The ED per unit of administered activity was evaluated from the ensemble of absorbed dose data. |
| Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Blood (Plasma and Whole Blood) | Pre-dose, 5, 15, 30 minutes and 1, 2, 3, 4, 5, 24, and 48 hours after DaTSCAN™ ioflupane (123I) injection | The decay-corrected %IA was measured by planar scintigraphy. The biodistribution as measured by the decay-corrected %IA in the plasma and whole blood at specified timepoints were reported. |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| DaTSCAN™ Ioflupane (123I) Injection Participants received a single administration of DaTSCAN™ ioflupane (123I) injection by bolus IV at Day 1; followed by planar whole-body imaging at 10 minutes, 1 hour, 2 hours, 4 hours, 5 hours, 24 hours, and 48 hours after administration. Brain SPECT imaging was performed at 3 and 6 hours after administration. | 8 |
| Total | 8 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | DaTSCAN™ Ioflupane (123I) Injection |
|---|---|
| Age, Continuous | 31.1 years STANDARD_DEVIATION 7.34 |
| Race/Ethnicity, Customized Ethnicity Han Chinese | 6 Participants |
| Race/Ethnicity, Customized Ethnicity Other | 2 Participants |
| Race/Ethnicity, Customized Race Chinese | 8 Participants |
| Race/Ethnicity, Customized Race Mixed race or non-Chinese | 0 Participants |
| Region of Enrollment China | 8 Participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 8 |
| other Total, other adverse events | 7 / 8 |
| serious Total, serious adverse events | 0 / 8 |
Outcome results
Primary
Change From Baseline in Electrocardiogram (ECG) Findings at Pre-specified Timepoints
Change from baseline in PR interval, QRS interval, QT interval, QTC interval, RR interval, QTCF interval, QTCB interval were reported.
Time frame: Baseline, 2 and 5 hours after DaTSCAN™ ioflupane (123I) injection
Population: The safety population included all participants who received ioflupane (123I) injection. Here, number analyzed signifies participants who were evaluable for given categories at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Electrocardiogram (ECG) Findings at Pre-specified Timepoints | PR Interval: At Baseline | 161.3 milliseconds (msec) | Standard Deviation 27.46 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Electrocardiogram (ECG) Findings at Pre-specified Timepoints | PR Interval: Change at 2 hours | -4.8 milliseconds (msec) | Standard Deviation 10.36 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Electrocardiogram (ECG) Findings at Pre-specified Timepoints | PR Interval: Change at 5 hours | -8.8 milliseconds (msec) | Standard Deviation 12.14 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Electrocardiogram (ECG) Findings at Pre-specified Timepoints | QRS Interval: At Baseline | 93.0 milliseconds (msec) | Standard Deviation 10.09 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Electrocardiogram (ECG) Findings at Pre-specified Timepoints | QRS Interval: Change at 2 hours | -3.5 milliseconds (msec) | Standard Deviation 5.32 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Electrocardiogram (ECG) Findings at Pre-specified Timepoints | QRS Interval: Change at 5 hours | -1.0 milliseconds (msec) | Standard Deviation 3.55 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Electrocardiogram (ECG) Findings at Pre-specified Timepoints | QT Interval: At Baseline | 406.0 milliseconds (msec) | Standard Deviation 25.94 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Electrocardiogram (ECG) Findings at Pre-specified Timepoints | QT Interval: Change at 2 hours | 6.5 milliseconds (msec) | Standard Deviation 7.46 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Electrocardiogram (ECG) Findings at Pre-specified Timepoints | QT Interval: Change at 5 hours | -1.0 milliseconds (msec) | Standard Deviation 14.58 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Electrocardiogram (ECG) Findings at Pre-specified Timepoints | QTC Interval: At Baseline | 419.9 milliseconds (msec) | Standard Deviation 14.62 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Electrocardiogram (ECG) Findings at Pre-specified Timepoints | QTC Interval: Change at 2 hours | -0.3 milliseconds (msec) | Standard Deviation 6.82 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Electrocardiogram (ECG) Findings at Pre-specified Timepoints | QTC Interval: Change at 5 hours | -1.9 milliseconds (msec) | Standard Deviation 7.03 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Electrocardiogram (ECG) Findings at Pre-specified Timepoints | RR Interval: At Baseline | 910.0 milliseconds (msec) | Standard Deviation 141.42 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Electrocardiogram (ECG) Findings at Pre-specified Timepoints | RR Interval: Change at 2 hours | 65.0 milliseconds (msec) | Standard Deviation 60.24 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Electrocardiogram (ECG) Findings at Pre-specified Timepoints | RR Interval: Change at 5 hours | 0.0 milliseconds (msec) | Standard Deviation 109.02 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Electrocardiogram (ECG) Findings at Pre-specified Timepoints | QTCF Interval: At Baseline | 419.9 milliseconds (msec) | Standard Deviation 15.61 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Electrocardiogram (ECG) Findings at Pre-specified Timepoints | QTCF Interval: Change at 2 hours | -3.1 milliseconds (msec) | Standard Deviation 9.4 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Electrocardiogram (ECG) Findings at Pre-specified Timepoints | QTCF Interval: Change at 5 hours | -1.2 milliseconds (msec) | Standard Deviation 7.71 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Electrocardiogram (ECG) Findings at Pre-specified Timepoints | QTCB Interval: At Baseline | 427.6 milliseconds (msec) | Standard Deviation 20.32 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Electrocardiogram (ECG) Findings at Pre-specified Timepoints | QTCB Interval: Change at 2 hours | -8.3 milliseconds (msec) | Standard Deviation 13.35 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Electrocardiogram (ECG) Findings at Pre-specified Timepoints | QTCB Interval: Change at 5 hours | -1.5 milliseconds (msec) | Standard Deviation 14.58 |
Primary
Change From Baseline in Hematology Parameter-C Reactive Protein at Pre-specified Timepoints
Change from baseline in C reactive protein were reported.
Time frame: Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)
Population: The safety population included all participants who received ioflupane (123I) injection.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Hematology Parameter-C Reactive Protein at Pre-specified Timepoints | At Baseline | 0.906 milligrams per liter (mg/L) | Standard Deviation 0.9608 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Hematology Parameter-C Reactive Protein at Pre-specified Timepoints | Change at 3 Hours | -0.106 milligrams per liter (mg/L) | Standard Deviation 1.5956 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Hematology Parameter-C Reactive Protein at Pre-specified Timepoints | Change at 48 Hours | -0.219 milligrams per liter (mg/L) | Standard Deviation 1.1784 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Hematology Parameter-C Reactive Protein at Pre-specified Timepoints | Change at 2 weeks | -0.231 milligrams per liter (mg/L) | Standard Deviation 0.6181 |
Primary
Change From Baseline in Hematology Parameter-Erythrocytes at Pre-specified Timepoints
Change from baseline in erythrocytes were reported.
Time frame: Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)
Population: The safety population included all participants who received ioflupane (123I) injection.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Hematology Parameter-Erythrocytes at Pre-specified Timepoints | At Baseline | 4.711 10^12 cells per liter | Standard Deviation 0.5148 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Hematology Parameter-Erythrocytes at Pre-specified Timepoints | Change at 3 Hours | -0.098 10^12 cells per liter | Standard Deviation 0.1529 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Hematology Parameter-Erythrocytes at Pre-specified Timepoints | Change at 48 Hours | 0.099 10^12 cells per liter | Standard Deviation 0.2898 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Hematology Parameter-Erythrocytes at Pre-specified Timepoints | Change at 2 weeks | -0.143 10^12 cells per liter | Standard Deviation 0.1648 |
Primary
Change From Baseline in Hematology Parameter-Hematocrit at Pre-specified Timepoints
Change from baseline in hematocrit were reported.
Time frame: Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)
Population: The safety population included all participants who received ioflupane (123I) injection.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Hematology Parameter-Hematocrit at Pre-specified Timepoints | At Baseline | 0.4184 percent of red blood cells | Standard Deviation 0.03175 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Hematology Parameter-Hematocrit at Pre-specified Timepoints | Change at 3 Hours | -0.0128 percent of red blood cells | Standard Deviation 0.01855 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Hematology Parameter-Hematocrit at Pre-specified Timepoints | Change at 48 Hours | 0.0075 percent of red blood cells | Standard Deviation 0.02798 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Hematology Parameter-Hematocrit at Pre-specified Timepoints | Change at 2 weeks | -0.0140 percent of red blood cells | Standard Deviation 0.01595 |
Primary
Change From Baseline in Hematology Parameters at Pre-specified Timepoints
Change from baseline in activated partial thromboplastin time, prothrombin time, thrombin time were reported.
Time frame: Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)
Population: The safety population included all participants who received ioflupane (123I) injection.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Hematology Parameters at Pre-specified Timepoints | Activated Partial Thromboplastin Time: At Baseline | 29.68 seconds | Standard Deviation 2.241 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Hematology Parameters at Pre-specified Timepoints | Activated Partial Thromboplastin Time: Change at 3 Hours | -0.40 seconds | Standard Deviation 2.316 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Hematology Parameters at Pre-specified Timepoints | Activated Partial Thromboplastin Time: Change at 48 Hours | 0.06 seconds | Standard Deviation 2.41 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Hematology Parameters at Pre-specified Timepoints | Activated Partial Thromboplastin Time: Change at 2 weeks | 0.11 seconds | Standard Deviation 2.395 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Hematology Parameters at Pre-specified Timepoints | Prothrombin Time: At Baseline | 11.75 seconds | Standard Deviation 0.472 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Hematology Parameters at Pre-specified Timepoints | Prothrombin Time: Change at 3 Hours | -0.16 seconds | Standard Deviation 0.715 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Hematology Parameters at Pre-specified Timepoints | Prothrombin Time: Change at 48 Hours | 0.06 seconds | Standard Deviation 0.37 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Hematology Parameters at Pre-specified Timepoints | Prothrombin Time: Change at 2 weeks | 0.28 seconds | Standard Deviation 0.365 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Hematology Parameters at Pre-specified Timepoints | Thrombin Time: At Baseline | 18.48 seconds | Standard Deviation 1.229 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Hematology Parameters at Pre-specified Timepoints | Thrombin Time: Change at 3 Hours | -0.08 seconds | Standard Deviation 1.753 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Hematology Parameters at Pre-specified Timepoints | Thrombin Time: Change at 48 Hours | -0.08 seconds | Standard Deviation 1.567 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Hematology Parameters at Pre-specified Timepoints | Thrombin Time: Change at 2 weeks | 0.06 seconds | Standard Deviation 1.53 |
Primary
Change From Baseline in Hematology Parameters- Fibrinogen, Hemoglobin at Pre-specified Timepoints
Change from baseline in fibrinogen, hemoglobin were reported.
