None listed
Conditions
Brief summary
Peripheral neuropathy is caused by damage to nerves. Current therapy needs to be improved as a significant proportion of neuropathic pain patients don’t respond to current therapy and these treatments have dose-limiting side effects. EMA401 is an angiotensin II type 2 (AT2) receptor antagonist, a class of molecules that offers an innovative approach to the treatment of neuropathic pain. EMA401 has shown efficacy in a number of relevant models and good human safety and pharmacokinetics in Phase 1 studies. This study will look at whether EMA401 reduces pain in patients who have peripheral neuropathy caused by cancer chemotherapy drugs, whether it has an effect on biomarkers of pain, and whether it is well tolerated.
Interventions
EMA401 100mg orally twice a day for 28 days
Sponsors
Spinifex Pharmaceuticals Pty Ltd
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Able to give voluntary written informed consent to participate in the study. 18 to 80 years old inclusive. Previously received taxane and/or platinum based chemotherapy for any type of cancer and are not expected to receive further chemotherapy for the study duration. Signs and symptoms of sensory peripheral neuropathy of the lower limbs which have been clinically stable for at least 8 weeks prior to Screening. History of spontaneous pain in the lower limbs for at least 8 weeks prior to Screening. Moderate to severe spontaneous neuropathic pain in the lower limbs. Female of non-child-bearing potential, or if of child-bearing potential, must have used adequate contraceptive precautions for 30 days prior to Screening, and must agree to use two approved methods of contraception for the duration of the study and for one month after administration of the last dose of study medication OR Are male and agree to use two approved methods of contraception for the duration of the study and until one month after administration of the last dose of the study medication. Able to read and understand English. Have a telephone.
Exclusion criteria
Pregnant or breast-feeding. Do not and cannot comply with the protocol concomitant medication restrictions. Participated in an investigational medical product study within the past 3 months prior to Day 1. Exposure to more than 3 new chemical entities within 12 months prior to Day 1. Previously received EMA401. Known to be allergic to EMA401 or any of the excipients. History or evidence of any other clinical neuropathy. Any other pain condition or injury that may confound the self-evaluation of pain due to peripheral neuropathy. History of clinically significant cardiac arrhythmias or the presence of clinically significant abnormalities on electrocardiogram (ECG) at screening. Resting supine blood pressure < 165/95mmHg. Resting pulse rate >100 or <50 beats per minute (bpm) on two consecutive measurements at least 10 minutes apart. Calculated creatinine clearance (using Cockroft and Gault formula) of less than 50 mL/min at Screening. Serum aspartate transaminase (AST), gamma glutamyl transaminase (GGT) or alanine transaminase (ALT) levels greater than 3.0 x the upper limit of normal or have total bilirubin concentrations greater than 2.0 x the upper limit of normal at Screening. History of or current hepatitis B (HBV), hepatitis C (HCV) or human immunodeficiency virus (HIV) infection. Other than the condition under study, have a history of or current active medical condition including allergic, skin, cardiovascular, psychiatric disease, drug or alcohol abuse, or laboratory finding, that in the opinion of the investigator precludes participation in the study, or may interfere with the study objectives / results. Pacemaker or implanted brain or cord stimulators.
Outcome results
None listed