A study to evaluate the safety, tolerability, pharmacokinetics and analgesic efficacy of oral CMX-020 in healthy male and female subjects.
- Conditions
- Chronic painOther - Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)
- Registration Number
- ACTRN12615000199516
- Lead Sponsor
- Cytometix Australia Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 30
if female of child bearing potential; must be surgically sterile, or practicing a medically acceptable form of contraception. Must have a negative urine pregnancy test at screening and check-in and be non-lactating.
- if male; must agree to use a condom if engaging in sexual intercourse at any time during the study.
- good health as determined by a physician.
- clinical lab results within reference range unless results are deemed not clinically significant by Investigator or Sponsor, or normal upon retesting during the screening and check-in periods.
- BMI between 21 and 30 kg/m2, inclusive.
- negative urine toxicology screen for substances of abuse and a negative alcohol breath screen during screening and check-in.
- negative for hepatitis B surface antigen, hepatitis C antibody and HIV at screening visit.
- creatinine clearance of at least 70 mL/min during screening.
- history of injury or disease involving either hand.
- history of drug or alcohol abuse within the past 2 years.
- previous history of cancer, other than basal cell or Stage 1 squamous cell carcinoma of the skin, that has not been in remission for at least 5 years prior to dose of study drug.
- systolic BP >140 mm Hg or < 85 mm Hg, or diastolic BP > 90 or < 60 mm of Hg at screening or check-in.
- pulse > 100 beats/minute or < 55 beats /minute during screening or check-in.
- medical history of hypertension, hypotension or postural hypotension.
- history of any acute or chronic painful condition requiring frequent analgesic use.
- pain at the time of check-in or morning of Day 1 which would warrant analgesia during the study or potentially interfere with pain assessments.
- history or family history of seizure.
- history of head trauma requiring an ER visit, inpatient observation or hospitalization.
- history of syncope.
- history or clinical manifestations of significant metabolic, hematologic, pulmonary, cardiovascular, gastrointestinal, neurologic, hepatic, renal, urologic, immunologic, or psychiatric disorders.
- clinically significant abnormal ECG at screening.
- history of long QT syndrome or a QTcF interval > 450 msec at screening.
- unwilling to abstain from grapefruit, grapefruit juice, or any caffeine-containing products or medications for 72 hours prior to study drug administration and throughout study.
- consumed alcohol within 72 hours prior to screening or baseline/check-in visits.
- used any tobacco products within 6 weeks prior to screening.
- dietary restrictionsand poor venous access.
- used any prescription, OTC, nutraceuticals, herbal or homeopathic medication or vitamins within 14 days prior to study drug administration.
- donated blood within 30 days prior to check-in visit.
- participated in an investigational study within past 30 days or 5 half lives of the investigational drug (whichever is longer) prior to study drug administration.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method