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

NCT03430999 | Completed Phase 1 FDA Drug

• 1 other identifier: PP06466
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Chemotherapy Induced Peripheral Neuropathy (CIPN)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Cmax

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

• tmax

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

• AUC(0-last)

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

• Ae

  4 hours post-dose and 24 hours post-dose

• Ae%

  4 hours and 24 hours post-dose

Study Arms (4)

Group 1 (Japanese) Calmangafodipir

EXPERIMENTAL

Drug: Calmangafodipir

Group 1 (Japanese) Placebo

PLACEBO COMPARATOR

Drug: Placebo

Group 2 (Caucasian) Calmangafodipir

EXPERIMENTAL

Drug: Calmangafodipir

Group 2 (Caucasian) Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Calmangafodipir DRUG

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

Group 1 (Japanese) Calmangafodipir; Group 2 (Caucasian) Calmangafodipir

Placebo DRUG

Placebo

Group 1 (Japanese) Placebo; Group 2 (Caucasian) Placebo

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Egetis Therapeutics: lead

Study Sites (1)

WCCT Global

Cypress, California, 90630, United States

Location

MeSH Terms

Interventions

N,N'-bis(pyridoxal-5-phosphate)ethylenediamine-N,N'-diacetic acid

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2018
• First Posted: February 13, 2018
• Study Start: November 7, 2017
• Primary Completion: December 18, 2017
• Study Completion: December 18, 2017
• Last Updated: February 13, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)