Status:
WITHDRAWN
A Study of Safety and Tolerability of NOX66 in Healthy Volunteers
Lead Sponsor:
Noxopharm Limited
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
A Phase 1, double- blinded, randomised, placebo-controlled study to assess safety, tolerability and pharmacokinetics of 2 formulations of NOX66 in healthy subjects when administered over 4 cohorts as ...
Detailed Description
The study will be a single-centre study of NOX66 in two formulations administered once rectally and oral idronoxil . Approximately 50 subjects will be enrolled in 5 cohorts, comprising 1 oral dose (40...
Eligibility Criteria
Inclusion
- Provision of informed consent.
- Male and/or female subjects, 18 - 55 years of age.
- BMI of 17.5 to 30 kg/m2 and a total body weight \>50 kg.
- Negative hepatitis panel (including HBsAg and anti-HCV) and negative HIV antibody screens.
- Negative test for selected drugs of abuse.
- Males and females of childbearing potential who are not abstinent from heterosexual intercourse as part of their usual and preferred lifestyle must agree for the study duration and for 3 months after study to use two effective means of contraception (hormonal contraception, intrauterine device, condoms). Surgical sterilisation \>3 months prior to Screening is acceptable.
- Postmenopausal females should have menopause confirmed by follicle-stimulating hormone (FSH) testing.
- Subjects who have same sex partners or who practice abstinence in line with standard and preferred lifestyle will not be required to use contraception.
Exclusion
- Evidence or history of clinically significant hematological, 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).
- 12-lead ECG at screening or at first admission to the study center. Subjects with a QTcF interval \>450 msec or QRS interval ≥110 msec will be excluded.
- Treatment with an investigational drug /device within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study medication (whichever is longer).
- Other severe acute or chronic medical or psychiatric conditions or a laboratory 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.
- Abnormal nutritional status, including unconventional and abnormal dietary habits; excessive or unusual vitamin intake; malabsorption (oral cohort only).
- Has history of significant drug or alcohol abuse within past 5 years or has a positive drug screen.
- Smoking or use of nicotine-containing substances within past 2 months with the exception for social smokers who will be allowed a maximum of 5 cigarettes per week.
- Has use of any prescription or nonprescription medications or herbal supplements, except for paracetamol, within 14 days before the first dose of study drug, unless approved by the PI and sponsor.
- History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs except that appendectomy, cholecystectomy, and hernia repair will be allowed.
- Consumption of grapefruit/starfruit-containing foods and beverages or other CYP3A4 inhibitors or inducers for 72 hours prior to Screening and during the entire study.
- Donation of blood from 30 days prior to Screening through Study Completion/End of treatment (ET), inclusive, or plasma from 2 weeks prior to Screening through Study Completion/ET, inclusive.
- Any acute or chronic condition that, in the opinion of the Investigator, would limit the subject's ability to complete and/or participate in this clinical study.
- Use of alcohol within previous 24 hours or use of caffeine within previous 12 hours of Day -1 admission.
Key Trial Info
Start Date :
March 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2019
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03780465
Start Date
March 1 2019
End Date
March 1 2019
Last Update
May 28 2019
Active Locations (1)
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1
Nucleus Network Ltd
Melbourne, Victoria, Australia, 3004