Trial Outcomes & Findings for A Study to Evaluate the Safety, Biodistribution, Internal Radiation Dosimetry, and Effective Dose of DaTSCAN™ Ioflupane (123I) Injection in Chinese Healthy Volunteers. (NCT NCT04564092)
NCT ID: NCT04564092
Last Updated: 2023-08-02
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
9 participants
Primary outcome timeframe
Baseline up to 2 weeks after IMP administration (i.e., up to 16 days)
Results posted on
2023-08-02
Participant Flow
Participant milestones
| Measure |
DaTSCAN™ Ioflupane (123I) Injection
Participants received a single administration of DaTSCAN™ ioflupane (123I) injection by bolus intravenous (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 single photon emission computed tomography (SPECT) imaging was performed at 3 and 6 hours after administration.
|
|---|---|
|
Overall Study
STARTED
|
9
|
|
Overall Study
Safety Population
|
8
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
DaTSCAN™ Ioflupane (123I) Injection
Participants received a single administration of DaTSCAN™ ioflupane (123I) injection by bolus intravenous (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 single photon emission computed tomography (SPECT) imaging was performed at 3 and 6 hours after administration.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
A Study to Evaluate the Safety, Biodistribution, Internal Radiation Dosimetry, and Effective Dose of DaTSCAN™ Ioflupane (123I) Injection in Chinese Healthy Volunteers.
Baseline characteristics by cohort
| Measure |
DaTSCAN™ Ioflupane (123I) Injection
n=8 Participants
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.
|
|---|---|
|
Age, Continuous
|
31.1 years
STANDARD_DEVIATION 7.34 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Chinese
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Mixed race or non-Chinese
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Han Chinese
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Other
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
8 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
DaTSCAN™ Ioflupane (123I) Injection
n=8 Participants
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.
|
|---|---|
|
Number of Participants With Adverse Events (AEs)
|
7 Participants
|
PRIMARY outcome
Timeframe: 1 hour before injection (baseline), and at approximately 15 minutes, 1, 4, 24, 48 hours after DaTSCAN™ ioflupane (123I) injectionPopulation: 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.
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.
Outcome measures
| Measure |
DaTSCAN™ Ioflupane (123I) Injection
n=8 Participants
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.
|
|---|---|
|
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 0.00
|
|
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
|
|
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
|
|
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
|
|
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 0.00
|
|
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 0.00
|
|
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 0.00
|
|
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 0.00
|
|
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 0.00
|
|
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 0.00
|
|
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 0.00
|
|
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 0.00
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
DaTSCAN™ Ioflupane (123I) Injection
n=8 Participants
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.
|
|---|---|
|
Number of Participants With Clinically Significant Change From Baseline in Physical Examination Findings Pre-specified Timepoints
At Baseline
|
0 Participants
|
|
Number of Participants With Clinically Significant Change From Baseline in Physical Examination Findings Pre-specified Timepoints
At 4 hours
|
0 Participants
|
|
Number of Participants With Clinically Significant Change From Baseline in Physical Examination Findings Pre-specified Timepoints
At 2 weeks
|
0 Participants
|
PRIMARY outcome
Timeframe: 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.
Change from baseline in activated partial thromboplastin time, prothrombin time, thrombin time were reported.
Outcome measures
| Measure |
DaTSCAN™ Ioflupane (123I) Injection
n=8 Participants
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.
|
|---|---|
|
Change From Baseline in Hematology Parameters at Pre-specified Timepoints
Activated Partial Thromboplastin Time: At Baseline
|
29.68 seconds
Standard Deviation 2.241
|
|
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
|
|
Change From Baseline in Hematology Parameters at Pre-specified Timepoints
Activated Partial Thromboplastin Time: Change at 48 Hours
|
0.06 seconds
Standard Deviation 2.410
|
|
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
|
|
Change From Baseline in Hematology Parameters at Pre-specified Timepoints
Prothrombin Time: At Baseline
|
11.75 seconds
Standard Deviation 0.472
|
|
Change From Baseline in Hematology Parameters at Pre-specified Timepoints
Prothrombin Time: Change at 3 Hours
|
-0.16 seconds
Standard Deviation 0.715
|
|
Change From Baseline in Hematology Parameters at Pre-specified Timepoints
Prothrombin Time: Change at 48 Hours
|
0.06 seconds
Standard Deviation 0.370
|
|
Change From Baseline in Hematology Parameters at Pre-specified Timepoints
Prothrombin Time: Change at 2 weeks
|
0.28 seconds
Standard Deviation 0.365
|
|
Change From Baseline in Hematology Parameters at Pre-specified Timepoints
Thrombin Time: At Baseline
|
18.48 seconds
Standard Deviation 1.229
|
|
Change From Baseline in Hematology Parameters at Pre-specified Timepoints
Thrombin Time: Change at 3 Hours
|
-0.08 seconds
Standard Deviation 1.753
|
|
Change From Baseline in Hematology Parameters at Pre-specified Timepoints
Thrombin Time: Change at 48 Hours
|
-0.08 seconds
Standard Deviation 1.567
|
|
Change From Baseline in Hematology Parameters at Pre-specified Timepoints
Thrombin Time: Change at 2 weeks
|
0.06 seconds
Standard Deviation 1.530
|
PRIMARY outcome
Timeframe: 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.
Change from baseline in C reactive protein were reported.
Outcome measures
| Measure |
DaTSCAN™ Ioflupane (123I) Injection
n=8 Participants
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.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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 outcome
Timeframe: 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.
Change from baseline in hematocrit were reported.
