SUNCIST: A Study of Calmangafodipir in Healthy Japanese and Caucasian Subjects
Completed · Phase 1 · Has a placebo group
Conditions studied: Chemotherapy Induced Peripheral Neuropathy (CIPN)
In brief
Randomized, double-bline, placebo-controlled, single dose study comparing the pharmacokinetics (PK) and safety of PP095-01 in Japanese and non-Asian (eg, Caucasian) subjects.
Key facts
- Study ID
- NCT03430999
- Run by
- Egetis Therapeutics
- People needed
- 48
- Starts
- 2017-11-07
- Expected to finish
- 2017-12-18
- Last updated by the study team
- 2018-02-13
Who can join
Age: 20 and older, up to 55. Sex: male. Healthy volunteers: accepted.
You may qualify if…
- BMI within 18.0 to 30.0 kg/m2 and body weight not less than 50 kg
- Blood pressure between 90 and 140 mmHg systolic, and no higher than 90 mmHg diastolic
- Non-smoker or not smoking for at least 12 months
- Be first generation Japanese (For Group 1 only), defined as:
- Born in Japan
- Has 2 Japanese biological parents and 4 Japanese biological grandparents
- Has lived outside of Japan for less than 5 years
- Has made no significant changes in lifestyle, including diet, since leaving Japan
You may not qualify if…
- Clinically significant abnormal values for hematology, clinical chemistry, urinalysis, physical exam, vital signs, or electrocardiogram at screening
- Has a history of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV; has a history of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) positive, or other clinically active liver disease, or tests positive for HBsAg or anti-HCV at Screening.
- Has a history of drug or alcohol abuse
- Has previously received calmangafodipir or mangafodipir
- Welders, mine workers, or other workers in occupations (current or past) where high manganese exposure is likely
Where it is running
- WCCT Global — Cypress, California, United States
Full record on ClinicalTrials.gov
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