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

Primary Purpose

Chemotherapy Induced Peripheral Neuropathy (CIPN)

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Calmangafodipir
Placebo
Sponsored by
Egetis Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chemotherapy Induced Peripheral Neuropathy (CIPN)

Eligibility Criteria

20 Years - 55 Years (Adult)MaleAccepts 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

Sites / Locations

  • WCCT Global

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Group 1 (Japanese) Calmangafodipir

Group 1 (Japanese) Placebo

Group 2 (Caucasian) Calmangafodipir

Group 2 (Caucasian) Placebo

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Cmax
Maximum plasma concentration during a dosing interval
tmax
Time to reach maximum plasma concentration
AUC(0-last)
Area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentration
Ae
Amount of manganese and zinc excreted into urine
Ae%
Percent of study drug manganese excreted into urine

Full Information

First Posted
February 7, 2018
Last Updated
February 12, 2018
Sponsor
Egetis Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT03430999
Brief Title
SUNCIST: A Study of Calmangafodipir in Healthy Japanese and Caucasian Subjects
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
November 7, 2017 (Actual)
Primary Completion Date
December 18, 2017 (Actual)
Study Completion Date
December 18, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Egetis Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chemotherapy Induced Peripheral Neuropathy (CIPN)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantInvestigator
Masking Description
Double-blind
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1 (Japanese) Calmangafodipir
Arm Type
Experimental
Arm Title
Group 1 (Japanese) Placebo
Arm Type
Placebo Comparator
Arm Title
Group 2 (Caucasian) Calmangafodipir
Arm Type
Experimental
Arm Title
Group 2 (Caucasian) Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Calmangafodipir
Intervention Description
Single ascending doses of 2 μmol/kg, 5 μmol/kg, and 10 μmol/kg
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Number of treatment-emergent adverse events
Description
Subject incidence of treatment-emergent adverse events (TEAEs), which may include changes in laboratory safety tests, electrocardiograms (ECG), and vital signs.
Time Frame
From signing of informed consent through the last follow up visit (up to Day 10)
Secondary Outcome Measure Information:
Title
Cmax
Description
Maximum plasma concentration during a dosing interval
Time Frame
predose and 1 min, 15 min, 30 min, 1 hour, 4 hours, and 8 hours postdose
Title
tmax
Description
Time to reach maximum plasma concentration
Time Frame
predose and 1 min, 15 min, 30 min, 1 hour, 4 hours, and 8 hours postdose
Title
AUC(0-last)
Description
Area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentration
Time Frame
predose and 1 min, 15 min, 30 min, 1 hour, 4 hours, and 8 hours postdose
Title
Ae
Description
Amount of manganese and zinc excreted into urine
Time Frame
4 hours post-dose and 24 hours post-dose
Title
Ae%
Description
Percent of study drug manganese excreted into urine
Time Frame
4 hours and 24 hours post-dose

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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: 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 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
Facility Information:
Facility Name
WCCT Global
City
Cypress
State/Province
California
ZIP/Postal Code
90630
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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