Time frame: Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)
Population: The safety population included all participants who received ioflupane (123I) injection.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Hematology Parameters- Fibrinogen, Hemoglobin at Pre-specified Timepoints | Fibrinogen: At Baseline | 2.61 grams per liter (g/L) | Standard Deviation 0.47 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Hematology Parameters- Fibrinogen, Hemoglobin at Pre-specified Timepoints | Fibrinogen: Change at 3 Hours | -0.19 grams per liter (g/L) | Standard Deviation 0.344 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Hematology Parameters- Fibrinogen, Hemoglobin at Pre-specified Timepoints | Fibrinogen: Change at 48 Hours | -0.08 grams per liter (g/L) | Standard Deviation 0.48 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Hematology Parameters- Fibrinogen, Hemoglobin at Pre-specified Timepoints | Fibrinogen: Change at 2 weeks | -0.26 grams per liter (g/L) | Standard Deviation 0.518 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Hematology Parameters- Fibrinogen, Hemoglobin at Pre-specified Timepoints | Hemoglobin: At Baseline | 141.3 grams per liter (g/L) | Standard Deviation 13.41 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Hematology Parameters- Fibrinogen, Hemoglobin at Pre-specified Timepoints | Hemoglobin: Change at 3 Hours | -3.3 grams per liter (g/L) | Standard Deviation 6.27 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Hematology Parameters- Fibrinogen, Hemoglobin at Pre-specified Timepoints | Hemoglobin: Change at 48 Hours | 3.5 grams per liter (g/L) | Standard Deviation 10.65 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Hematology Parameters- Fibrinogen, Hemoglobin at Pre-specified Timepoints | Hemoglobin: Change at 2 weeks | -3.0 grams per liter (g/L) | Standard Deviation 4.31 |
Primary
Change From Baseline in Hematology Parameters- Leukocytes, Platelets at Pre-specified Timepoints
Change from baseline in leukocytes, platelets timepoints were reported.
Time frame: Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)
Population: The safety population included all participants who received ioflupane (123I).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Hematology Parameters- Leukocytes, Platelets at Pre-specified Timepoints | Leukocytes: At Baseline | 6.933 10^9 cells per liter | Standard Deviation 1.6311 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Hematology Parameters- Leukocytes, Platelets at Pre-specified Timepoints | Leukocytes: Change at 3 Hours | -0.280 10^9 cells per liter | Standard Deviation 2.2782 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Hematology Parameters- Leukocytes, Platelets at Pre-specified Timepoints | Leukocytes: Change at 48 Hours | -1.173 10^9 cells per liter | Standard Deviation 2.3201 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Hematology Parameters- Leukocytes, Platelets at Pre-specified Timepoints | Leukocytes: Change at 2 weeks | -0.384 10^9 cells per liter | Standard Deviation 2.5467 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Hematology Parameters- Leukocytes, Platelets at Pre-specified Timepoints | Platelets: At Baseline | 255.8 10^9 cells per liter | Standard Deviation 43.82 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Hematology Parameters- Leukocytes, Platelets at Pre-specified Timepoints | Platelets: Change at 3 Hours | -30.1 10^9 cells per liter | Standard Deviation 25.22 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Hematology Parameters- Leukocytes, Platelets at Pre-specified Timepoints | Platelets: Change at 48 Hours | -14.4 10^9 cells per liter | Standard Deviation 30.4 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Hematology Parameters- Leukocytes, Platelets at Pre-specified Timepoints | Platelets: Change at 2 weeks | 0.1 10^9 cells per liter | Standard Deviation 36.04 |
Primary
Change From Baseline in Oxygen Saturation at Pre-specified Timepoints
Change from baseline in oxygen saturation were reported.
Time frame: Baseline, 10, 20, 30 minutes and 1, 2, 4, 24, 48 hours and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)
Population: The safety population included all participants who received ioflupane (123I) injection. Here, number analyzed signifies participants who were evaluable at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Oxygen Saturation at Pre-specified Timepoints | Change at 1 hour | 0.1 percent oxygen (%) | Standard Deviation 1.81 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Oxygen Saturation at Pre-specified Timepoints | At Baseline | 98.0 percent oxygen (%) | Standard Deviation 1.93 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Oxygen Saturation at Pre-specified Timepoints | Change at 10 minutes | -0.5 percent oxygen (%) | Standard Deviation 1.31 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Oxygen Saturation at Pre-specified Timepoints | Change at 20 minutes | 0.0 percent oxygen (%) | Standard Deviation 3.16 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Oxygen Saturation at Pre-specified Timepoints | Change at 30 minutes | -0.8 percent oxygen (%) | Standard Deviation 2.05 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Oxygen Saturation at Pre-specified Timepoints | Change at 2 hours | 0.1 percent oxygen (%) | Standard Deviation 2.47 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Oxygen Saturation at Pre-specified Timepoints | Change at 4 hours | 0.6 percent oxygen (%) | Standard Deviation 2.13 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Oxygen Saturation at Pre-specified Timepoints | Change at 24 hours | 1.0 percent oxygen (%) | Standard Deviation 2.33 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Oxygen Saturation at Pre-specified Timepoints | Change at 48 hours | 0.3 percent oxygen (%) | Standard Deviation 3.01 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Oxygen Saturation at Pre-specified Timepoints | Change at 2 weeks | -0.9 percent oxygen (%) | Standard Deviation 2.23 |
Primary
Change From Baseline in Serum Chemistry Parameters- Albumin, Protein at Pre-specified Timepoints
Change from baseline in albumin, protein were reported.
Time frame: Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)
Population: The safety population included all participants who received ioflupane (123I) injection.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Serum Chemistry Parameters- Albumin, Protein at Pre-specified Timepoints | Albumin: Baseline | 45.8 gram per liter (g/L) | Standard Deviation 2.49 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Serum Chemistry Parameters- Albumin, Protein at Pre-specified Timepoints | Albumin: Change at 3 Hours | -1.3 gram per liter (g/L) | Standard Deviation 2.19 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Serum Chemistry Parameters- Albumin, Protein at Pre-specified Timepoints | Albumin: Change at 48 Hours | 0.3 gram per liter (g/L) | Standard Deviation 2.76 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Serum Chemistry Parameters- Albumin, Protein at Pre-specified Timepoints | Albumin: Change at 2 Weeks | 0.1 gram per liter (g/L) | Standard Deviation 1.13 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Serum Chemistry Parameters- Albumin, Protein at Pre-specified Timepoints | Protein: Baseline | 73.3 gram per liter (g/L) | Standard Deviation 4.03 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Serum Chemistry Parameters- Albumin, Protein at Pre-specified Timepoints | Protein: Change at 3 Hours | -2.1 gram per liter (g/L) | Standard Deviation 3.6 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Serum Chemistry Parameters- Albumin, Protein at Pre-specified Timepoints | Protein: Change at 48 Hours | -0.5 gram per liter (g/L) | Standard Deviation 3.89 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Serum Chemistry Parameters- Albumin, Protein at Pre-specified Timepoints | Protein: Change at 2 Weeks | -2.6 gram per liter (g/L) | Standard Deviation 3.62 |
Primary
Change From Baseline in Serum Chemistry Parameters- Amylase at Pre-specified Timepoints
Change from baseline in amylase were reported.
Time frame: Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)
Population: The safety population included all participants who received ioflupane (123I) injection.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Serum Chemistry Parameters- Amylase at Pre-specified Timepoints | Amylase: Baseline | 77.1 units per liter (U/L) | Standard Deviation 29.53 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Serum Chemistry Parameters- Amylase at Pre-specified Timepoints | Amylase: Change at 3 Hours | 18.9 units per liter (U/L) | Standard Deviation 48.01 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Serum Chemistry Parameters- Amylase at Pre-specified Timepoints | Amylase: Change at 48 Hours | 3.8 units per liter (U/L) | Standard Deviation 10.63 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Serum Chemistry Parameters- Amylase at Pre-specified Timepoints | Amylase: Change at 2 Weeks | 2.0 units per liter (U/L) | Standard Deviation 6.72 |
Primary
Change From Baseline in Serum Chemistry Parameters at Pre-specified Timepoints
Change from baseline in alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, creatine kinase, gamma glutamyl transferase, lactate dehydrogenase were reported.
Time frame: Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)
Population: The safety population included all participants who received ioflupane (123I) injection.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Serum Chemistry Parameters at Pre-specified Timepoints | Alanine aminotransferase; Baseline | 17.6 international units per Liter (IU/L) | Standard Deviation 4.72 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Serum Chemistry Parameters at Pre-specified Timepoints | Alanine aminotransferase: Change at 3 Hours | -0.1 international units per Liter (IU/L) | Standard Deviation 4.26 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Serum Chemistry Parameters at Pre-specified Timepoints | Alanine aminotransferase: Change at 48 Hours | -1.6 international units per Liter (IU/L) | Standard Deviation 5.29 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Serum Chemistry Parameters at Pre-specified Timepoints | Alanine aminotransferase: Change at 2 weeks | -1.4 international units per Liter (IU/L) | Standard Deviation 7.01 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Serum Chemistry Parameters at Pre-specified Timepoints | Alkaline phosphatase: Baseline | 72.3 international units per Liter (IU/L) | Standard Deviation 22.04 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Serum Chemistry Parameters at Pre-specified Timepoints | Alkaline phosphatase: Change at 3 Hours | -3.9 international units per Liter (IU/L) | Standard Deviation 7.55 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Serum Chemistry Parameters at Pre-specified Timepoints | Alkaline phosphatase: Change at 48 Hours | 2.8 international units per Liter (IU/L) | Standard Deviation 5.85 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Serum Chemistry Parameters at Pre-specified Timepoints | Alkaline phosphatase: Change at 2 weeks | -1.4 international units per Liter (IU/L) | Standard Deviation 5.4 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Serum Chemistry Parameters at Pre-specified Timepoints | Aspartate aminotransferase: Baseline | 20.8 international units per Liter (IU/L) | Standard Deviation 3.41 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Serum Chemistry Parameters at Pre-specified Timepoints | Aspartate aminotransferase: Change at 3 Hours | 4.8 international units per Liter (IU/L) | Standard Deviation 9.02 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Serum Chemistry Parameters at Pre-specified Timepoints | Aspartate aminotransferase: Change at 48 Hours | 0.5 international units per Liter (IU/L) | Standard Deviation 5.83 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Serum Chemistry Parameters at Pre-specified Timepoints | Aspartate aminotransferase: Change at 2 weeks | 3.1 international units per Liter (IU/L) | Standard Deviation 11.73 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Serum Chemistry Parameters at Pre-specified Timepoints | Creatine kinase: Baseline | 128.5 international units per Liter (IU/L) | Standard Deviation 102.11 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Serum Chemistry Parameters at Pre-specified Timepoints | Creatine kinase: Change at 3 Hours | 11.4 international units per Liter (IU/L) | Standard Deviation 38.95 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Serum Chemistry Parameters at Pre-specified Timepoints | Creatine kinase: Change at 48 Hours | -46.5 international units per Liter (IU/L) | Standard Deviation 67.83 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Serum Chemistry Parameters at Pre-specified Timepoints | Creatine kinase: Change at 2 weeks | 599.6 international units per Liter (IU/L) | Standard Deviation 1749.92 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Serum Chemistry Parameters at Pre-specified Timepoints | Gamma glutamyl transferase: Baseline | 17.1 international units per Liter (IU/L) | Standard Deviation 6.98 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Serum Chemistry Parameters at Pre-specified Timepoints | Gamma glutamyl transferase: Change at 3 Hours | -1.8 international units per Liter (IU/L) | Standard Deviation 1.83 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Serum Chemistry Parameters at Pre-specified Timepoints | Gamma glutamyl transferase: Change at 48 Hours | -0.8 international units per Liter (IU/L) | Standard Deviation 2.25 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Serum Chemistry Parameters at Pre-specified Timepoints | Gamma glutamyl transferase: Change at 2 weeks | -0.8 international units per Liter (IU/L) | Standard Deviation 1.75 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Serum Chemistry Parameters at Pre-specified Timepoints | Lactate dehydrogenase: Baseline | 173.0 international units per Liter (IU/L) | Standard Deviation 45.69 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Serum Chemistry Parameters at Pre-specified Timepoints | Lactate dehydrogenase: Change at 3 Hours | 33.3 international units per Liter (IU/L) | Standard Deviation 61.16 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Serum Chemistry Parameters at Pre-specified Timepoints | Lactate dehydrogenase: Change at 48 Hours | 12.1 international units per Liter (IU/L) | Standard Deviation 46.1 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Serum Chemistry Parameters at Pre-specified Timepoints | Lactate dehydrogenase: Change at 2 weeks | 39.1 international units per Liter (IU/L) | Standard Deviation 72.71 |
Primary
Change From Baseline in Serum Chemistry Parameters- Bicarbonate, Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, Urea Nitrogen at Pre-specified Timepoints
Change from baseline in bicarbonate, calcium, chloride, glucose, phosphate, potassium, sodium, urea nitrogen were reported.