Outcome measures
| Measure |
DaTSCAN™ Ioflupane (123I) Injection
n=8 Participants
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.
|
|---|---|
|
Change From Baseline in Hematology Parameter-Hematocrit at Pre-specified Timepoints
At Baseline
|
0.4184 percent of red blood cells
Standard Deviation 0.03175
|
|
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
|
|
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
|
|
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 outcome
Timeframe: 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.
Change from baseline in erythrocytes were reported.
Outcome measures
| Measure |
DaTSCAN™ Ioflupane (123I) Injection
n=8 Participants
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.
|
|---|---|
|
Change From Baseline in Hematology Parameter-Erythrocytes at Pre-specified Timepoints
At Baseline
|
4.711 10^12 cells per liter
Standard Deviation 0.5148
|
|
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
|
|
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
|
|
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 outcome
Timeframe: 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).
Change from baseline in leukocytes, platelets timepoints were reported.
Outcome measures
| Measure |
DaTSCAN™ Ioflupane (123I) Injection
n=8 Participants
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.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 30.40
|
|
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 outcome
Timeframe: 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.
Change from baseline in fibrinogen, hemoglobin were reported.
Outcome measures
| Measure |
DaTSCAN™ Ioflupane (123I) Injection
n=8 Participants
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.
|
|---|---|
|
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 0.480
|
|
Change From Baseline in Hematology Parameters- Fibrinogen, Hemoglobin at Pre-specified Timepoints
Fibrinogen: At Baseline
|
2.61 grams per liter (g/L)
Standard Deviation 0.470
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 outcome
Timeframe: 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.
Change from baseline in albumin, protein were reported.
Outcome measures
| Measure |
DaTSCAN™ Ioflupane (123I) Injection
n=8 Participants
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.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 3.60
|
|
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
|
|
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 outcome
Timeframe: Baseline, and at 48 hours after DaTSCAN™ ioflupane (123I) injectionPopulation: The safety population included all participants who received ioflupane (123I) injection.
Change from baseline in thyroxine, free and triiodothyronine, free were reported.
Outcome measures
| Measure |
DaTSCAN™ Ioflupane (123I) Injection
n=8 Participants
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.
|
|---|---|
|
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
|
|
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
|
|
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 0.3540
|
|
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 outcome
Timeframe: 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.
Change from baseline in alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, creatine kinase, gamma glutamyl transferase, lactate dehydrogenase were reported.
Outcome measures
| Measure |
DaTSCAN™ Ioflupane (123I) Injection
n=8 Participants
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.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 5.40
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 46.10
|
|
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 outcome
Timeframe: Baseline, and at 48 hours after DaTSCAN™ ioflupane (123I) injectionPopulation: The safety population included all participants who received ioflupane (123I) injection.
Change from baseline in thyroxine and triiodothyronine were reported.
Outcome measures
| Measure |
DaTSCAN™ Ioflupane (123I) Injection
n=8 Participants
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.
|
|---|---|
|
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
|
|
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 9.3900
|
|
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
|
|
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 outcome
Timeframe: 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.
Change from baseline in bilirubin, creatinine, direct bilirubin, and urate were reported.
Outcome measures
| Measure |
DaTSCAN™ Ioflupane (123I) Injection
n=8 Participants
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.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 17.50
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 outcome
Timeframe: 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.
Change from baseline in bicarbonate, calcium, chloride, glucose, phosphate, potassium, sodium, urea nitrogen were reported.
Outcome measures
| Measure |
DaTSCAN™ Ioflupane (123I) Injection
n=8 Participants
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.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 0.1390
|
|
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
|
|
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 3.20
|
|
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
|
|
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
|
|
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 0.7060
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 2.20
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 outcome
Timeframe: Baseline, and at 48 hours after DaTSCAN™ ioflupane (123I) injectionPopulation: The safety population included all participants who received ioflupane (123I) injection.
Change from baseline in thyrotropin were reported.
Outcome measures
| Measure |
DaTSCAN™ Ioflupane (123I) Injection
n=8 Participants
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.
|
|---|---|
|
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
|
|
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 0.879050
|
PRIMARY outcome
Timeframe: 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.
Change from baseline in amylase were reported.
Outcome measures
| Measure |
DaTSCAN™ Ioflupane (123I) Injection
n=8 Participants
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.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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 outcome
Timeframe: 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.
Number of participants with clinically significant abnormal pH and specific gravity were reported. Clinical significance was determined by investigator.
Outcome measures
| Measure |
DaTSCAN™ Ioflupane (123I) Injection
n=8 Participants
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.
|
|---|---|
|
Number of Participants With Clinically Significant Abnormal Urinalysis Parameters - pH and Specific Gravity at Pre-specified Timepoints
pH: At Baseline
|
0 Participants
|
|
Number of Participants With Clinically Significant Abnormal Urinalysis Parameters - pH and Specific Gravity at Pre-specified Timepoints
pH: At 3 Hours
|
0 Participants
|
|
Number of Participants With Clinically Significant Abnormal Urinalysis Parameters - pH and Specific Gravity at Pre-specified Timepoints
pH: At 48 Hours
|
0 Participants
|
|
Number of Participants With Clinically Significant Abnormal Urinalysis Parameters - pH and Specific Gravity at Pre-specified Timepoints
pH: At 2 Weeks
|
0 Participants
|
|
Number of Participants With Clinically Significant Abnormal Urinalysis Parameters - pH and Specific Gravity at Pre-specified Timepoints
Specific gravity: At Baseline
|
0 Participants
|
|
Number of Participants With Clinically Significant Abnormal Urinalysis Parameters - pH and Specific Gravity at Pre-specified Timepoints
Specific gravity: At 3 Hours
|
0 Participants
|
|
Number of Participants With Clinically Significant Abnormal Urinalysis Parameters - pH and Specific Gravity at Pre-specified Timepoints
Specific gravity: At 48 Hours
|
0 Participants
|
|
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 outcome
Timeframe: Baseline, up to 4 hours after DaTSCAN™ ioflupane (123I) injectionPopulation: The safety population included all participants who received ioflupane (123I) injection.
