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Completed

NCT Number: NCT03430999

SUNCIST: A Study 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.

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Key information

Conditions

Chemotherapy Induced Peripheral Neuropathy (CIPN)

Age range

20 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

WCCT Global

Cypress, California, 90630, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Calmangafodipir

Drug

Single ascending doses of 2 μmol/kg, 5 μmol/kg, and 10 μmol/kg

Placebo

Drug

Placebo

Primary outcomes

  1. Number of treatment-emergent adverse events

    Time frame: 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 outcomes

  1. Cmax

    Time frame: predose and 1 min, 15 min, 30 min, 1 hour, 4 hours, and 8 hours postdose

    Maximum plasma concentration during a dosing interval

  2. tmax

    Time frame: predose and 1 min, 15 min, 30 min, 1 hour, 4 hours, and 8 hours postdose

    Time to reach maximum plasma concentration

  3. AUC(0-last)

    Time frame: 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

  4. Ae

    Time frame: 4 hours post-dose and 24 hours post-dose

    Amount of manganese and zinc excreted into urine

  5. Ae%

    Time frame: 4 hours and 24 hours post-dose

    Percent of study drug manganese excreted into urine

Sponsors and collaborators

Lead sponsor

Egetis Therapeutics

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Feb 13, 2018
Registry last updated
Feb 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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