Clinical trial NCT04564092: A Study to Evaluate the Safety, Biodistribution, Internal Radiation Dosimetry, and Effective Dose of DaTSCAN™ Ioflupane (123I) Injection in Chinese Healthy Volunteers.
Official title: A Phase 1, Non-randomised, Noncomparative, Open-label Study to Assess the Safety, Biodistribution, and Internal Radiation Dosimetry of a Single Dose of DaTSCAN™ Ioflupane (123I) Injection in Chinese Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects (HS)
Keywords: Single photon emission computed tomography (SPECT)
Healthy Volunteer (HV)
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
Collaborators: name: PPD Development, LP
First posted: 2020-09-25
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is a phase 1, single-centre, single-group, nonrandomized, noncomparative, open-label, single-dose study to evaluate the safety, biodistribution, internal radiation dosimetry, and effective dose of DaTSCAN™ ioflupane (123I) injection in Chinese Healthy Volunteers.


Eligibility criteria: Inclusion Criteria:

* Chinese male or female who has agreed to sign and date the written informed consent form
* Age 18-70 years
* Body mass index (BMI) of 18-30 kg/m\^2
* General good state of health as judged by a qualified physician after completing physical examination
* Fit, co-operative, and able to provide consent

Exclusion Criteria:

* Sensitivity to DaTSCAN™ ioflupane (123I) injection or any of its ingredients
* A history of motor disturbances
* A history of pulmonary, cardiovascular, neurological, renal or hepatic, hormonal or coagulation disorders or hyperthyroidism
* A history of drug, alcohol, or solvent abuse
* The subject has been previously enrolled in this study or participated in a clinical study involving an investigational pharmaceutical product within 30 days prior to screening
* Radionuclide injection within a minimum of 5 radioactive half-lives prior to screening
* Use of any medication (except paracetamol \[acetaminophen\] or oral contraceptive), including traditional Chinese medicine, within 2 weeks prior to the imaging visit
* Classification as a radiation worker
* Women of child-bearing potential not accepting a highly effective method of birth control (A woman is considered of child-bearing potential, i.e., fertile, following menarche and until becoming postmenopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. Postmenopausal is defined as 12 months with no menses without an alternative medical cause, in International Council on Harmonisation (ICH) M3 (R2); A highly effective method of birth control is defined as one which results in a low failure rate (i.e., less than 1 % per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, some intrauterine devices, sexual abstinence or vasectomised partner, in ICH M3 (R2).
* Pregnant or lactating women

