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

Egetis Therapeutics

Status and phase: Completed; Phase 1

Conditions: Chemotherapy Induced Peripheral Neuropathy (CIPN)

Treatments: Drug: Calmangafodipir; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03430999

PP06466

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: Male

Ages: 20 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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48 participants in 4 patient groups, including a placebo group

Group 1 (Japanese) Calmangafodipir

Experimental group

Treatment:

Drug: Calmangafodipir

Group 1 (Japanese) Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Group 2 (Caucasian) Calmangafodipir

Experimental group

Treatment:

Drug: Calmangafodipir

Group 2 (Caucasian) Placebo

Placebo Comparator group

Treatment:

Drug: Placebo