Time frame: Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)
Population: The safety population included all participants who received ioflupane (123I) injection. Here, number analyzed signifies participants who were evaluable for given categories at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Serum Chemistry Parameters- Bicarbonate, Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, Urea Nitrogen at Pre-specified Timepoints | Bicarbonate: Baseline | 25.31 millimoles per liter (mmol/L) | Standard Deviation 1.912 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Serum Chemistry Parameters- Bicarbonate, Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, Urea Nitrogen at Pre-specified Timepoints | Bicarbonate: Change at 3 Hours | 1.04 millimoles per liter (mmol/L) | Standard Deviation 3.036 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Serum Chemistry Parameters- Bicarbonate, Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, Urea Nitrogen at Pre-specified Timepoints | Bicarbonate: Change at 48 Hours | 1.87 millimoles per liter (mmol/L) | Standard Deviation 2.757 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Serum Chemistry Parameters- Bicarbonate, Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, Urea Nitrogen at Pre-specified Timepoints | Bicarbonate: Change at 2 weeks | 1.40 millimoles per liter (mmol/L) | Standard Deviation 2.198 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Serum Chemistry Parameters- Bicarbonate, Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, Urea Nitrogen at Pre-specified Timepoints | Calcium: Baseline | 2.355 millimoles per liter (mmol/L) | Standard Deviation 0.1207 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Serum Chemistry Parameters- Bicarbonate, Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, Urea Nitrogen at Pre-specified Timepoints | Calcium: Change at 3 Hours | -0.035 millimoles per liter (mmol/L) | Standard Deviation 0.1214 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Serum Chemistry Parameters- Bicarbonate, Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, Urea Nitrogen at Pre-specified Timepoints | Calcium: Change at 48 Hours | 0.021 millimoles per liter (mmol/L) | Standard Deviation 0.1203 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Serum Chemistry Parameters- Bicarbonate, Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, Urea Nitrogen at Pre-specified Timepoints | Calcium: Change at 2 weeks | -0.030 millimoles per liter (mmol/L) | Standard Deviation 0.139 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Serum Chemistry Parameters- Bicarbonate, Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, Urea Nitrogen at Pre-specified Timepoints | Chloride: Baseline | 103.0 millimoles per liter (mmol/L) | Standard Deviation 1.69 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Serum Chemistry Parameters- Bicarbonate, Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, Urea Nitrogen at Pre-specified Timepoints | Chloride: Change at 3 Hours | -0.3 millimoles per liter (mmol/L) | Standard Deviation 3.2 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Serum Chemistry Parameters- Bicarbonate, Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, Urea Nitrogen at Pre-specified Timepoints | Chloride: Change at 48 Hours | 0.0 millimoles per liter (mmol/L) | Standard Deviation 2.51 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Serum Chemistry Parameters- Bicarbonate, Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, Urea Nitrogen at Pre-specified Timepoints | Chloride: Change at 2 weeks | 1.3 millimoles per liter (mmol/L) | Standard Deviation 2.25 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Serum Chemistry Parameters- Bicarbonate, Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, Urea Nitrogen at Pre-specified Timepoints | Glucose: Baseline | 4.623 millimoles per liter (mmol/L) | Standard Deviation 0.706 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Serum Chemistry Parameters- Bicarbonate, Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, Urea Nitrogen at Pre-specified Timepoints | Glucose: Change at 3 Hours | 0.948 millimoles per liter (mmol/L) | Standard Deviation 0.5832 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Serum Chemistry Parameters- Bicarbonate, Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, Urea Nitrogen at Pre-specified Timepoints | Glucose: Change at 48 Hours | 0.073 millimoles per liter (mmol/L) | Standard Deviation 0.6025 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Serum Chemistry Parameters- Bicarbonate, Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, Urea Nitrogen at Pre-specified Timepoints | Glucose: Change at 2 weeks | 0.924 millimoles per liter (mmol/L) | Standard Deviation 0.7686 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Serum Chemistry Parameters- Bicarbonate, Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, Urea Nitrogen at Pre-specified Timepoints | Phosphate: Baseline | 1.089 millimoles per liter (mmol/L) | Standard Deviation 0.2398 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Serum Chemistry Parameters- Bicarbonate, Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, Urea Nitrogen at Pre-specified Timepoints | Phosphate: Change at 3 Hours | 0.024 millimoles per liter (mmol/L) | Standard Deviation 0.2585 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Serum Chemistry Parameters- Bicarbonate, Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, Urea Nitrogen at Pre-specified Timepoints | Phosphate: Change at 48 Hours | 0.029 millimoles per liter (mmol/L) | Standard Deviation 0.1745 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Serum Chemistry Parameters- Bicarbonate, Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, Urea Nitrogen at Pre-specified Timepoints | Phosphate: Change at 2 weeks | 0.013 millimoles per liter (mmol/L) | Standard Deviation 0.2926 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Serum Chemistry Parameters- Bicarbonate, Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, Urea Nitrogen at Pre-specified Timepoints | Potassium: Baseline | 4.051 millimoles per liter (mmol/L) | Standard Deviation 0.2849 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Serum Chemistry Parameters- Bicarbonate, Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, Urea Nitrogen at Pre-specified Timepoints | Potassium: Change at 3 Hours | 0.151 millimoles per liter (mmol/L) | Standard Deviation 0.4158 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Serum Chemistry Parameters- Bicarbonate, Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, Urea Nitrogen at Pre-specified Timepoints | Potassium: Change at 48 Hours | 0.021 millimoles per liter (mmol/L) | Standard Deviation 0.4538 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Serum Chemistry Parameters- Bicarbonate, Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, Urea Nitrogen at Pre-specified Timepoints | Potassium: Change at 2 weeks | -0.108 millimoles per liter (mmol/L) | Standard Deviation 0.2556 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Serum Chemistry Parameters- Bicarbonate, Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, Urea Nitrogen at Pre-specified Timepoints | Sodium: Baseline | 139.6 millimoles per liter (mmol/L) | Standard Deviation 2.2 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Serum Chemistry Parameters- Bicarbonate, Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, Urea Nitrogen at Pre-specified Timepoints | Sodium: Change at 3 Hours | -1.9 millimoles per liter (mmol/L) | Standard Deviation 2.17 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Serum Chemistry Parameters- Bicarbonate, Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, Urea Nitrogen at Pre-specified Timepoints | Sodium: Change at 48 Hours | 0.4 millimoles per liter (mmol/L) | Standard Deviation 2.56 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Serum Chemistry Parameters- Bicarbonate, Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, Urea Nitrogen at Pre-specified Timepoints | Sodium: Change at 2 weeks | 1.3 millimoles per liter (mmol/L) | Standard Deviation 2.87 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Serum Chemistry Parameters- Bicarbonate, Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, Urea Nitrogen at Pre-specified Timepoints | Urea Nitrogen: Baseline | 4.91 millimoles per liter (mmol/L) | Standard Deviation 1.563 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Serum Chemistry Parameters- Bicarbonate, Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, Urea Nitrogen at Pre-specified Timepoints | Urea Nitrogen: Change at 3 Hours | -0.13 millimoles per liter (mmol/L) | Standard Deviation 1.195 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Serum Chemistry Parameters- Bicarbonate, Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, Urea Nitrogen at Pre-specified Timepoints | Urea Nitrogen: Change at 48 Hours | 0.46 millimoles per liter (mmol/L) | Standard Deviation 1.421 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Serum Chemistry Parameters- Bicarbonate, Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, Urea Nitrogen at Pre-specified Timepoints | Urea Nitrogen: Change at 2 weeks | 1.03 millimoles per liter (mmol/L) | Standard Deviation 1.336 |
Primary
Change From Baseline in Serum Chemistry Parameters- Bilirubin, Creatinine, Direct Bilirubin, and Urate at Pre-specified Timepoints
Change from baseline in bilirubin, creatinine, direct bilirubin, and urate were reported.
