None listed
Conditions
Brief summary
The purpose of this study is to test the safety and absorption of a new formulation of a drug called NOX66. Who is it for? You may be eligible for this study if you are aged 18 to 50, and in generally good health. Study details All participants will be administered two doses of the study drug with a week between doses. The study drug is administered as a suppository (inserted into the rectum). As part of the study, participants will provide blood, urine and stool samples; and wear a heart monitor on their chest. It is hoped this research will provide some baseline information about how this new formulation of NOX66 is metabolised by the body, and show the medication is safe in this form.
Interventions
The study drug (NOX66) is formulated in a single use suppository with a proprietary lipophilic base containing 400 or 600 mg of idronoxil. This open-label, replicate, Phase 1 study will evaluate the safety/tolerability of single doses of NOX66 administered rectally at a single centre.
Approximately 24 subjects will be enrolled in 2 dose cohorts. Cohort 1 will receive NOX66 400 mg and cohort 2 will be dose escalated to receive 600 mg. Each dose will be given twice, separated by at least 7 days
The study drug (NOX66) is formulated in a single use suppository with a proprietary lipophilic base containing 400 or 600 mg of idronoxil. This open-label, replicate, Phase 1 study will evaluate the safety/tolerability of single doses of NOX66 administered rectally at a single centre. Approximately 24 subjects will be enrolled in 2 dose cohorts. Cohort 1 will receive NOX66 400 mg and cohort 2 will be dose escalated to receive 600 mg. Each dose will be given twice, separated by at least 7 days.
Sponsors
Noxopharm Limited
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
1. Provision of informed consent. 2. Healthy male and female subjects, 18 - 50 years of age inclusive. 3. BMI of 17.5 to 30.0 kg/m2 and a total body weight >50 kg. 4. Good health as determined at Screening and Check-in by examining medical history (Screening only) and performing physical examinations, vital signs, ECGs, serum chemistry including liver function test, haematology, coagulation tests, and urinalysis. Laboratory test maybe repeated once at the discretion of the investigator. 5. Negative test result for human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), and hepatitis C virus (HCV) antibody at Screening. 6. Negative urine test for drugs of abuse (opiates, benzodiazepines, amphetamines, cannabinoids, cocaine, barbiturates, and phencyclidine), and breath alcohol at Screening and Check-in for both treatment periods. Tests at Screening maybe repeated once at the discretion of the investigator. 7. Negative urine pregnancy test at Screening and during Check-in (both treatment periods for all female subjects). 8. Females must be of nonchildbearing potential, non-lactating and be: • Surgically sterile (i.e., bilateral tubal ligation or removal of both ovaries and/or uterus at least 6 months prior to dosing OR • Naturally postmenopausal (spontaneous cessation of menses) for at least 12 consecutive months prior to dosing, confirmed with a Screening serum follicle-stimulating hormone level > 40 mIU/mL. 9. Males with partners who are females of childbearing potential must agree to use condoms and their female partner must also use contraception (e.g., hormonal or intrauterine device). The double contraception must be used from the first dose of study drug until at least 90 days following the last dose of study drug. Male subjects are required to refrain from sperm donation during the study and for at least 90 days following the last dose of study drug. • Male subjects who identify as abstinent must agree to adhere to contraception restrictions as outlined above should they become sexually active with female partners during the specified time frame. Male subjects who are exclusively in same sex relationships (as part of their preferred and usual lifestyle) are not required to use contraception. Willingness to refrain from consuming food or beverages containing caffeine/xanthine or alcohol for 48 hours prior to Check-in on Day -2 at each treatment period. 10. Willingness to refrain from consuming grapefruit/grapefruit juice and Seville oranges 7 days before the first dose of study drug on Day 1 until the end of the study. 11. Have regular bowel movements (e.g. once daily) 12. Must be able to eat a soya free diet for approximately 2 weeks.
Exclusion criteria
1.Evidence or history of clinically significant haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated asymptomatic, penicillin, seasonal allergies at the time of dosing) in the last 5 years or any disorder that prevent the successful completion of the study. 2. History of or presence of anorectal abnormalities that would potentially alter absorption of rectally administered drugs (except for hemorrhoids). 3. History or presence of an abnormal ECG, which, in the investigator’s opinion, is clinically significant and/or a corrected QT interval using Fridericia’s formula (QTcF) greater or equal to 450 msec for males and greater or equal to 470 msec for females or QRS interval greater or equal to 110 msec at Screening. 4. Echocardiogram findings not within normal limits and/or ejection fraction <50% at Screening. 5. Renal Function (using the Cockcroft-Gault equation) < 90 mL/min at Screening. 6. Diagnosis of Gilbert’s syndrome 7. Other severe acute or chronic medical conditions or a clinical laboratory test abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgement of the Principal Investigator (PI), would make the subject inappropriate for entry into this study. 8. Use of any prescription medications including those medication/products known to induce or inhibit Cytochrome p450 (CYP) and Uridine 5'-diphospho- glucuronosyltransferase (UGT) within 28 days from the first dose and during the study. 9. Use of over the counter (OTC), non-prescription medication (including vitamin D preparations and calcium) within 7 days from the first dose and during the study (excluding paracetamol (= 2 g/d). unless approved by the PI and Sponsor 10. Use of supplements (including phytotherapeutic/herbal/plant-derived preparations, vitamins and minerals) within 7 days from the first dose and during the study. 11. Treatment with an investigational drug /device within 30 days or 5 half-lives preceding 12. Use of nicotine-containing substances within past 2 months or a positive cotinine test at screening and Check-in (both periods). 13. Blood donation of 500 mL or more or a significant loss of blood within 56 days prior to the first dose of study drug and during the study. 14. Receipt of a transfusion or any blood products within 30 days prior to the first dose of study drug. 15. Consumption of more than 21 units of alcohol per week (males) or 14 units of alcohol per week (females), where 1 unit of alcohol equals 1/2 pint of beer, 150 mL of wine, or 30 mL of spirits, or significant history of alcoholism or drug/chemical abuse within the last 2 years. 16. Consumption of alcohol within 48 hours prior to Check-in and during the entire study.
Outcome results
None listed