Any radiopharmaceutical extravasation, bleeding, hematoma, redness, infection, or other findings were considered as abnormal findings.
Outcome measures
| Measure |
DaTSCAN™ Ioflupane (123I) Injection
n=8 Participants
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.
|
|---|---|
|
Number of Participants Who Reported Abnormal Injection Site Monitoring Findings at Pre-specified Timepoints
|
0 Participants
|
PRIMARY outcome
Timeframe: 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.
Change from baseline in systolic blood pressure were reported.
Outcome measures
| Measure |
DaTSCAN™ Ioflupane (123I) Injection
n=8 Participants
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.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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 4.80
|
|
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
|
|
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 7.90
|
|
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
|
|
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
|
|
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
|
|
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 outcome
Timeframe: 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.
Change from baseline in diastolic blood pressure were reported.
Outcome measures
| Measure |
DaTSCAN™ Ioflupane (123I) Injection
n=8 Participants
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.
|
|---|---|
|
Change From Baseline in Vital Sign-Diastolic Blood Pressure at Pre-specified Timepoints
At Baseline
|
77.8 mmHg
Standard Deviation 5.39
|
|
Change From Baseline in Vital Sign-Diastolic Blood Pressure at Pre-specified Timepoints
Change at 10 minutes
|
-3.3 mmHg
Standard Deviation 4.74
|
|
Change From Baseline in Vital Sign-Diastolic Blood Pressure at Pre-specified Timepoints
Change at 20 minutes
|
-3.6 mmHg
Standard Deviation 5.68
|
|
Change From Baseline in Vital Sign-Diastolic Blood Pressure at Pre-specified Timepoints
Change at 30 minutes
|
-5.5 mmHg
Standard Deviation 8.28
|
|
Change From Baseline in Vital Sign-Diastolic Blood Pressure at Pre-specified Timepoints
Change at 1 hour
|
-2.3 mmHg
Standard Deviation 7.98
|
|
Change From Baseline in Vital Sign-Diastolic Blood Pressure at Pre-specified Timepoints
Change at 2 hours
|
-1.8 mmHg
Standard Deviation 9.66
|
|
Change From Baseline in Vital Sign-Diastolic Blood Pressure at Pre-specified Timepoints
Change at 4 hours
|
-3.3 mmHg
Standard Deviation 7.38
|
|
Change From Baseline in Vital Sign-Diastolic Blood Pressure at Pre-specified Timepoints
Change at 24 hours
|
-4.4 mmHg
Standard Deviation 5.18
|
|
Change From Baseline in Vital Sign-Diastolic Blood Pressure at Pre-specified Timepoints
Change at 48 hours
|
0.0 mmHg
Standard Deviation 5.66
|
|
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 outcome
Timeframe: 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.
Change from baseline in heart rate were reported.
Outcome measures
| Measure |
DaTSCAN™ Ioflupane (123I) Injection
n=8 Participants
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.
|
|---|---|
|
Change From Baseline in Vital Sign-Heart Rate at Pre-specified Timepoints
At Baseline
|
74.4 beats/min
Standard Deviation 12.84
|
|
Change From Baseline in Vital Sign-Heart Rate at Pre-specified Timepoints
Change at 10 minutes
|
0.0 beats/min
Standard Deviation 10.49
|
|
Change From Baseline in Vital Sign-Heart Rate at Pre-specified Timepoints
Change at 20 minutes
|
-2.1 beats/min
Standard Deviation 7.40
|
|
Change From Baseline in Vital Sign-Heart Rate at Pre-specified Timepoints
Change at 30 minutes
|
-4.6 beats/min
Standard Deviation 9.90
|
|
Change From Baseline in Vital Sign-Heart Rate at Pre-specified Timepoints
Change at 1 hour
|
-5.9 beats/min
Standard Deviation 9.61
|
|
Change From Baseline in Vital Sign-Heart Rate at Pre-specified Timepoints
Change at 2 hours
|
-4.0 beats/min
Standard Deviation 5.61
|
|
Change From Baseline in Vital Sign-Heart Rate at Pre-specified Timepoints
Change at 4 hours
|
0.0 beats/min
Standard Deviation 6.89
|
|
Change From Baseline in Vital Sign-Heart Rate at Pre-specified Timepoints
Change at 24 hours
|
-2.6 beats/min
Standard Deviation 8.25
|
|
Change From Baseline in Vital Sign-Heart Rate at Pre-specified Timepoints
Change at 48 hours
|
0.0 beats/min
Standard Deviation 9.46
|
|
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 outcome
Timeframe: 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.
Change from baseline in temperature were reported.