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Baseline up to 2 weeks after IMP administration (i.e., up to 16 days)
measure: 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)
timeFrame: 1 hour before injection (baseline), and at approximately 15 minutes, 1, 4, 24, 48 hours after DaTSCAN™ ioflupane (123I) injection
measure: Number of Participants With Clinically Significant Change From Baseline in Physical Examination Findings Pre-specified Timepoints
timeFrame: Baseline, 4 hours after injection and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)
measure: Change From Baseline in Hematology Parameters at Pre-specified Timepoints
timeFrame: Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)
measure: Change From Baseline in Hematology Parameter-C Reactive Protein at Pre-specified Timepoints
timeFrame: Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)
measure: Change From Baseline in Hematology Parameter-Hematocrit at Pre-specified Timepoints
timeFrame: Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)
measure: Change From Baseline in Hematology Parameter-Erythrocytes at Pre-specified Timepoints
timeFrame: Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)
measure: Change From Baseline in Hematology Parameters- Leukocytes, Platelets at Pre-specified Timepoints
timeFrame: Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)
measure: Change From Baseline in Hematology Parameters- Fibrinogen, Hemoglobin at Pre-specified Timepoints
timeFrame: Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)
measure: Change From Baseline in Serum Chemistry Parameters- Albumin, Protein at Pre-specified Timepoints
timeFrame: Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)
measure: Change From Baseline in Serum Chemistry Parameters- Thyroxine, Free and Triiodothyronine, Free at Pre-specified Timepoints
timeFrame: Baseline, and at 48 hours after DaTSCAN™ ioflupane (123I) injection
measure: Change From Baseline in Serum Chemistry Parameters at Pre-specified Timepoints
timeFrame: Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)
measure: Change From Baseline in Serum Chemistry Parameters- Thyroxine and Triiodothyronine at Pre-specified Timepoints
timeFrame: Baseline, and at 48 hours after DaTSCAN™ ioflupane (123I) injection
measure: Change From Baseline in Serum Chemistry Parameters- Bilirubin, Creatinine, Direct Bilirubin, and Urate at Pre-specified Timepoints
timeFrame: Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)
measure: Change From Baseline in Serum Chemistry Parameters- Bicarbonate, Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, Urea Nitrogen at Pre-specified Timepoints
timeFrame: Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)
measure: Change From Baseline in Serum Chemistry Parameters- Thyrotropin at Pre-specified Timepoints
timeFrame: Baseline, and at 48 hours after DaTSCAN™ ioflupane (123I) injection
measure: Change From Baseline in Serum Chemistry Parameters- Amylase at Pre-specified Timepoints
timeFrame: Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)
measure: Number of Participants With Clinically Significant Abnormal Urinalysis Parameters - pH and Specific Gravity at Pre-specified Timepoints
timeFrame: Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)
measure: Number of Participants Who Reported Abnormal Injection Site Monitoring Findings at Pre-specified Timepoints
timeFrame: Baseline, up to 4 hours after DaTSCAN™ ioflupane (123I) injection
measure: Change From Baseline in Vital Sign-Systolic Blood Pressure at Pre-specified Timepoints
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)
measure: Change From Baseline in Vital Sign-Diastolic Blood Pressure at Pre-specified Timepoints
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)
measure: Change From Baseline in Vital Sign-Heart Rate at Pre-specified Timepoints
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)
measure: Change From Baseline in Vital Sign-Temperature at Pre-specified Timepoints
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)
measure: Change From Baseline in Vital Sign-Respiratory Rate at Pre-specified Timepoints
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)
measure: Change From Baseline in Oxygen Saturation at Pre-specified Timepoints
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)
measure: Change From Baseline in Electrocardiogram (ECG) Findings at Pre-specified Timepoints
timeFrame: Baseline, 2 and 5 hours after DaTSCAN™ ioflupane (123I) injection
Secondary outcomes:
measure: Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Blood (Plasma and Whole Blood)
timeFrame: Pre-dose, 5, 15, 30 minutes and 1, 2, 3, 4, 5, 24, and 48 hours after DaTSCAN™ ioflupane (123I) injection
measure: Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image
timeFrame: 10 minutes and 1, 2, 4, 5, 24, and 48 hours after DaTSCAN™ ioflupane (123I) injection
measure: Biodistribution by Source Regions Measured by Decay Corrected Normalized Cumulative Activity
timeFrame: Up to 48 hours after DaTSCAN™ ioflupane (123I) injection
measure: Biodistribution as Measured by Decay-corrected Cumulative 123I Activity Concentration in Excreted Urine
timeFrame: 10 minutes and 1, 2, 3, 4, 5, 5 to 24, and 24 to 48 hours after DaTSCAN™ ioflupane (123I) injection
measure: Normalized Organ Absorbed Doses as Measured by Radiation Dosimetry
timeFrame: Up to 48 hours after DaTSCAN™ ioflupane (123I) injection
measure: Effective Dose (ED) of Ioflupane (123I) Injection After IV Administration
timeFrame: Up to 48 hours after DaTSCAN™ ioflupane (123I) injection
Other outcomes:
Locations:
city: Huangpu
country: China
facility: Rujin hospital, affiliated to Shanghai Jiaotong University, School of Medicine
state: Shanghai
Study officials:
affiliation: Rujin Hospital
name: Biao LI
role: PRINCIPAL_INVESTIGATOR
References: