Chemotherapy Induced Peripheral Neuropathy (CIPN)
Conditions
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.
Interventions
DRUGCalmangafodipir
Single ascending doses of 2 μmol/kg, 5 μmol/kg, and 10 μmol/kg
DRUGPlacebo
Placebo
Sponsors
Egetis Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Double-blind
Eligibility
Sex/Gender
MALE
Age
20 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of treatment-emergent adverse events | 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
| Measure | Time frame | Description |
|---|---|---|
| Cmax | predose and 1 min, 15 min, 30 min, 1 hour, 4 hours, and 8 hours postdose | Maximum plasma concentration during a dosing interval |
| tmax | predose and 1 min, 15 min, 30 min, 1 hour, 4 hours, and 8 hours postdose | Time to reach maximum plasma concentration |
| AUC(0-last) | 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 |
| Ae | 4 hours post-dose and 24 hours post-dose | Amount of manganese and zinc excreted into urine |
| Ae% | 4 hours and 24 hours post-dose | Percent of study drug manganese excreted into urine |
Countries
United States
Outcome results
None listed