Outcome measures
| Measure |
DaTSCAN™ Ioflupane (123I) Injection
n=8 Participants
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.
|
|---|---|
|
Change From Baseline in Vital Sign-Temperature at Pre-specified Timepoints
At Baseline
|
36.45 degrees celsius (°C)
Standard Deviation 0.239
|
|
Change From Baseline in Vital Sign-Temperature at Pre-specified Timepoints
Change at 10 minutes
|
0.14 degrees celsius (°C)
Standard Deviation 0.350
|
|
Change From Baseline in Vital Sign-Temperature at Pre-specified Timepoints
Change at 20 minutes
|
0.13 degrees celsius (°C)
Standard Deviation 0.519
|
|
Change From Baseline in Vital Sign-Temperature at Pre-specified Timepoints
Change at 30 minutes
|
0.13 degrees celsius (°C)
Standard Deviation 0.301
|
|
Change From Baseline in Vital Sign-Temperature at Pre-specified Timepoints
Change at 1 hour
|
0.13 degrees celsius (°C)
Standard Deviation 0.255
|
|
Change From Baseline in Vital Sign-Temperature at Pre-specified Timepoints
Change at 2 hours
|
0.10 degrees celsius (°C)
Standard Deviation 0.273
|
|
Change From Baseline in Vital Sign-Temperature at Pre-specified Timepoints
Change at 4 hours
|
0.13 degrees celsius (°C)
Standard Deviation 0.377
|
|
Change From Baseline in Vital Sign-Temperature at Pre-specified Timepoints
Change at 24 hours
|
-0.04 degrees celsius (°C)
Standard Deviation 0.389
|
|
Change From Baseline in Vital Sign-Temperature at Pre-specified Timepoints
Change at 48 hours
|
0.14 degrees celsius (°C)
Standard Deviation 0.316
|
|
Change From Baseline in Vital Sign-Temperature at Pre-specified Timepoints
Change at 2 weeks
|
0.11 degrees celsius (°C)
Standard Deviation 0.290
|
PRIMARY outcome
Timeframe: 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.
Change from baseline in respiratory rate were reported.
Outcome measures
| Measure |
DaTSCAN™ Ioflupane (123I) Injection
n=8 Participants
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.
|
|---|---|
|
Change From Baseline in Vital Sign-Respiratory Rate at Pre-specified Timepoints
At Baseline
|
18.4 breaths/min
Standard Deviation 1.19
|
|
Change From Baseline in Vital Sign-Respiratory Rate at Pre-specified Timepoints
Change at 10 minutes
|
-0.9 breaths/min
Standard Deviation 1.73
|
|
Change From Baseline in Vital Sign-Respiratory Rate at Pre-specified Timepoints
Change at 20 minutes
|
-1.0 breaths/min
Standard Deviation 1.15
|
|
Change From Baseline in Vital Sign-Respiratory Rate at Pre-specified Timepoints
Change at 30 minutes
|
-1.4 breaths/min
Standard Deviation 1.92
|
|
Change From Baseline in Vital Sign-Respiratory Rate at Pre-specified Timepoints
Change at 1 hour
|
-1.1 breaths/min
Standard Deviation 1.64
|
|
Change From Baseline in Vital Sign-Respiratory Rate at Pre-specified Timepoints
Change at 2 hours
|
-0.8 breaths/min
Standard Deviation 1.39
|
|
Change From Baseline in Vital Sign-Respiratory Rate at Pre-specified Timepoints
Change at 4 hours
|
-0.3 breaths/min
Standard Deviation 1.83
|
|
Change From Baseline in Vital Sign-Respiratory Rate at Pre-specified Timepoints
Change at 24 hours
|
-0.8 breaths/min
Standard Deviation 1.58
|
|
Change From Baseline in Vital Sign-Respiratory Rate at Pre-specified Timepoints
Change at 48 hours
|
-0.9 breaths/min
Standard Deviation 0.99
|
|
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 outcome
Timeframe: 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.
Change from baseline in oxygen saturation were reported.
Outcome measures
| Measure |
DaTSCAN™ Ioflupane (123I) Injection
n=8 Participants
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.
|
|---|---|
|
Change From Baseline in Oxygen Saturation at Pre-specified Timepoints
At Baseline
|
98.0 percent oxygen (%)
Standard Deviation 1.93
|
|
Change From Baseline in Oxygen Saturation at Pre-specified Timepoints
Change at 10 minutes
|
-0.5 percent oxygen (%)
Standard Deviation 1.31
|
|
Change From Baseline in Oxygen Saturation at Pre-specified Timepoints
Change at 20 minutes
|
0.0 percent oxygen (%)
Standard Deviation 3.16
|
|
Change From Baseline in Oxygen Saturation at Pre-specified Timepoints
Change at 30 minutes
|
-0.8 percent oxygen (%)
Standard Deviation 2.05
|
|
Change From Baseline in Oxygen Saturation at Pre-specified Timepoints
Change at 1 hour
|
0.1 percent oxygen (%)
Standard Deviation 1.81
|
|
Change From Baseline in Oxygen Saturation at Pre-specified Timepoints
Change at 2 hours
|
0.1 percent oxygen (%)
Standard Deviation 2.47
|
|
Change From Baseline in Oxygen Saturation at Pre-specified Timepoints
Change at 4 hours
|
0.6 percent oxygen (%)
Standard Deviation 2.13
|
|
Change From Baseline in Oxygen Saturation at Pre-specified Timepoints
Change at 24 hours
|
1.0 percent oxygen (%)
Standard Deviation 2.33
|
|
Change From Baseline in Oxygen Saturation at Pre-specified Timepoints
Change at 48 hours
|
0.3 percent oxygen (%)
Standard Deviation 3.01
|
|
Change From Baseline in Oxygen Saturation at Pre-specified Timepoints
Change at 2 weeks
|
-0.9 percent oxygen (%)
Standard Deviation 2.23
|
PRIMARY outcome
Timeframe: Baseline, 2 and 5 hours after DaTSCAN™ ioflupane (123I) injectionPopulation: 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.
Change from baseline in PR interval, QRS interval, QT interval, QTC interval, RR interval, QTCF interval, QTCB interval were reported.
