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

Chemotherapy Induced Peripheral Neuropathy (CIPN) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03430999
• Other study ID #: PP06466
• Status: Completed
• Phase: Phase 1
• First received: February 7, 2018
• Last updated: February 12, 2018
• Start date: November 7, 2017
• Est. completion date: December 18, 2017

Study information

• Verified date: February 2018
• Source: PledPharma AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 18, 2017
• Est. primary completion date: December 18, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Chemotherapy Induced Peripheral Neuropathy (CIPN)
• Peripheral Nervous System Diseases

Intervention

Drug:
• Calmangafodipir
Single ascending doses of 2 µmol/kg, 5 µmol/kg, and 10 µmol/kg
• Placebo
Placebo

Locations

Country	Name	City	State
United States	WCCT Global	Cypress	California

Sponsors (1)

Lead Sponsor	Collaborator
PledPharma AB

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Cmax	Maximum plasma concentration during a dosing interval	predose and 1 min, 15 min, 30 min, 1 hour, 4 hours, and 8 hours postdose
Secondary	tmax	Time to reach maximum plasma concentration	predose and 1 min, 15 min, 30 min, 1 hour, 4 hours, and 8 hours postdose
Secondary	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
Secondary	Ae	Amount of manganese and zinc excreted into urine	4 hours post-dose and 24 hours post-dose
Secondary	Ae%	Percent of study drug manganese excreted into urine	4 hours and 24 hours post-dose