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

SUNCIST: A Phase I, Randomized, Double-Blind, Placebo-Controlled, Ascending, Single-Dose Study to Assess the Safety, Tolerability, Pharmacokinetics of Intravenous Administration of Calmangafodipir in Healthy Japanese and Caucasian Subjects

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.

Study Overview

• Status: Completed
• Conditions: Chemotherapy Induced Peripheral Neuropathy (CIPN)
• Intervention / Treatment: Drug: Placebo; Drug: Calmangafodipir

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Cypress, California, United States, 90630
      • WCCT Global

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1 (Japanese) Calmangafodipir	Drug: Calmangafodipir; Single ascending doses of 2 μmol/kg, 5 μmol/kg, and 10 μmol/kg
Placebo Comparator: Group 1 (Japanese) Placebo	Drug: Placebo; Placebo
Experimental: Group 2 (Caucasian) Calmangafodipir	Drug: Calmangafodipir; Single ascending doses of 2 μmol/kg, 5 μmol/kg, and 10 μmol/kg
Placebo Comparator: Group 2 (Caucasian) Placebo	Drug: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Egetis Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2017
• Primary Completion (Actual): December 18, 2017
• Study Completion (Actual): December 18, 2017

Study Registration Dates

• First Submitted: February 7, 2018
• First Submitted That Met QC Criteria: February 12, 2018
• First Posted (Actual): February 13, 2018

Study Record Updates

• Last Update Posted (Actual): February 13, 2018
• Last Update Submitted That Met QC Criteria: February 12, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases
• Other Study ID Numbers: PP06466

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No