Outcome measures
| Measure |
DaTSCAN™ Ioflupane (123I) Injection
n=8 Participants
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.
|
|---|---|
|
Change From Baseline in Electrocardiogram (ECG) Findings at Pre-specified Timepoints
PR Interval: At Baseline
|
161.3 milliseconds (msec)
Standard Deviation 27.46
|
|
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
|
|
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
|
|
Change From Baseline in Electrocardiogram (ECG) Findings at Pre-specified Timepoints
QRS Interval: At Baseline
|
93.0 milliseconds (msec)
Standard Deviation 10.09
|
|
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
|
|
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
|
|
Change From Baseline in Electrocardiogram (ECG) Findings at Pre-specified Timepoints
QT Interval: At Baseline
|
406.0 milliseconds (msec)
Standard Deviation 25.94
|
|
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
|
|
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
|
|
Change From Baseline in Electrocardiogram (ECG) Findings at Pre-specified Timepoints
QTC Interval: At Baseline
|
419.9 milliseconds (msec)
Standard Deviation 14.62
|
|
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
|
|
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
|
|
Change From Baseline in Electrocardiogram (ECG) Findings at Pre-specified Timepoints
RR Interval: At Baseline
|
910.0 milliseconds (msec)
Standard Deviation 141.42
|
|
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
|
|
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
|
|
Change From Baseline in Electrocardiogram (ECG) Findings at Pre-specified Timepoints
QTCF Interval: At Baseline
|
419.9 milliseconds (msec)
Standard Deviation 15.61
|
|
Change From Baseline in Electrocardiogram (ECG) Findings at Pre-specified Timepoints
QTCF Interval: Change at 2 hours
|
-3.1 milliseconds (msec)
Standard Deviation 9.40
|
|
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
|
|
Change From Baseline in Electrocardiogram (ECG) Findings at Pre-specified Timepoints
QTCB Interval: At Baseline
|
427.6 milliseconds (msec)
Standard Deviation 20.32
|
|
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
|
|
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
|
SECONDARY outcome
Timeframe: Pre-dose, 5, 15, 30 minutes and 1, 2, 3, 4, 5, 24, and 48 hours after DaTSCAN™ ioflupane (123I) injectionPopulation: 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.
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.
Outcome measures
| Measure |
DaTSCAN™ Ioflupane (123I) Injection
n=8 Participants
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.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Blood (Plasma and Whole Blood)
Plasma: 4 hours
|
1.229 %IA
Standard Deviation 0.3360
|
|
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
|
|
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
|
|
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
|
|
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
|
|
Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Blood (Plasma and Whole Blood)
Whole Blood: 5 minutes
|
4.564 %IA
Standard Deviation 1.4710
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 outcome
Timeframe: 10 minutes and 1, 2, 4, 5, 24, and 48 hours after DaTSCAN™ ioflupane (123I) injectionPopulation: 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.
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.
Outcome measures
| Measure |
DaTSCAN™ Ioflupane (123I) Injection
n=8 Participants
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.
|
|---|---|
|
Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image
Heart: 1 hour
|
1.09 %IA
Standard Deviation 0.323
|
|
Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image
Heart: 2 hour
|
1.09 %IA
Standard Deviation 0.259
|
|
Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image
Heart: 4 hour
|
0.83 %IA
Standard Deviation 0.189
|
|
Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image
Heart: 5 hour
|
0.83 %IA
Standard Deviation 0.214
|
|
Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image
Heart: 24 hour
|
0.54 %IA
Standard Deviation 0.245
|
|
Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image
Heart: 48 hour
|
0.35 %IA
Standard Deviation 0.107
|
|
Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image
Intestines: 10 minutes
|
6.30 %IA
Standard Deviation 2.821
|
|
Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image
Intestines: 1 hour
|
7.69 %IA
Standard Deviation 2.569
|
|
Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image
Intestines: 2 hour
|
8.95 %IA
Standard Deviation 3.254
|
|
Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image
Intestines: 4 hour
|
8.27 %IA
Standard Deviation 3.355
|
|
Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image
Intestines: 5 hour
|
8.91 %IA
Standard Deviation 3.550
|
|
Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image
Intestines: 24 hour
|
7.25 %IA
Standard Deviation 3.013
|
|
Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image
Intestines: 48 hour
|
5.29 %IA
Standard Deviation 2.523
|
|
Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image
Liver: 10 minutes
|
14.14 %IA
Standard Deviation 2.392
|
|
Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image
Liver: 1 hour
|
14.31 %IA
Standard Deviation 3.419
|
|
Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image
Liver: 2 hour
|
12.08 %IA
Standard Deviation 3.066
|
|
Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image
Liver: 4 hour
|
7.84 %IA
Standard Deviation 0.914
|
|
Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image
Liver: 5 hour
|
7.21 %IA
Standard Deviation 0.975
|
|
Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image
Liver: 24 hour
|
4.80 %IA
Standard Deviation 1.611
|
|
Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image
Liver: 48 hour
|
3.13 %IA
Standard Deviation 0.772
|
|
Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image
Lungs: 10 minutes
|
12.65 %IA
Standard Deviation 1.977
|
|
Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image
Lungs: 1 hour
|
11.80 %IA
Standard Deviation 1.788
|
|
Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image
Lungs: 2 hour
|
11.59 %IA
Standard Deviation 1.705
|
|
Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image
Lungs: 4 hour
|
10.61 %IA
Standard Deviation 1.152
|
|
Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image
Lungs: 5 hour
|
10.20 %IA
Standard Deviation 1.425
|
|
Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image
Lungs: 24 hour
|
7.36 %IA
Standard Deviation 1.682
|
|
Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image
Lungs: 48 hour
|
5.04 %IA
Standard Deviation 1.440
|
|
Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image
Salivary Glands: 10 minutes
|
0.05 %IA
