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First-in-human study of [18F]DiFA

First-in-human study of [18F]DiFA - First-in-human study of [18F]DiFA

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000022066
Enrollment
8
Registered
2016-05-09
Start date
2016-06-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Normal volunteers

Interventions

Dose:105-740MBq

Sponsors

Hokkaido University Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: Normal volunteers (1)aged 20-60 years old at agreement acquisition. (2)gave a written informed consent. (3)are nonsmokers or the persons who are available for smoking cessation during this study (4)are nondrinkers or the persons who are available for temperance during this study

Exclusion criteria

Exclusion criteria: (1) The person who is abnormal in laboratory study at screening. White blood cell differentiation is excluded) (2)a history of blood, heart, hepatic or renal disease. (3)The person who had an acute disease symptom (nausea, vomiting, fever, diarrhea) within 3 days before screening test (4)any medical treatment including vitamin drug and Kanpo-drug within 7 days before enrollment. (5)a donation of plasma to a blood bank or clinical study within 7 days before enrollment. a donation of over 200 ml whole blood to a blood bank or clinical studywithin 28 days before enrollment. a donation of over 400 ml whole blood to a blood bank or clinical study within 84 days before enrollment. a donation of over 800 ml whole blood to a blood bank or clinical study within 365 days before enrollment. (6) a history of hypersensitivity for medical drugs. (7)a participation in other clinical trials at present or other clinical trial within 6 months before enrollment. (8) a history of drug abuse or alcoholism. (9)The person of the severe claustrophobia. (10) The person who has a history of the poor physical condition by the medical act including drawing blood, the injection (11)and subjects were excluded if the investigators judged as misfit for this study.

Design outcomes

Primary

MeasureTime frame
To clarify the presence or the absence, the type, the severity, and frequency of adverse effects and to assess the causal relationship.

Secondary

MeasureTime frame
Pharmacokinetics Exposure dose

Countries

Japan

Contacts

Public ContactTohru Shiga

Hokkaido University, Graduate School of Medicine Department of Nuclear Medicine

tshiga@med.hokudai.ac.jp011-706-5152

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026