SUNCIST: A Study of Calmangafodipir in Healthy Japanese and Caucasian Subjects

• Status: Completed
• Trial end date: 2017-12-18
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Egetis Therapeutics; PledPharma AB
• Treatments: Edetic Acid; Pyridoxal Phosphate

Criteria

Inclusion Criteria:

• 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:

1. Born in Japan

2. Has 2 Japanese biological parents and 4 Japanese biological grandparents

3. Has lived outside of Japan for less than 5 years

4. Has made no significant changes in lifestyle, including diet, since leaving Japan

Exclusion Criteria:

• 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