Time frame: Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)
Population: The safety population included all participants who received ioflupane (123I) injection.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Serum Chemistry Parameters- Bilirubin, Creatinine, Direct Bilirubin, and Urate at Pre-specified Timepoints | Bilirubin: Baseline | 15.21 micromole per litre (umol/L) | Standard Deviation 6.316 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Serum Chemistry Parameters- Bilirubin, Creatinine, Direct Bilirubin, and Urate at Pre-specified Timepoints | Bilirubin: Change at 3 Hours | -1.54 micromole per litre (umol/L) | Standard Deviation 6.135 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Serum Chemistry Parameters- Bilirubin, Creatinine, Direct Bilirubin, and Urate at Pre-specified Timepoints | Bilirubin: Change at 48 Hours | -1.70 micromole per litre (umol/L) | Standard Deviation 5.478 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Serum Chemistry Parameters- Bilirubin, Creatinine, Direct Bilirubin, and Urate at Pre-specified Timepoints | Bilirubin: Change at 2 Weeks | -1.30 micromole per litre (umol/L) | Standard Deviation 3.747 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Serum Chemistry Parameters- Bilirubin, Creatinine, Direct Bilirubin, and Urate at Pre-specified Timepoints | Creatinine: Baseline | 71.9 micromole per litre (umol/L) | Standard Deviation 17.5 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Serum Chemistry Parameters- Bilirubin, Creatinine, Direct Bilirubin, and Urate at Pre-specified Timepoints | Creatinine: Change at 3 Hours | -10.5 micromole per litre (umol/L) | Standard Deviation 8.37 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Serum Chemistry Parameters- Bilirubin, Creatinine, Direct Bilirubin, and Urate at Pre-specified Timepoints | Creatinine: Change at 48 Hours | -2.9 micromole per litre (umol/L) | Standard Deviation 7.14 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Serum Chemistry Parameters- Bilirubin, Creatinine, Direct Bilirubin, and Urate at Pre-specified Timepoints | Creatinine: Change at 2 Weeks | 1.8 micromole per litre (umol/L) | Standard Deviation 11.47 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Serum Chemistry Parameters- Bilirubin, Creatinine, Direct Bilirubin, and Urate at Pre-specified Timepoints | Direct Bilirubin: Baseline | 2.69 micromole per litre (umol/L) | Standard Deviation 0.958 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Serum Chemistry Parameters- Bilirubin, Creatinine, Direct Bilirubin, and Urate at Pre-specified Timepoints | Direct Bilirubin: Change at 3 Hours | -0.20 micromole per litre (umol/L) | Standard Deviation 1.056 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Serum Chemistry Parameters- Bilirubin, Creatinine, Direct Bilirubin, and Urate at Pre-specified Timepoints | Direct Bilirubin: Change at 48 Hours | -0.23 micromole per litre (umol/L) | Standard Deviation 1.053 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Serum Chemistry Parameters- Bilirubin, Creatinine, Direct Bilirubin, and Urate at Pre-specified Timepoints | Direct Bilirubin: Change at 2 Weeks | -0.05 micromole per litre (umol/L) | Standard Deviation 0.713 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Serum Chemistry Parameters- Bilirubin, Creatinine, Direct Bilirubin, and Urate at Pre-specified Timepoints | Urate: Baseline | 305.1 micromole per litre (umol/L) | Standard Deviation 64.21 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Serum Chemistry Parameters- Bilirubin, Creatinine, Direct Bilirubin, and Urate at Pre-specified Timepoints | Urate: Change at 3 Hours | -42.6 micromole per litre (umol/L) | Standard Deviation 25.26 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Serum Chemistry Parameters- Bilirubin, Creatinine, Direct Bilirubin, and Urate at Pre-specified Timepoints | Urate: Change at 48 Hours | 5.8 micromole per litre (umol/L) | Standard Deviation 30.44 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Serum Chemistry Parameters- Bilirubin, Creatinine, Direct Bilirubin, and Urate at Pre-specified Timepoints | Urate: Change at 2 Weeks | 14.5 micromole per litre (umol/L) | Standard Deviation 34.24 |
Primary
Change From Baseline in Serum Chemistry Parameters- Thyrotropin at Pre-specified Timepoints
Change from baseline in thyrotropin were reported.
Time frame: Baseline, and at 48 hours after DaTSCAN™ ioflupane (123I) injection
Population: The safety population included all participants who received ioflupane (123I) injection.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Serum Chemistry Parameters- Thyrotropin at Pre-specified Timepoints | Thyrotropin: Baseline | 2.50395 milli-international units per liter | Standard Deviation 2.052725 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Serum Chemistry Parameters- Thyrotropin at Pre-specified Timepoints | Thyrotropin: Change at 48 Hours | 0.33034 milli-international units per liter | Standard Deviation 0.87905 |
Primary
Change From Baseline in Serum Chemistry Parameters- Thyroxine and Triiodothyronine at Pre-specified Timepoints
Change from baseline in thyroxine and triiodothyronine were reported.
Time frame: Baseline, and at 48 hours after DaTSCAN™ ioflupane (123I) injection
Population: The safety population included all participants who received ioflupane (123I) injection.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Serum Chemistry Parameters- Thyroxine and Triiodothyronine at Pre-specified Timepoints | Thyroxine: Baseline | 91.024 nanomoles per litre (nmol/L) | Standard Deviation 20.5161 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Serum Chemistry Parameters- Thyroxine and Triiodothyronine at Pre-specified Timepoints | Thyroxine: Change at 48 Hours | -1.670 nanomoles per litre (nmol/L) | Standard Deviation 9.39 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Serum Chemistry Parameters- Thyroxine and Triiodothyronine at Pre-specified Timepoints | Triiodothyronine: Baseline | 1.458 nanomoles per litre (nmol/L) | Standard Deviation 0.2931 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Serum Chemistry Parameters- Thyroxine and Triiodothyronine at Pre-specified Timepoints | Triiodothyronine: Change at 48 Hours | -0.035 nanomoles per litre (nmol/L) | Standard Deviation 0.2484 |
Primary
Change From Baseline in Serum Chemistry Parameters- Thyroxine, Free and Triiodothyronine, Free at Pre-specified Timepoints
Change from baseline in thyroxine, free and triiodothyronine, free were reported.
Time frame: Baseline, and at 48 hours after DaTSCAN™ ioflupane (123I) injection
Population: The safety population included all participants who received ioflupane (123I) injection.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Serum Chemistry Parameters- Thyroxine, Free and Triiodothyronine, Free at Pre-specified Timepoints | Thyroxine, Free: Baseline | 12.580 picomoles per liter (pmol/L) | Standard Deviation 1.8109 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Serum Chemistry Parameters- Thyroxine, Free and Triiodothyronine, Free at Pre-specified Timepoints | Thyroxine, Free: Change at 48 Hours | -0.208 picomoles per liter (pmol/L) | Standard Deviation 0.6362 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Serum Chemistry Parameters- Thyroxine, Free and Triiodothyronine, Free at Pre-specified Timepoints | Triiodothyronine, Free: Baseline | 4.400 picomoles per liter (pmol/L) | Standard Deviation 0.354 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Serum Chemistry Parameters- Thyroxine, Free and Triiodothyronine, Free at Pre-specified Timepoints | Triiodothyronine, Free: Change at 48 Hours | -0.179 picomoles per liter (pmol/L) | Standard Deviation 0.4639 |
Primary
Change From Baseline in Tolerability Questionnaire Score at Approximately 15 Minutes, 1, 4, 24, 48 Hours After DaTSCAN™ Ioflupane (123I) Injection as Measured by VAS (Visual Analogue Scale)
Tolerability questionnaire evaluated participants mood, pain at injection site, itchiness of injection site, loss of function at injection site and quality of sleep using 100 millimeter (mm) VAS. VAS is a continuous scale comprised of a horizontal line, usually 100 mm in length, where 0 stands for bad, and 100 mm stands for good. Higher score indicated better health outcomes.
Time frame: 1 hour before injection (baseline), and at approximately 15 minutes, 1, 4, 24, 48 hours after DaTSCAN™ ioflupane (123I) injection
Population: The safety population included all participants who received ioflupane (123I) injection. Here, number analyzed signifies participants who were evaluable for given categories at specified timepoints and 0 in the number analyzed field denotes that none of the participants were assessed at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Tolerability Questionnaire Score at Approximately 15 Minutes, 1, 4, 24, 48 Hours After DaTSCAN™ Ioflupane (123I) Injection as Measured by VAS (Visual Analogue Scale) | Itchiness of Injection Site: At Baseline | 0.0 millimeter (mm) | Standard Deviation 0 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Tolerability Questionnaire Score at Approximately 15 Minutes, 1, 4, 24, 48 Hours After DaTSCAN™ Ioflupane (123I) Injection as Measured by VAS (Visual Analogue Scale) | Itchiness of Injection Site: Change at 15 minutes | 0.1 millimeter (mm) | Standard Deviation 0.35 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Tolerability Questionnaire Score at Approximately 15 Minutes, 1, 4, 24, 48 Hours After DaTSCAN™ Ioflupane (123I) Injection as Measured by VAS (Visual Analogue Scale) | Itchiness of Injection Site: Change at 1 hour | 0.1 millimeter (mm) | Standard Deviation 0.35 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Tolerability Questionnaire Score at Approximately 15 Minutes, 1, 4, 24, 48 Hours After DaTSCAN™ Ioflupane (123I) Injection as Measured by VAS (Visual Analogue Scale) | Itchiness of Injection Site: Change at 4 hours | 0.1 millimeter (mm) | Standard Deviation 0.35 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Tolerability Questionnaire Score at Approximately 15 Minutes, 1, 4, 24, 48 Hours After DaTSCAN™ Ioflupane (123I) Injection as Measured by VAS (Visual Analogue Scale) | Itchiness of Injection Site: Change at 24 hours | 0.0 millimeter (mm) | Standard Deviation 0 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Tolerability Questionnaire Score at Approximately 15 Minutes, 1, 4, 24, 48 Hours After DaTSCAN™ Ioflupane (123I) Injection as Measured by VAS (Visual Analogue Scale) | Itchiness of Injection Site: Change at 48 hours | 0.0 millimeter (mm) | Standard Deviation 0 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Tolerability Questionnaire Score at Approximately 15 Minutes, 1, 4, 24, 48 Hours After DaTSCAN™ Ioflupane (123I) Injection as Measured by VAS (Visual Analogue Scale) | Loss of Function at Injection Site: At Baseline | 0.0 millimeter (mm) | Standard Deviation 0 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Tolerability Questionnaire Score at Approximately 15 Minutes, 1, 4, 24, 48 Hours After DaTSCAN™ Ioflupane (123I) Injection as Measured by VAS (Visual Analogue Scale) | Loss of Function at Injection Site: Change at 15 minutes | 0.0 millimeter (mm) | Standard Deviation 0 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Tolerability Questionnaire Score at Approximately 15 Minutes, 1, 4, 24, 48 Hours After DaTSCAN™ Ioflupane (123I) Injection as Measured by VAS (Visual Analogue Scale) | Loss of Function at Injection Site: Change at 1 hour | 0.0 millimeter (mm) | Standard Deviation 0 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Tolerability Questionnaire Score at Approximately 15 Minutes, 1, 4, 24, 48 Hours After DaTSCAN™ Ioflupane (123I) Injection as Measured by VAS (Visual Analogue Scale) | Loss of Function at Injection Site: Change at 4 hours | 0.0 millimeter (mm) | Standard Deviation 