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

Phase 1

Completed

• Conditions: Chemotherapy Induced Peripheral Neuropathy (CIPN)
• Interventions: Drug: Calmangafodipir; Drug: Placebo

• Registration Number: NCT03430999
• Lead Sponsor: Egetis Therapeutics

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-07
• Primary Completion: 2017-12-18
• Study Completion: 2017-12-18
• Status Verified: 2018-02
• Study First Submitted: 2018-02-07
• Study First Submitted QC: 2018-02-12
• Last Update Submitted: 2018-02-12
• Study First Posted: 2018-02-13
• Last Update Posted: 2018-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Group 1 (Japanese) Calmangafodipir	Calmangafodipir	-
Group 1 (Japanese) Placebo	Placebo	-
Group 2 (Caucasian) Calmangafodipir	Calmangafodipir	-
Group 2 (Caucasian) Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Number of treatment-emergent adverse events	From signing of informed consent through the last follow up visit (up to Day 10)	Subject incidence of treatment-emergent adverse events (TEAEs), which may include changes in laboratory safety tests, electrocardiograms (ECG), and vital signs.

Secondary Outcome Measures

Name	Time	Method
Ae%	4 hours and 24 hours post-dose	Percent of study drug manganese excreted into urine
Cmax	predose and 1 min, 15 min, 30 min, 1 hour, 4 hours, and 8 hours postdose	Maximum plasma concentration during a dosing interval
Ae	4 hours post-dose and 24 hours post-dose	Amount of manganese and zinc excreted into urine
tmax	predose and 1 min, 15 min, 30 min, 1 hour, 4 hours, and 8 hours postdose	Time to reach maximum plasma concentration
AUC(0-last)	predose and 1 min, 15 min, 30 min, 1 hour, 4 hours, and 8 hours postdose	Area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentration

Trial Locations

Locations (1)

WCCT Global; 🇺🇸 Cypress, California, United States