Standard Deviation 0.053
|
|
Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image
Salivary Glands: 1 hour
|
0.03 %IA
Standard Deviation 0.046
|
|
Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image
Salivary Glands: 2 hour
|
0.05 %IA
Standard Deviation 0.053
|
|
Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image
Salivary Glands: 4 hour
|
0.04 %IA
Standard Deviation 0.053
|
|
Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image
Salivary Glands: 5 hour
|
0.06 %IA
Standard Deviation 0.053
|
|
Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image
Salivary Glands: 24 hour
|
0.03 %IA
Standard Deviation 0.046
|
|
Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image
Salivary Glands: 48 hour
|
0.01 %IA
Standard Deviation 0.035
|
|
Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image
Spleen: 10 minutes
|
0.75 %IA
Standard Deviation 0.330
|
|
Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image
Spleen: 1 hour
|
0.65 %IA
Standard Deviation 0.239
|
|
Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image
Spleen: 2 hour
|
0.64 %IA
Standard Deviation 0.185
|
|
Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image
Spleen: 4 hour
|
0.41 %IA
Standard Deviation 0.168
|
|
Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image
Spleen: 5 hour
|
0.43 %IA
Standard Deviation 0.180
|
|
Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image
Spleen: 24 hour
|
0.26 %IA
Standard Deviation 0.074
|
|
Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image
Spleen: 48 hour
|
0.16 %IA
Standard Deviation 0.092
|
|
Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image
Stomach: 10 minutes
|
1.74 %IA
Standard Deviation 0.684
|
|
Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image
Stomach: 1 hour
|
1.53 %IA
Standard Deviation 0.557
|
|
Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image
Stomach: 2 hour
|
1.34 %IA
Standard Deviation 0.450
|
|
Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image
Stomach: 4 hour
|
0.76 %IA
Standard Deviation 0.244
|
|
Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image
Stomach: 5 hour
|
0.81 %IA
Standard Deviation 0.204
|
|
Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image
Stomach: 24 hour
|
0.63 %IA
Standard Deviation 0.315
|
|
Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image
Stomach: 48 hour
|
0.44 %IA
Standard Deviation 0.130
|
|
Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image
Striatum: 10 minutes
|
1.30 %IA
Standard Deviation 0.293
|
|
Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image
Striatum: 1 hour
|
1.08 %IA
Standard Deviation 0.249
|
|
Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image
Striatum: 2 hour
|
0.99 %IA
Standard Deviation 0.259
|
|
Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image
Striatum: 4 hour
|
0.90 %IA
Standard Deviation 0.216
|
|
Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image
Striatum: 5 hour
|
0.87 %IA
Standard Deviation 0.229
|
|
Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image
Striatum: 24 hour
|
0.58 %IA
Standard Deviation 0.167
|
|
Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image
Striatum: 48 hour
|
0.39 %IA
Standard Deviation 0.099
|
|
Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image
Thyroid: 10 minutes
|
0.09 %IA
Standard Deviation 0.064
|
|
Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image
Thyroid: 1 hour
|
0.08 %IA
Standard Deviation 0.071
|
|
Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image
Thyroid: 2 hour
|
0.08 %IA
Standard Deviation 0.046
|
|
Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image
Thyroid: 4 hour
|
0.07 %IA
Standard Deviation 0.049
|
|
Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image
Thyroid: 5 hour
|
0.06 %IA
Standard Deviation 0.053
|
|
Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image
Thyroid: 24 hour
|
0.00 %IA
Standard Deviation 0.000
|
|
Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image
Thyroid: 48 hour
|
0.01 %IA
Standard Deviation 0.035
|
|
Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image
Whole body: 10 minutes
|
104.09 %IA
Standard Deviation 13.451
|
|
Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image
Whole body: 1 hour
|
104.63 %IA
Standard Deviation 14.962
|
|
Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image
Whole body: 2 hour
|
103.41 %IA
Standard Deviation 12.974
|
|
Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image
Whole body: 4 hour
|
96.04 %IA
Standard Deviation 10.938
|
|
Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image
Whole body: 5 hour
|
94.53 %IA
Standard Deviation 10.859
|
|
Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image
Whole body: 24 hour
|
75.96 %IA
Standard Deviation 10.908
|
|
Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image
Whole body: 48 hour
|
59.48 %IA
Standard Deviation 10.573
|
|
Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image
Whole Brain: 10 minutes
|
6.54 %IA
Standard Deviation 1.537
|
|
Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image
Whole Brain: 1 hour
|
4.96 %IA
Standard Deviation 1.302
|
|
Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image
Whole Brain: 2 hour
|
4.60 %IA
Standard Deviation 1.164
|
|
Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image
Whole Brain: 4 hour
|
4.26 %IA
Standard Deviation 1.013
|
|
Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image
Whole Brain: 5 hour
|
4.10 %IA
Standard Deviation 0.970
|
|
Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image
Whole Brain: 24 hour
|
2.79 %IA
Standard Deviation 0.651
|
|
Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image
Whole Brain: 48 hour
|
2.08 %IA
Standard Deviation 0.437
|
|
Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image
Background: 10 minutes
|
0.63 %IA
Standard Deviation 0.149
|
|
Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image
Background: 1 hour
|
0.59 %IA
Standard Deviation 0.181
|
|
Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image
Background: 2 hour
|
0.59 %IA
Standard Deviation 0.164
|
|
Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image
Background: 4 hour
|
0.64 %IA
Standard Deviation 0.151
|
|
Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image
Background: 5 hour
|
0.60 %IA
Standard Deviation 0.153
|
|
Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image
Background: 24 hour
|
0.45 %IA
Standard Deviation 0.120
|
|
Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image
Background: 48 hour
|
0.33 %IA
Standard Deviation 0.104
|
|
Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image
Heart: 10 minutes
|
1.28 %IA
Standard Deviation 0.427
|
SECONDARY outcome
Timeframe: Up to 48 hours after DaTSCAN™ ioflupane (123I) injectionPopulation: 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.