0 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Tolerability Questionnaire Score at Approximately 15 Minutes, 1, 4, 24, 48 Hours After DaTSCAN™ Ioflupane (123I) Injection as Measured by VAS (Visual Analogue Scale) | Loss of Function at Injection Site: Change at 24 hours | 0.0 millimeter (mm) | Standard Deviation 0 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Tolerability Questionnaire Score at Approximately 15 Minutes, 1, 4, 24, 48 Hours After DaTSCAN™ Ioflupane (123I) Injection as Measured by VAS (Visual Analogue Scale) | Loss of Function at Injection Site: Change at 48 hours | 0.0 millimeter (mm) | Standard Deviation 0 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Tolerability Questionnaire Score at Approximately 15 Minutes, 1, 4, 24, 48 Hours After DaTSCAN™ Ioflupane (123I) Injection as Measured by VAS (Visual Analogue Scale) | Pain at Injection Site: At Baseline | 0.3 millimeter (mm) | Standard Deviation 0.71 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Tolerability Questionnaire Score at Approximately 15 Minutes, 1, 4, 24, 48 Hours After DaTSCAN™ Ioflupane (123I) Injection as Measured by VAS (Visual Analogue Scale) | Pain at Injection Site: Change at 15 minutes | 3.1 millimeter (mm) | Standard Deviation 7.88 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Tolerability Questionnaire Score at Approximately 15 Minutes, 1, 4, 24, 48 Hours After DaTSCAN™ Ioflupane (123I) Injection as Measured by VAS (Visual Analogue Scale) | Pain at Injection Site: Change at 1 hour | -0.3 millimeter (mm) | Standard Deviation 0.71 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Tolerability Questionnaire Score at Approximately 15 Minutes, 1, 4, 24, 48 Hours After DaTSCAN™ Ioflupane (123I) Injection as Measured by VAS (Visual Analogue Scale) | Pain at Injection Site: Change at 4 hours | -0.3 millimeter (mm) | Standard Deviation 0.71 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Tolerability Questionnaire Score at Approximately 15 Minutes, 1, 4, 24, 48 Hours After DaTSCAN™ Ioflupane (123I) Injection as Measured by VAS (Visual Analogue Scale) | Pain at Injection Site: Change at 24 hours | -0.3 millimeter (mm) | Standard Deviation 0.71 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Tolerability Questionnaire Score at Approximately 15 Minutes, 1, 4, 24, 48 Hours After DaTSCAN™ Ioflupane (123I) Injection as Measured by VAS (Visual Analogue Scale) | Pain at Injection Site: Change at 48 hours | -0.3 millimeter (mm) | Standard Deviation 0.71 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Tolerability Questionnaire Score at Approximately 15 Minutes, 1, 4, 24, 48 Hours After DaTSCAN™ Ioflupane (123I) Injection as Measured by VAS (Visual Analogue Scale) | Quality of Sleep: At Baseline | 90.4 millimeter (mm) | Standard Deviation 14.55 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Tolerability Questionnaire Score at Approximately 15 Minutes, 1, 4, 24, 48 Hours After DaTSCAN™ Ioflupane (123I) Injection as Measured by VAS (Visual Analogue Scale) | Quality of Sleep: Change at 24 hours | 6.7 millimeter (mm) | Standard Deviation 11.69 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Tolerability Questionnaire Score at Approximately 15 Minutes, 1, 4, 24, 48 Hours After DaTSCAN™ Ioflupane (123I) Injection as Measured by VAS (Visual Analogue Scale) | Quality of Sleep: Change at 48 hours | 7.8 millimeter (mm) | Standard Deviation 12.34 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Tolerability Questionnaire Score at Approximately 15 Minutes, 1, 4, 24, 48 Hours After DaTSCAN™ Ioflupane (123I) Injection as Measured by VAS (Visual Analogue Scale) | Volunteer Mood: At Baseline | 89.0 millimeter (mm) | Standard Deviation 11.38 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Tolerability Questionnaire Score at Approximately 15 Minutes, 1, 4, 24, 48 Hours After DaTSCAN™ Ioflupane (123I) Injection as Measured by VAS (Visual Analogue Scale) | Volunteer Mood: Change at 15 minutes | 4.9 millimeter (mm) | Standard Deviation 6.31 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Tolerability Questionnaire Score at Approximately 15 Minutes, 1, 4, 24, 48 Hours After DaTSCAN™ Ioflupane (123I) Injection as Measured by VAS (Visual Analogue Scale) | Volunteer Mood: Change at 1 hour | 6.0 millimeter (mm) | Standard Deviation 11.82 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Tolerability Questionnaire Score at Approximately 15 Minutes, 1, 4, 24, 48 Hours After DaTSCAN™ Ioflupane (123I) Injection as Measured by VAS (Visual Analogue Scale) | Volunteer Mood: Change at 4 hours | 3.5 millimeter (mm) | Standard Deviation 7.69 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Tolerability Questionnaire Score at Approximately 15 Minutes, 1, 4, 24, 48 Hours After DaTSCAN™ Ioflupane (123I) Injection as Measured by VAS (Visual Analogue Scale) | Volunteer Mood: Change at 24 hours | 7.9 millimeter (mm) | Standard Deviation 9.73 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Tolerability Questionnaire Score at Approximately 15 Minutes, 1, 4, 24, 48 Hours After DaTSCAN™ Ioflupane (123I) Injection as Measured by VAS (Visual Analogue Scale) | Volunteer Mood: Change at 48 hours | 7.0 millimeter (mm) | Standard Deviation 10.47 |
Primary
Change From Baseline in Vital Sign-Diastolic Blood Pressure at Pre-specified Timepoints
Change from baseline in diastolic blood pressure were reported.
Time frame: Baseline, 10, 20, 30 minutes and 1, 2, 4, 24, 48 hours and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)
Population: The safety population included all participants who received ioflupane (123I) injection. Here, number analyzed signifies participants who were evaluable at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Vital Sign-Diastolic Blood Pressure at Pre-specified Timepoints | At Baseline | 77.8 mmHg | Standard Deviation 5.39 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Vital Sign-Diastolic Blood Pressure at Pre-specified Timepoints | Change at 10 minutes | -3.3 mmHg | Standard Deviation 4.74 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Vital Sign-Diastolic Blood Pressure at Pre-specified Timepoints | Change at 20 minutes | -3.6 mmHg | Standard Deviation 5.68 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Vital Sign-Diastolic Blood Pressure at Pre-specified Timepoints | Change at 30 minutes | -5.5 mmHg | Standard Deviation 8.28 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Vital Sign-Diastolic Blood Pressure at Pre-specified Timepoints | Change at 1 hour | -2.3 mmHg | Standard Deviation 7.98 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Vital Sign-Diastolic Blood Pressure at Pre-specified Timepoints | Change at 2 hours | -1.8 mmHg | Standard Deviation 9.66 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Vital Sign-Diastolic Blood Pressure at Pre-specified Timepoints | Change at 4 hours | -3.3 mmHg | Standard Deviation 7.38 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Vital Sign-Diastolic Blood Pressure at Pre-specified Timepoints | Change at 24 hours | -4.4 mmHg | Standard Deviation 5.18 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Vital Sign-Diastolic Blood Pressure at Pre-specified Timepoints | Change at 48 hours | 0.0 mmHg | Standard Deviation 5.66 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Vital Sign-Diastolic Blood Pressure at Pre-specified Timepoints | Change at 2 weeks | -2.9 mmHg | Standard Deviation 6.73 |
Primary
Change From Baseline in Vital Sign-Heart Rate at Pre-specified Timepoints
Change from baseline in heart rate were reported.
Time frame: Baseline, 10, 20, 30 minutes and 1, 2, 4, 24, 48 hours and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)
Population: The safety population included all participants who received ioflupane (123I) injection. Here, number analyzed signifies participants who were evaluable at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Vital Sign-Heart Rate at Pre-specified Timepoints | At Baseline | 74.4 beats/min | Standard Deviation 12.84 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Vital Sign-Heart Rate at Pre-specified Timepoints | Change at 10 minutes | 0.0 beats/min | Standard Deviation 10.49 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Vital Sign-Heart Rate at Pre-specified Timepoints | Change at 20 minutes | -2.1 beats/min | Standard Deviation 7.4 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Vital Sign-Heart Rate at Pre-specified Timepoints | Change at 30 minutes | -4.6 beats/min | Standard Deviation 9.9 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Vital Sign-Heart Rate at Pre-specified Timepoints | Change at 1 hour | -5.9 beats/min | Standard Deviation 9.61 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Vital Sign-Heart Rate at Pre-specified Timepoints | Change at 2 hours | -4.0 beats/min | Standard Deviation 5.61 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Vital Sign-Heart Rate at Pre-specified Timepoints | Change at 4 hours | 0.0 beats/min | Standard Deviation 6.89 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Vital Sign-Heart Rate at Pre-specified Timepoints | Change at 24 hours | -2.6 beats/min | Standard Deviation 8.25 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Vital Sign-Heart Rate at Pre-specified Timepoints | Change at 48 hours | 0.0 beats/min | Standard Deviation 9.46 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Vital Sign-Heart Rate at Pre-specified Timepoints | Change at 2 weeks | 11.5 beats/min | Standard Deviation 11.71 |
Primary
Change From Baseline in Vital Sign-Respiratory Rate at Pre-specified Timepoints
Change from baseline in respiratory rate were reported.
Time frame: Baseline, 10, 20, 30 minutes and 1, 2, 4, 24, 48 hours and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)
Population: The safety population included all participants who received ioflupane (123I) injection. Here, number analyzed signifies participants who were evaluable for given categories at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Vital Sign-Respiratory Rate at Pre-specified Timepoints | At Baseline | 18.4 breaths/min | Standard Deviation 1.19 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Vital Sign-Respiratory Rate at Pre-specified Timepoints | Change at 10 minutes | -0.9 breaths/min | Standard Deviation 1.73 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Vital Sign-Respiratory Rate at Pre-specified Timepoints | Change at 20 minutes | -1.0 breaths/min | Standard Deviation 1.15 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Vital Sign-Respiratory Rate at Pre-specified Timepoints | Change at 30 minutes | -1.4 breaths/min | Standard Deviation 1.92 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Vital Sign-Respiratory Rate at Pre-specified Timepoints | Change at 1 hour | -1.1 breaths/min | Standard Deviation 1.64 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Vital Sign-Respiratory Rate at Pre-specified Timepoints | Change at 2 hours | -0.8 breaths/min | Standard Deviation 1.39 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Vital Sign-Respiratory Rate at Pre-specified Timepoints | Change at 4 hours | -0.3 breaths/min | Standard Deviation 1.83 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Vital Sign-Respiratory Rate at Pre-specified Timepoints | Change at 24 hours | -0.8 breaths/min | Standard Deviation 1.58 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Vital Sign-Respiratory Rate at Pre-specified Timepoints | Change at 48 hours | -0.9 breaths/min | Standard Deviation 0.99 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Vital Sign-Respiratory Rate at Pre-specified Timepoints | Change at 2 weeks | -0.4 breaths/min | Standard Deviation 1.92 |
Primary
Change From Baseline in Vital Sign-Systolic Blood Pressure at Pre-specified Timepoints
Change from baseline in systolic blood pressure were reported.
