Status:
COMPLETED
SUNCIST: A Study of Calmangafodipir in Healthy Japanese and Caucasian Subjects
Lead Sponsor:
Egetis Therapeutics
Conditions:
Chemotherapy Induced Peripheral Neuropathy (CIPN)
Eligibility:
MALE
20-55 years
Phase:
PHASE1
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
November 7 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 18 2017
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT03430999
Start Date
November 7 2017
End Date
December 18 2017
Last Update
February 13 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
WCCT Global
Cypress, California, United States, 90630