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.
Outcome measures
| Measure |
DaTSCAN™ Ioflupane (123I) Injection
n=8 Participants
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.
|
|---|---|
|
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
|
|
Biodistribution by Source Regions Measured by Decay Corrected Normalized Cumulative Activity
Brain
|
0.6598 becquerel·hour/ becquerel (MBq·h / MBq)
Standard Deviation 0.15464
|
|
Biodistribution by Source Regions Measured by Decay Corrected Normalized Cumulative Activity
Gallbladder
|
0.0466 becquerel·hour/ becquerel (MBq·h / MBq)
Standard Deviation 0.01877
|
|
Biodistribution by Source Regions Measured by Decay Corrected Normalized Cumulative Activity
Liver
|
1.2551 becquerel·hour/ becquerel (MBq·h / MBq)
Standard Deviation 0.46846
|
|
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
|
|
Biodistribution by Source Regions Measured by Decay Corrected Normalized Cumulative Activity
Lungs
|
1.664 becquerel·hour/ becquerel (MBq·h / MBq)
Standard Deviation 0.2683
|
|
Biodistribution by Source Regions Measured by Decay Corrected Normalized Cumulative Activity
Remainder
|
9.409 becquerel·hour/ becquerel (MBq·h / MBq)
Standard Deviation 1.0420
|
|
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
|
|
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 outcome
Timeframe: 10 minutes and 1, 2, 3, 4, 5, 5 to 24, and 24 to 48 hours after DaTSCAN™ ioflupane (123I) injectionPopulation: 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.
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.
Outcome measures
| Measure |
DaTSCAN™ Ioflupane (123I) Injection
n=8 Participants
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.
|
|---|---|
|
Biodistribution as Measured by Decay-corrected Cumulative 123I Activity Concentration in Excreted Urine
10 min
|
0.00 %IA (per hour)
Standard Deviation 0.00
|
|
Biodistribution as Measured by Decay-corrected Cumulative 123I Activity Concentration in Excreted Urine
1 hour
|
0.83 %IA (per hour)
Standard Deviation 0.82
|
|
Biodistribution as Measured by Decay-corrected Cumulative 123I Activity Concentration in Excreted Urine
2 hour
|
2.76 %IA (per hour)
Standard Deviation 1.96
|
|
Biodistribution as Measured by Decay-corrected Cumulative 123I Activity Concentration in Excreted Urine
3 hour
|
4.97 %IA (per hour)
Standard Deviation 1.33
|
|
Biodistribution as Measured by Decay-corrected Cumulative 123I Activity Concentration in Excreted Urine
4 hour
|
6.28 %IA (per hour)
Standard Deviation 1.52
|
|
Biodistribution as Measured by Decay-corrected Cumulative 123I Activity Concentration in Excreted Urine
5 hour
|
8.37 %IA (per hour)
Standard Deviation 1.73
|
|
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
|
|
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 outcome
Timeframe: Up to 48 hours after DaTSCAN™ ioflupane (123I) injectionPopulation: 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.
Sex-averaged normalized organ absorbed doses calculated according to Medical Internal Radiation Dose (MIRD) method.
Outcome measures
| Measure |
DaTSCAN™ Ioflupane (123I) Injection
n=8 Participants
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.
|
|---|---|
|
Normalized Organ Absorbed Doses as Measured by Radiation Dosimetry
Adrenals
|
0.0157 milligray/becquerel (mGy/MBq)
Standard Deviation 0.00161
|
|
Normalized Organ Absorbed Doses as Measured by Radiation Dosimetry
Brain
|
0.0217 milligray/becquerel (mGy/MBq)
Standard Deviation 0.00573
|
|
Normalized Organ Absorbed Doses as Measured by Radiation Dosimetry
Breasts
|
0.0092 milligray/becquerel (mGy/MBq)
Standard Deviation 0.00098
|
|
Normalized Organ Absorbed Doses as Measured by Radiation Dosimetry
Gallbladder Wall
|
0.0301 milligray/becquerel (mGy/MBq)
Standard Deviation 0.00540
|
|
Normalized Organ Absorbed Doses as Measured by Radiation Dosimetry
Heart Wall
|
0.0240 milligray/becquerel (mGy/MBq)
Standard Deviation 0.00478
|
|
Normalized Organ Absorbed Doses as Measured by Radiation Dosimetry
Kidneys
|
0.0132 milligray/becquerel (mGy/MBq)
Standard Deviation 0.00150
|
|
Normalized Organ Absorbed Doses as Measured by Radiation Dosimetry
Liver
|
0.0351 milligray/becquerel (mGy/MBq)
Standard Deviation 0.00838
|
|
Normalized Organ Absorbed Doses as Measured by Radiation Dosimetry
Lower Large Intestine Wall
|
0.0526 milligray/becquerel (mGy/MBq)
Standard Deviation 0.01653
|
|
Normalized Organ Absorbed Doses as Measured by Radiation Dosimetry
Lungs
|
0.0523 milligray/becquerel (mGy/MBq)
Standard Deviation 0.00706
|
|
Normalized Organ Absorbed Doses as Measured by Radiation Dosimetry
Muscle
|
0.0111 milligray/becquerel (mGy/MBq)
Standard Deviation 0.00138
|
|
Normalized Organ Absorbed Doses as Measured by Radiation Dosimetry
Osteogenic Cells
|
0.0331 milligray/becquerel (mGy/MBq)
Standard Deviation 0.00504
|
|
Normalized Organ Absorbed Doses as Measured by Radiation Dosimetry
Ovaries
|
0.0205 milligray/becquerel (mGy/MBq)
Standard Deviation 0.00451
|
|
Normalized Organ Absorbed Doses as Measured by Radiation Dosimetry
Pancreas
|
0.0167 milligray/becquerel (mGy/MBq)
Standard Deviation 0.00194
|
|
Normalized Organ Absorbed Doses as Measured by Radiation Dosimetry
Red Marrow
|
0.0108 milligray/becquerel (mGy/MBq)
Standard Deviation 0.00129
|
|
Normalized Organ Absorbed Doses as Measured by Radiation Dosimetry
Skin
|
0.0069 milligray/becquerel (mGy/MBq)
Standard Deviation 0.00086
|
|
Normalized Organ Absorbed Doses as Measured by Radiation Dosimetry
Small Intestine
|
0.0263 milligray/becquerel (mGy/MBq)
Standard Deviation 0.00675
|
|
Normalized Organ Absorbed Doses as Measured by Radiation Dosimetry
Spleen
|
0.0183 milligray/becquerel (mGy/MBq)
Standard Deviation 0.00550
|
|
Normalized Organ Absorbed Doses as Measured by Radiation Dosimetry
Stomach Wall
|
0.0216 milligray/becquerel (mGy/MBq)
Standard Deviation 0.00439
|
|
Normalized Organ Absorbed Doses as Measured by Radiation Dosimetry
Testes
|
0.0086 milligray/becquerel (mGy/MBq)
Standard Deviation 0.00091
|
|
Normalized Organ Absorbed Doses as Measured by Radiation Dosimetry
Thymus
|
0.0123 milligray/becquerel (mGy/MBq)
Standard Deviation 0.00149
|
|
Normalized Organ Absorbed Doses as Measured by Radiation Dosimetry
Thyroid
|
0.0166 milligray/becquerel (mGy/MBq)
Standard Deviation 0.00471
|
|
Normalized Organ Absorbed Doses as Measured by Radiation Dosimetry
Total Body
|
0.0136 milligray/becquerel (mGy/MBq)
Standard Deviation 0.00162
|
|
Normalized Organ Absorbed Doses as Measured by Radiation Dosimetry
Upper Large Intestine Wall
|
0.0480 milligray/becquerel (mGy/MBq)
Standard Deviation 0.01548
|
|
Normalized Organ Absorbed Doses as Measured by Radiation Dosimetry
Urinary Bladder Wall
|
0.0602 milligray/becquerel (mGy/MBq)
Standard Deviation 0.01423
|
|
Normalized Organ Absorbed Doses as Measured by Radiation Dosimetry
Uterus
|
0.0184 milligray/becquerel (mGy/MBq)
Standard Deviation 0.00281
|
SECONDARY outcome
Timeframe: Up to 48 hours after DaTSCAN™ ioflupane (123I) injectionPopulation: 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.
The ED per unit of administered activity was evaluated from the ensemble of absorbed dose data.
Outcome measures
| Measure |
DaTSCAN™ Ioflupane (123I) Injection
n=8 Participants
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.
|
|---|---|
|
Effective Dose (ED) of Ioflupane (123I) Injection After IV Administration
|
0.0280 millisievert/becquerel (mSv/MBq)
Standard Deviation 0.00448
|
Adverse Events
DaTSCAN™ Ioflupane (123I) Injection
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
DaTSCAN™ Ioflupane (123I) Injection
n=8 participants at risk
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.
|
|---|---|
|
Endocrine disorders
Thyroiditis chronic
|
25.0%
2/8 • Number of events 2 • Baseline up to 2 weeks after IMP administration (i.e., up to 16 days)
|
|
Investigations
Neutrophil count decreased
|
25.0%
2/8 • Number of events 2 • Baseline up to 2 weeks after IMP administration (i.e., up to 16 days)
|
|
Investigations
Aspartate aminotransferase increased
|
12.5%
1/8 • Number of events 1 • Baseline up to 2 weeks after IMP administration (i.e., up to 16 days)
|
|
Investigations
Protein urine present
|
12.5%
1/8 • Number of events 1 • Baseline up to 2 weeks after IMP administration (i.e., up to 16 days)
|
|
Investigations
Red blood cells urine positive
|
12.5%
1/8 • Number of events 1 • Baseline up to 2 weeks after IMP administration (i.e., up to 16 days)
|
|
Investigations
Urinary occult blood positive
|
12.5%
1/8 • Number of events 1 • Baseline up to 2 weeks after IMP administration (i.e., up to 16 days)
|
|
Investigations
White blood cell count decreased
|
12.5%
1/8 • Number of events 1 • Baseline up to 2 weeks after IMP administration (i.e., up to 16 days)
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
12.5%
1/8 • Number of events 1 • Baseline up to 2 weeks after IMP administration (i.e., up to 16 days)
|
|
Nervous system disorders
Paraesthesia
|
50.0%
4/8 • Number of events 4 • Baseline up to 2 weeks after IMP administration (i.e., up to 16 days)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI and/or institution is that the Sponsor can review results communications prior to public release and can restrict communications regarding trial results for a period that is more than 30 days (publications/abstracts) but not to exceed 90 days (patent related issues) from the time submitted to the Sponsor to review. The PI may be asked to remove any Sponsor confidential information and/or delay publication to protect any proprietary information.
- Publication restrictions are in place
Restriction type: OTHER