Time frame: Baseline, 10, 20, 30 minutes and 1, 2, 4, 24, 48 hours and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)
Population: The safety population included all participants who received ioflupane (123I) injection. Here, number analyzed signifies participants who were evaluable at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Vital Sign-Systolic Blood Pressure at Pre-specified Timepoints | At Baseline | 109.6 millimeters of mercury (mmHg) | Standard Deviation 12.43 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Vital Sign-Systolic Blood Pressure at Pre-specified Timepoints | Change at 10 minutes | -3.4 millimeters of mercury (mmHg) | Standard Deviation 6.41 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Vital Sign-Systolic Blood Pressure at Pre-specified Timepoints | Change at 20 minutes | -5.0 millimeters of mercury (mmHg) | Standard Deviation 5.69 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Vital Sign-Systolic Blood Pressure at Pre-specified Timepoints | Change at 30 minutes | -5.8 millimeters of mercury (mmHg) | Standard Deviation 4.8 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Vital Sign-Systolic Blood Pressure at Pre-specified Timepoints | Change at 1 hour | 1.0 millimeters of mercury (mmHg) | Standard Deviation 4.75 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Vital Sign-Systolic Blood Pressure at Pre-specified Timepoints | Change at 2 hours | -1.1 millimeters of mercury (mmHg) | Standard Deviation 7.9 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Vital Sign-Systolic Blood Pressure at Pre-specified Timepoints | Change at 4 hours | -5.0 millimeters of mercury (mmHg) | Standard Deviation 7.65 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Vital Sign-Systolic Blood Pressure at Pre-specified Timepoints | Change at 24 hours | -2.3 millimeters of mercury (mmHg) | Standard Deviation 3.65 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Vital Sign-Systolic Blood Pressure at Pre-specified Timepoints | Change at 48 hours | -1.6 millimeters of mercury (mmHg) | Standard Deviation 4.63 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Vital Sign-Systolic Blood Pressure at Pre-specified Timepoints | Change at 2 weeks | -2.3 millimeters of mercury (mmHg) | Standard Deviation 8.68 |
Primary
Change From Baseline in Vital Sign-Temperature at Pre-specified Timepoints
Change from baseline in temperature were reported.
Time frame: Baseline, 10, 20, 30 minutes and 1, 2, 4, 24, 48 hours and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)
Population: The safety population included all participants who received ioflupane (123I) injection. Here, number analyzed signifies participants who were evaluable at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Vital Sign-Temperature at Pre-specified Timepoints | At Baseline | 36.45 degrees celsius (°C) | Standard Deviation 0.239 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Vital Sign-Temperature at Pre-specified Timepoints | Change at 10 minutes | 0.14 degrees celsius (°C) | Standard Deviation 0.35 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Vital Sign-Temperature at Pre-specified Timepoints | Change at 20 minutes | 0.13 degrees celsius (°C) | Standard Deviation 0.519 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Vital Sign-Temperature at Pre-specified Timepoints | Change at 30 minutes | 0.13 degrees celsius (°C) | Standard Deviation 0.301 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Vital Sign-Temperature at Pre-specified Timepoints | Change at 1 hour | 0.13 degrees celsius (°C) | Standard Deviation 0.255 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Vital Sign-Temperature at Pre-specified Timepoints | Change at 2 hours | 0.10 degrees celsius (°C) | Standard Deviation 0.273 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Vital Sign-Temperature at Pre-specified Timepoints | Change at 4 hours | 0.13 degrees celsius (°C) | Standard Deviation 0.377 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Vital Sign-Temperature at Pre-specified Timepoints | Change at 24 hours | -0.04 degrees celsius (°C) | Standard Deviation 0.389 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Vital Sign-Temperature at Pre-specified Timepoints | Change at 48 hours | 0.14 degrees celsius (°C) | Standard Deviation 0.316 |
| DaTSCAN™ Ioflupane (123I) Injection | Change From Baseline in Vital Sign-Temperature at Pre-specified Timepoints | Change at 2 weeks | 0.11 degrees celsius (°C) | Standard Deviation 0.29 |
Primary
Number of Participants Who Reported Abnormal Injection Site Monitoring Findings at Pre-specified Timepoints
Any radiopharmaceutical extravasation, bleeding, hematoma, redness, infection, or other findings were considered as abnormal findings.
Time frame: Baseline, up to 4 hours after DaTSCAN™ ioflupane (123I) injection
Population: The safety population included all participants who received ioflupane (123I) injection.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DaTSCAN™ Ioflupane (123I) Injection | Number of Participants Who Reported Abnormal Injection Site Monitoring Findings at Pre-specified Timepoints | 0 Participants |
Primary
Number of Participants With Adverse Events (AEs)
An AE was defined as any untoward medical occurrence in participants or clinical investigation participant which did not necessarily have to have been related to the investigational medical product (IMP). AEs were recorded from time of informed consent through the follow-up visit at 2 weeks (±2 days) after IMP administration.
Time frame: Baseline up to 2 weeks after IMP administration (i.e., up to 16 days)
Population: The safety population included all participants who received ioflupane (123I) injection.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DaTSCAN™ Ioflupane (123I) Injection | Number of Participants With Adverse Events (AEs) | 7 Participants |
Primary
Number of Participants With Clinically Significant Abnormal Urinalysis Parameters - pH and Specific Gravity at Pre-specified Timepoints
Number of participants with clinically significant abnormal pH and specific gravity were reported. Clinical significance was determined by investigator.
Time frame: Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)
Population: The safety population included all participants who received ioflupane (123I) injection.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DaTSCAN™ Ioflupane (123I) Injection | Number of Participants With Clinically Significant Abnormal Urinalysis Parameters - pH and Specific Gravity at Pre-specified Timepoints | pH: At Baseline | 0 Participants |
| DaTSCAN™ Ioflupane (123I) Injection | Number of Participants With Clinically Significant Abnormal Urinalysis Parameters - pH and Specific Gravity at Pre-specified Timepoints | pH: At 3 Hours | 0 Participants |
| DaTSCAN™ Ioflupane (123I) Injection | Number of Participants With Clinically Significant Abnormal Urinalysis Parameters - pH and Specific Gravity at Pre-specified Timepoints | pH: At 48 Hours | 0 Participants |
| DaTSCAN™ Ioflupane (123I) Injection | Number of Participants With Clinically Significant Abnormal Urinalysis Parameters - pH and Specific Gravity at Pre-specified Timepoints | pH: At 2 Weeks | 0 Participants |
| DaTSCAN™ Ioflupane (123I) Injection | Number of Participants With Clinically Significant Abnormal Urinalysis Parameters - pH and Specific Gravity at Pre-specified Timepoints | Specific gravity: At Baseline | 0 Participants |
| DaTSCAN™ Ioflupane (123I) Injection | Number of Participants With Clinically Significant Abnormal Urinalysis Parameters - pH and Specific Gravity at Pre-specified Timepoints | Specific gravity: At 3 Hours | 0 Participants |
| DaTSCAN™ Ioflupane (123I) Injection | Number of Participants With Clinically Significant Abnormal Urinalysis Parameters - pH and Specific Gravity at Pre-specified Timepoints | Specific gravity: At 48 Hours | 0 Participants |
| DaTSCAN™ Ioflupane (123I) Injection | Number of Participants With Clinically Significant Abnormal Urinalysis Parameters - pH and Specific Gravity at Pre-specified Timepoints | Specific gravity: At 2 Weeks | 0 Participants |
Primary
Number of Participants With Clinically Significant Change From Baseline in Physical Examination Findings Pre-specified Timepoints
Physical examination included recording an assessment for the presence of abnormalities of the following: general appearance, skin, lungs, cardiovascular system, back and spine, abdomen, extremities, lymph nodes, and neurological exam. Clinical significance was determined by investigator.
Time frame: Baseline, 4 hours after injection and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)
Population: The safety population included all participants who received ioflupane (123I) injection.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DaTSCAN™ Ioflupane (123I) Injection | Number of Participants With Clinically Significant Change From Baseline in Physical Examination Findings Pre-specified Timepoints | At Baseline | 0 Participants |
| DaTSCAN™ Ioflupane (123I) Injection | Number of Participants With Clinically Significant Change From Baseline in Physical Examination Findings Pre-specified Timepoints | At 4 hours | 0 Participants |
| DaTSCAN™ Ioflupane (123I) Injection | Number of Participants With Clinically Significant Change From Baseline in Physical Examination Findings Pre-specified Timepoints | At 2 weeks | 0 Participants |
Secondary
Biodistribution as Measured by Decay-corrected Cumulative 123I Activity Concentration in Excreted Urine
Excretion of 123I following the IV administration of ioflupane (123I) Injection was determined by measuring the 123I activity within the intestinal contents and the sum of the 123I activities in the voided urine up to 48 hours post-injection.
Time frame: 10 minutes and 1, 2, 3, 4, 5, 5 to 24, and 24 to 48 hours after DaTSCAN™ ioflupane (123I) injection
Population: PK population included all participants who received ioflupane (123I) injection, underwent planar scintigraphy, and had \>=1 set of images and \>=1 blood sampling at prespecified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution as Measured by Decay-corrected Cumulative 123I Activity Concentration in Excreted Urine | 10 min | 0.00 %IA (per hour) | Standard Deviation 0 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution as Measured by Decay-corrected Cumulative 123I Activity Concentration in Excreted Urine | 1 hour | 0.83 %IA (per hour) | Standard Deviation 0.82 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution as Measured by Decay-corrected Cumulative 123I Activity Concentration in Excreted Urine | 2 hour | 2.76 %IA (per hour) | Standard Deviation 1.96 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution as Measured by Decay-corrected Cumulative 123I Activity Concentration in Excreted Urine | 3 hour | 4.97 %IA (per hour) | Standard Deviation 1.33 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution as Measured by Decay-corrected Cumulative 123I Activity Concentration in Excreted Urine | 4 hour | 6.28 %IA (per hour) | Standard Deviation 1.52 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution as Measured by Decay-corrected Cumulative 123I Activity Concentration in Excreted Urine | 5 hour | 8.37 %IA (per hour) | Standard Deviation 1.73 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution as Measured by Decay-corrected Cumulative 123I Activity Concentration in Excreted Urine | 5 to 24 hour | 30.15 %IA (per hour) | Standard Deviation 3.77 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution as Measured by Decay-corrected Cumulative 123I Activity Concentration in Excreted Urine | 24 to 48 hour | 45.45 %IA (per hour) | Standard Deviation 8.73 |
Secondary
Biodistribution by Source Regions Measured by Decay Corrected Normalized Cumulative Activity
Biodistribution measured by decay corrected normalized cumulative activity in bladder content, brain, gallbladder, liver, lower large intestine, lungs, remainder, small intestine, upper large intestine was reported.
