A Study to Evaluate the Safety, Biodistribution, Internal Radiation Dosimetry, and Effective Dose of DaTSCAN™ Ioflupane (123I) Injection in Chinese Healthy Volunteers.
Study Details
Study Description
Brief Summary
This is a phase 1, single-centre, single-group, nonrandomised, 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: DaTSCAN™ ioflupane (123I) injection Participants will receive a single intravenous (IV) injection of DaTSCAN™ ioflupane (123I) injection into an arm vein, followed by planar whole-body imaging at prespecified time points over a period of 48 hours after administration. Brain SPECT imaging will be acquired at 3 and 6 hours after administration. |
Drug: DaTSCAN™ Ioflupane (123I) Injection
Each subject will receive a single administration of DaTSCAN™ ioflupane (123I) injection by bolus IV injection with a nominal iodine (123I) activity of 111 MBq ±10%, in a maximum volume of 5 mL.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Comparison and assessment of safety parameters and AEs reported by all study participants [38 days]
An overall summary of AEs and DaTSCAN™-emergent AEs will be presented, coded with Medical Dictionary for Regulatory Activities (MedDRA) and summarized by MedDRA system-organ class and preferred term.
- Change in results of a tolerability questionnaire performed pre-injection and post-injection [1 hour before injection and at approximately 15 minutes, 1, 4, 24, 48 hours after DaTSCAN™ ioflupane (123I) injection]
A tolerability score will be determined using 100mm visual analogue scales (VAS). Patients will subjectively evaluate their symptoms (i.e. subject mood, pain at injection site, itchiness of injection site, loss of function at injection site and quality of sleep) using the VAS giving the value they were feeling from none (0mm) to extreme value (100mm). The results of the tolerability questionnaire performed pre- and post-injection will be summarized.
- Change from baseline in the results of physical examinations at prespecified time points [Baseline, 4 hours after injection and 2 weeks after injection]
In this context, baseline is defined as the pre-treatment assessment after the screening visit up to 1 hour prior to DaTSCAN™ ioflupane (123I) injection. The number and percentage of subjects with changes in physical examination status from normal at baseline to abnormal at each post injection time point will be summarized.
- Change from baseline in the results of clinical laboratory tests (haematology, serum biochemistry and urinalysis) at prespecified time points [Baseline, and 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection]
In this context, baseline is defined as the pre-treatment assessment at the screening visit. The occurrence of post-injection values outside of normal limits and changes from baseline will be summarized.
- Change from baseline of Injection site monitoring findings at prespecified time points [Baseline, 1 hour before injection and 4 hours after injection]
In this context, baseline is defined as the pre-treatment assessment after the screening visit up to 1 hour prior to DaTSCAN™ ioflupane (123I) injection. Abnormal injection-site findings at prespecified time points include, but are not limited to, radiopharmaceutical extravasation, bleeding, haematoma, redness, and infection . The incidence of abnormal findings of injection site monitoring pre- and post-injection will be summarized.
- Change from baseline in the results of vital signs (blood pressure in mmHg, heart rate as bpm, body temperature as degree C, respiratory rate per min) and oxygen saturation at prespecified time points [Baseline, 1 hour before injection; 10, 20, 30 minutes and 1, 2, 4, 24, 48 hours and 2 weeks after injection]
In this context, baseline is defined as the pre-treatment assessment after the screening visit up to 1 hour prior to DaTSCAN™ ioflupane (123I) injection. The occurrence of post-injection values outside of normal limits and changes from baseline will be summarized.
- Change from baseline in the results of ECG examinations (PR interval, QTc, QRS and RR interval) at prespecified time points [Baseline, 1 hour before injection, 2 and 5 hours after injection.]
In this context, baseline is defined as the pre-treatment assessment after the screening visit up to 1 hour prior to DaTSCAN™ ioflupane (123I) injection. A standard 12-lead ECG examination will be performed at the investigational site and will be evaluated by a licensed physician. The occurrence of post-injection values outside of normal limits and changes from baseline will be summarized.
Secondary Outcome Measures
- Determine the biodistribution and radiation dosimetry of ioflupane (123I) injection in Chinese Healthy Volunteers. [48 hours]
Biodistribution measurements will include: • Maximun regional tracer uptake as a percentage of injected activity (%IA)
- Determine the biodistribution and radiation dosimetry of ioflupane (123I) injection in Chinese Healthy Volunteers. [48 hours]
Biodistribution measurements will include: • Normalised regional cumulative activity (hours/MBq)
- Determine the biodistribution and radiation dosimetry of ioflupane (123I) injection in Chinese Healthy Volunteers. [48 hours]
Biodistribution measurements will include: • Whole blood, plasma, and excreted urine activity concentration (Bq/ml)
- Determine the biodistribution and radiation dosimetry of ioflupane (123I) injection in Chinese Healthy Volunteers. [48 hours]
Biodistribution measurements will include: • Renal and hepatobiliary tracer excretion rates (per hour)
- Determine the biodistribution and radiation dosimetry of ioflupane (123I) injection in Chinese Healthy Volunteers. [48 hours]
Dosimetry calculations will include: • Organ level absorbed dose (mGy/MBq)
- Determine the biodistribution and radiation dosimetry of ioflupane (123I) injection in Chinese Healthy Volunteers. [48 hours]
Dosimetry calculations will include: • Effective dose (mSv/MBq)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Chinese male or female who has agreed to sign and date the written informed consent form
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Age 18-70 years
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Body mass index (BMI) of 18-30 kg/m2
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General good state of health as judged by a qualified physician after completing physical examination
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Fit, co-operative, and able to provide consent
Exclusion Criteria:
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Sensitivity to DaTSCAN™ ioflupane (123I) injection or any of its ingredients
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A history of motor disturbances
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A history of pulmonary, cardiovascular, neurological, renal or hepatic, hormonal or coagulation disorders or hyperthyroidism
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A history of drug, alcohol, or solvent abuse
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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
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Radionuclide injection within a minimum of 5 radioactive half-lives prior to screening
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Use of any medication (except paracetamol [acetaminophen] or oral contraceptive), including traditional Chinese medicine, within 2 weeks prior to the imaging visit
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Classification as a radiation worker
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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).)
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Pregnant or lactating women
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Rujin hospital, affiliated to Shanghai Jiaotong University, School of Medicine | Huangpu | Shanghai | China | 200025 |
Sponsors and Collaborators
- GE Healthcare
- PPD
Investigators
- Principal Investigator: Biao LI, Rujin Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- GE-001-023