Time frame: Up to 48 hours after DaTSCAN™ ioflupane (123I) injection
Population: PK population included all participants who received ioflupane (123I) injection, underwent planar scintigraphy, and had \>=1 set of images and \>=1 blood sampling at prespecified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution by Source Regions Measured by Decay Corrected Normalized Cumulative Activity | Bladder Content | 0.5480 becquerel·hour/ becquerel (MBq·h / MBq) | Standard Deviation 0.07681 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution by Source Regions Measured by Decay Corrected Normalized Cumulative Activity | Brain | 0.6598 becquerel·hour/ becquerel (MBq·h / MBq) | Standard Deviation 0.15464 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution by Source Regions Measured by Decay Corrected Normalized Cumulative Activity | Gallbladder | 0.0466 becquerel·hour/ becquerel (MBq·h / MBq) | Standard Deviation 0.01877 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution by Source Regions Measured by Decay Corrected Normalized Cumulative Activity | Liver | 1.2551 becquerel·hour/ becquerel (MBq·h / MBq) | Standard Deviation 0.46846 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution by Source Regions Measured by Decay Corrected Normalized Cumulative Activity | Lower Large Intestine | 0.4605 becquerel·hour/ becquerel (MBq·h / MBq) | Standard Deviation 0.16382 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution by Source Regions Measured by Decay Corrected Normalized Cumulative Activity | Lungs | 1.664 becquerel·hour/ becquerel (MBq·h / MBq) | Standard Deviation 0.2683 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution by Source Regions Measured by Decay Corrected Normalized Cumulative Activity | Remainder | 9.409 becquerel·hour/ becquerel (MBq·h / MBq) | Standard Deviation 1.042 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution by Source Regions Measured by Decay Corrected Normalized Cumulative Activity | Small Intestine | 0.2904 becquerel·hour/ becquerel (MBq·h / MBq) | Standard Deviation 0.10342 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution by Source Regions Measured by Decay Corrected Normalized Cumulative Activity | Upper Large Intestine | 0.5620 becquerel·hour/ becquerel (MBq·h / MBq) | Standard Deviation 0.19993 |
Secondary
Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Blood (Plasma and Whole Blood)
The decay-corrected %IA was measured by planar scintigraphy. The biodistribution as measured by the decay-corrected %IA in the plasma and whole blood at specified timepoints were reported.
Time frame: Pre-dose, 5, 15, 30 minutes and 1, 2, 3, 4, 5, 24, and 48 hours after DaTSCAN™ ioflupane (123I) injection
Population: Pharmacokinetic (PK) population included all participants who received ioflupane (123I) injection, underwent planar scintigraphy, and had greater than or equal to (\>=) 1 set of images and \>=1 blood sampling at prespecified time points. Here, number analyzed signifies participants who were evaluable for given categories at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Blood (Plasma and Whole Blood) | Plasma: Pre-dose | 0.016 %IA | Standard Deviation 0.0074 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Blood (Plasma and Whole Blood) | Plasma: 5 minutes | 2.769 %IA | Standard Deviation 0.7735 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Blood (Plasma and Whole Blood) | Plasma: 15 minutes | 1.686 %IA | Standard Deviation 0.5573 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Blood (Plasma and Whole Blood) | Plasma: 30 minutes | 1.350 %IA | Standard Deviation 0.2935 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Blood (Plasma and Whole Blood) | Plasma: 1 hour | 1.351 %IA | Standard Deviation 0.2671 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Blood (Plasma and Whole Blood) | Plasma: 2 hours | 1.375 %IA | Standard Deviation 0.3407 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Blood (Plasma and Whole Blood) | Plasma: 3 hours | 1.338 %IA | Standard Deviation 0.3851 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Blood (Plasma and Whole Blood) | Plasma: 4 hours | 1.229 %IA | Standard Deviation 0.336 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Blood (Plasma and Whole Blood) | Plasma: 5 hours | 1.138 %IA | Standard Deviation 0.3006 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Blood (Plasma and Whole Blood) | Plasma: 24 hours | 0.768 %IA | Standard Deviation 0.1817 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Blood (Plasma and Whole Blood) | Plasma: 48 hours | 0.626 %IA | Standard Deviation 0.1382 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Blood (Plasma and Whole Blood) | Whole Blood: Pre-dose | 0.030 %IA | Standard Deviation 0.0093 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Blood (Plasma and Whole Blood) | Whole Blood: 5 minutes | 4.564 %IA | Standard Deviation 1.471 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Blood (Plasma and Whole Blood) | Whole Blood: 15 minutes | 2.798 %IA | Standard Deviation 0.9416 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Blood (Plasma and Whole Blood) | Whole Blood: 30 minutes | 2.220 %IA | Standard Deviation 0.5049 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Blood (Plasma and Whole Blood) | Whole Blood: 1 hour | 2.220 %IA | Standard Deviation 0.4721 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Blood (Plasma and Whole Blood) | Whole Blood: 2 hours | 2.355 %IA | Standard Deviation 0.5505 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Blood (Plasma and Whole Blood) | Whole Blood: 3 hours | 2.216 %IA | Standard Deviation 0.5506 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Blood (Plasma and Whole Blood) | Whole Blood: 4 hours | 2.081 %IA | Standard Deviation 0.4923 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Blood (Plasma and Whole Blood) | Whole Blood: 5 hours | 1.924 %IA | Standard Deviation 0.4038 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Blood (Plasma and Whole Blood) | Whole Blood: 24 hours | 1.348 %IA | Standard Deviation 0.3392 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Blood (Plasma and Whole Blood) | Whole Blood: 48 hours | 1.098 %IA | Standard Deviation 0.3441 |
Secondary
Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image
The decay-corrected %IA was measured by planar scintigraphy. The biodistribution as measured by the decay-corrected %IA in the whole-body image which included background, heart, intestines, liver, lungs, salivary glands, stomach, striatum, thyroid, whole body, whole brain) at specified timepoints were reported.
Time frame: 10 minutes and 1, 2, 4, 5, 24, and 48 hours after DaTSCAN™ ioflupane (123I) injection
Population: PK population included all participants who received ioflupane (123I) injection, underwent planar scintigraphy, and had \>=1 set of images and \>=1 blood sampling at prespecified time points. Here, number analyzed signifies participants who were evaluable for given categories at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image | Background: 10 minutes | 0.63 %IA | Standard Deviation 0.149 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image | Background: 1 hour | 0.59 %IA | Standard Deviation 0.181 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image | Background: 2 hour | 0.59 %IA | Standard Deviation 0.164 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image | Background: 4 hour | 0.64 %IA | Standard Deviation 0.151 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image | Background: 5 hour | 0.60 %IA | Standard Deviation 0.153 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image | Background: 24 hour | 0.45 %IA | Standard Deviation 0.12 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image | Background: 48 hour | 0.33 %IA | Standard Deviation 0.104 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image | Heart: 10 minutes | 1.28 %IA | Standard Deviation 0.427 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image | Heart: 1 hour | 1.09 %IA | Standard Deviation 0.323 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image | Heart: 2 hour | 1.09 %IA | Standard Deviation 0.259 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image | Heart: 4 hour | 0.83 %IA | Standard Deviation 0.189 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image | Heart: 5 hour | 0.83 %IA | Standard Deviation 0.214 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image | Heart: 24 hour | 0.54 %IA | Standard Deviation 0.245 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image | Heart: 48 hour | 0.35 %IA | Standard Deviation 0.107 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image | Intestines: 10 minutes | 6.30 %IA | Standard Deviation 2.821 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image | Intestines: 1 hour | 7.69 %IA | Standard Deviation 2.569 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image | Intestines: 2 hour | 8.95 %IA | Standard Deviation 3.254 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image | Intestines: 4 hour | 8.27 %IA | Standard Deviation 3.355 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image | Intestines: 5 hour | 8.91 %IA | Standard Deviation 3.55 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image | Intestines: 24 hour | 7.25 %IA | Standard Deviation 3.013 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image | Intestines: 48 hour | 5.29 %IA | Standard Deviation 2.523 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image | Liver: 10 minutes | 14.14 %IA | Standard Deviation 2.392 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image | Liver: 1 hour | 14.31 %IA | Standard Deviation 3.419 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image | Liver: 2 hour | 12.08 %IA | Standard Deviation 3.066 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image | Liver: 4 hour | 7.84 %IA | Standard Deviation 0.914 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image | Liver: 5 hour | 7.21 %IA | Standard Deviation 0.975 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image | Liver: 24 hour | 4.80 %IA | Standard Deviation 1.611 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image | Liver: 48 hour | 3.13 %IA | Standard Deviation 0.772 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image | Lungs: 10 minutes | 12.65 %IA | Standard Deviation 1.977 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image | Lungs: 1 hour | 11.80 %IA | Standard Deviation 1.788 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image | Lungs: 2 hour | 11.59 %IA | Standard Deviation 1.705 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image | Lungs: 4 hour | 10.61 %IA | Standard Deviation 1.152 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image | Lungs: 5 hour | 10.20 %IA | Standard Deviation 1.425 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image | Lungs: 24 hour | 7.36 %IA | Standard Deviation 1.682 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image | Lungs: 48 hour | 5.04 %IA | Standard Deviation 1.44 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image | Salivary Glands: 10 minutes | 0.05 %IA | Standard Deviation 0.053 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image | Salivary Glands: 1 hour | 0.03 %IA | Standard Deviation 0.046 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image | Salivary Glands: 2 hour | 0.05 %IA | Standard Deviation 0.053 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image | Salivary Glands: 4 hour | 0.04 %IA | Standard Deviation 0.053 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image | Salivary Glands: 5 hour | 0.06 %IA | Standard Deviation 0.053 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image | Salivary Glands: 24 hour | 0.03 %IA | Standard Deviation 0.046 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image | Salivary Glands: 48 hour | 0.01 %IA | Standard Deviation 0.035 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image | Spleen: 10 minutes | 0.75 %IA | Standard Deviation 0.33 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image | Spleen: 1 hour | 0.65 %IA | Standard Deviation 0.239 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image | Spleen: 2 hour | 0.64 %IA | Standard Deviation 0.185 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image | Spleen: 4 hour | 0.41 %IA | Standard Deviation 0.168 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image | Spleen: 5 hour | 0.43 %IA | Standard Deviation 0.18 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image | Spleen: 24 hour | 0.26 %IA | Standard Deviation 0.074 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image | Spleen: 48 hour | 0.16 %IA | Standard Deviation 0.092 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image | Stomach: 10 minutes | 1.74 %IA | Standard Deviation 0.684 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image | Stomach: 1 hour | 1.53 %IA | Standard Deviation 0.557 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image | Stomach: 2 hour | 1.34 %IA | Standard Deviation 0.45 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image | Stomach: 4 hour | 0.76 %IA | Standard Deviation 0.244 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image | Stomach: 5 hour | 0.81 %IA | Standard Deviation 0.204 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image | Stomach: 24 hour | 0.63 %IA | Standard Deviation 0.315 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image | Stomach: 48 hour | 0.44 %IA | Standard Deviation 0.13 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image | Striatum: 10 minutes | 1.30 %IA | Standard Deviation 0.293 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image | Striatum: 1 hour | 1.08 %IA | Standard Deviation 0.249 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image | Striatum: 2 hour | 0.99 %IA | Standard Deviation 0.259 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image | Striatum: 4 hour | 0.90 %IA | Standard Deviation 0.216 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image | Striatum: 5 hour | 0.87 %IA | Standard Deviation 0.229 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image | Striatum: 24 hour | 0.58 %IA | Standard Deviation 0.167 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image | Striatum: 48 hour | 0.39 %IA | Standard Deviation 0.099 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image | Thyroid: 10 minutes | 0.09 %IA | Standard Deviation 0.064 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image | Thyroid: 1 hour | 0.08 %IA | Standard Deviation 0.071 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image | Thyroid: 2 hour | 0.08 %IA | Standard Deviation 0.046 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image | Thyroid: 4 hour | 0.07 %IA | Standard Deviation 0.049 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image | Thyroid: 5 hour | 0.06 %IA | Standard Deviation 0.053 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image | Thyroid: 24 hour | 0.00 %IA | Standard Deviation 0 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image | Thyroid: 48 hour | 0.01 %IA | Standard Deviation 0.035 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image | Whole body: 10 minutes | 104.09 %IA | Standard Deviation 13.451 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image | Whole body: 1 hour | 104.63 %IA | Standard Deviation 14.962 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image | Whole body: 2 hour | 103.41 %IA | Standard Deviation 12.974 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image | Whole body: 4 hour | 96.04 %IA | Standard Deviation 10.938 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image | Whole body: 5 hour | 94.53 %IA | Standard Deviation 10.859 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image | Whole body: 24 hour | 75.96 %IA | Standard Deviation 10.908 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image | Whole body: 48 hour | 59.48 %IA | Standard Deviation 10.573 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image | Whole Brain: 10 minutes | 6.54 %IA | Standard Deviation 1.537 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image | Whole Brain: 1 hour | 4.96 %IA | Standard Deviation 1.302 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image | Whole Brain: 2 hour | 4.60 %IA | Standard Deviation 1.164 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image | Whole Brain: 4 hour | 4.26 %IA | Standard Deviation 1.013 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image | Whole Brain: 5 hour | 4.10 %IA | Standard Deviation 0.97 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image | Whole Brain: 24 hour | 2.79 %IA | Standard Deviation 0.651 |
| DaTSCAN™ Ioflupane (123I) Injection | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image | Whole Brain: 48 hour | 2.08 %IA | Standard Deviation 0.437 |
Secondary
Effective Dose (ED) of Ioflupane (123I) Injection After IV Administration
The ED per unit of administered activity was evaluated from the ensemble of absorbed dose data.
Time frame: Up to 48 hours after DaTSCAN™ ioflupane (123I) injection
Population: PK population included all participants who received ioflupane (123I) injection, underwent planar scintigraphy, and had \>=1 set of images and \>=1 blood sampling at prespecified time points.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DaTSCAN™ Ioflupane (123I) Injection | Effective Dose (ED) of Ioflupane (123I) Injection After IV Administration | 0.0280 millisievert/becquerel (mSv/MBq) | Standard Deviation 0.00448 |
Secondary
Normalized Organ Absorbed Doses as Measured by Radiation Dosimetry
Sex-averaged normalized organ absorbed doses calculated according to Medical Internal Radiation Dose (MIRD) method.
Time frame: Up to 48 hours after DaTSCAN™ ioflupane (123I) injection
Population: PK population included all participants who received ioflupane (123I) injection, underwent planar scintigraphy, and had \>=1 set of images and \>=1 blood sampling at prespecified time points. Testes in category were assessed for male participants only. Here, number analyzed signifies participants who were evaluable for given categories.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DaTSCAN™ Ioflupane (123I) Injection | Normalized Organ Absorbed Doses as Measured by Radiation Dosimetry | Total Body | 0.0136 milligray/becquerel (mGy/MBq) | Standard Deviation 0.00162 |
| DaTSCAN™ Ioflupane (123I) Injection | Normalized Organ Absorbed Doses as Measured by Radiation Dosimetry | Adrenals | 0.0157 milligray/becquerel (mGy/MBq) | Standard Deviation 0.00161 |
| DaTSCAN™ Ioflupane (123I) Injection | Normalized Organ Absorbed Doses as Measured by Radiation Dosimetry | Brain | 0.0217 milligray/becquerel (mGy/MBq) | Standard Deviation 0.00573 |
| DaTSCAN™ Ioflupane (123I) Injection | Normalized Organ Absorbed Doses as Measured by Radiation Dosimetry | Breasts | 0.0092 milligray/becquerel (mGy/MBq) | Standard Deviation 0.00098 |
| DaTSCAN™ Ioflupane (123I) Injection | Normalized Organ Absorbed Doses as Measured by Radiation Dosimetry | Gallbladder Wall | 0.0301 milligray/becquerel (mGy/MBq) | Standard Deviation 0.0054 |
| DaTSCAN™ Ioflupane (123I) Injection | Normalized Organ Absorbed Doses as Measured by Radiation Dosimetry | Heart Wall | 0.0240 milligray/becquerel (mGy/MBq) | Standard Deviation 0.00478 |
| DaTSCAN™ Ioflupane (123I) Injection | Normalized Organ Absorbed Doses as Measured by Radiation Dosimetry | Kidneys | 0.0132 milligray/becquerel (mGy/MBq) | Standard Deviation 0.0015 |
| DaTSCAN™ Ioflupane (123I) Injection | Normalized Organ Absorbed Doses as Measured by Radiation Dosimetry | Liver | 0.0351 milligray/becquerel (mGy/MBq) | Standard Deviation 0.00838 |
| DaTSCAN™ Ioflupane (123I) Injection | Normalized Organ Absorbed Doses as Measured by Radiation Dosimetry | Lower Large Intestine Wall | 0.0526 milligray/becquerel (mGy/MBq) | Standard Deviation 0.01653 |
| DaTSCAN™ Ioflupane (123I) Injection | Normalized Organ Absorbed Doses as Measured by Radiation Dosimetry | Lungs | 0.0523 milligray/becquerel (mGy/MBq) | Standard Deviation 0.00706 |
| DaTSCAN™ Ioflupane (123I) Injection | Normalized Organ Absorbed Doses as Measured by Radiation Dosimetry | Muscle | 0.0111 milligray/becquerel (mGy/MBq) | Standard Deviation 0.00138 |
| DaTSCAN™ Ioflupane (123I) Injection | Normalized Organ Absorbed Doses as Measured by Radiation Dosimetry | Osteogenic Cells | 0.0331 milligray/becquerel (mGy/MBq) | Standard Deviation 0.00504 |
| DaTSCAN™ Ioflupane (123I) Injection | Normalized Organ Absorbed Doses as Measured by Radiation Dosimetry | Ovaries | 0.0205 milligray/becquerel (mGy/MBq) | Standard Deviation 0.00451 |
| DaTSCAN™ Ioflupane (123I) Injection | Normalized Organ Absorbed Doses as Measured by Radiation Dosimetry | Pancreas | 0.0167 milligray/becquerel (mGy/MBq) | Standard Deviation 0.00194 |
| DaTSCAN™ Ioflupane (123I) Injection | Normalized Organ Absorbed Doses as Measured by Radiation Dosimetry | Red Marrow | 0.0108 milligray/becquerel (mGy/MBq) | Standard Deviation 0.00129 |
| DaTSCAN™ Ioflupane (123I) Injection | Normalized Organ Absorbed Doses as Measured by Radiation Dosimetry | Skin | 0.0069 milligray/becquerel (mGy/MBq) | Standard Deviation 0.00086 |
| DaTSCAN™ Ioflupane (123I) Injection | Normalized Organ Absorbed Doses as Measured by Radiation Dosimetry | Small Intestine | 0.0263 milligray/becquerel (mGy/MBq) | Standard Deviation 0.00675 |
| DaTSCAN™ Ioflupane (123I) Injection | Normalized Organ Absorbed Doses as Measured by Radiation Dosimetry | Spleen | 0.0183 milligray/becquerel (mGy/MBq) | Standard Deviation 0.0055 |
| DaTSCAN™ Ioflupane (123I) Injection | Normalized Organ Absorbed Doses as Measured by Radiation Dosimetry | Stomach Wall | 0.0216 milligray/becquerel (mGy/MBq) | Standard Deviation 0.00439 |
| DaTSCAN™ Ioflupane (123I) Injection | Normalized Organ Absorbed Doses as Measured by Radiation Dosimetry | Testes | 0.0086 milligray/becquerel (mGy/MBq) | Standard Deviation 0.00091 |
| DaTSCAN™ Ioflupane (123I) Injection | Normalized Organ Absorbed Doses as Measured by Radiation Dosimetry | Thymus | 0.0123 milligray/becquerel (mGy/MBq) | Standard Deviation 0.00149 |
| DaTSCAN™ Ioflupane (123I) Injection | Normalized Organ Absorbed Doses as Measured by Radiation Dosimetry | Thyroid | 0.0166 milligray/becquerel (mGy/MBq) | Standard Deviation 0.00471 |
| DaTSCAN™ Ioflupane (123I) Injection | Normalized Organ Absorbed Doses as Measured by Radiation Dosimetry | Upper Large Intestine Wall | 0.0480 milligray/becquerel (mGy/MBq) | Standard Deviation 0.01548 |
| DaTSCAN™ Ioflupane (123I) Injection | Normalized Organ Absorbed Doses as Measured by Radiation Dosimetry | Urinary Bladder Wall | 0.0602 milligray/becquerel (mGy/MBq) | Standard Deviation 0.01423 |
| DaTSCAN™ Ioflupane (123I) Injection | Normalized Organ Absorbed Doses as Measured by Radiation Dosimetry | Uterus | 0.0184 milligray/becquerel (mGy/MBq) | Standard Deviation 0.00281 |