None listed
Conditions
Brief summary
This is a Phase I, randomized, double-blind, analytically masked, placebo-controlled, sequential-panel, ascending single-dose, and repeated twice daily-dose, single-center study to evaluate the safety, tolerability, pharmacokinetics and antinociceptive effects of escalating single and multiple doses of CMX-020 administered orally to healthy male and female subjects.
Interventions
The interventional product, CMX-020, will be administered as an oral capsule.
CMX-020 and matching placebo will be provided as 10 mg capsules. Depending on the dose level, subjects will take 5, 10 or 20 capsules to provide 50 mg, 100 mg and 200 mg per dose.
The starting dose of 50 mg oral CMX-020 for the present study is consistent with the Maximum Recommended Starting Dose (MRSD) proposed in the Food and Drug Administration Guidance, 2005. The 50 mg starting dose is well within the 1/10th of
The interventional product, CMX-020, will be administered as an oral capsule. CMX-020 and matching placebo will be provided as 10 mg capsules. Depending on the dose level, subjects will take 5, 10 or 20 capsules to provide 50 mg, 100 mg and 200 mg per dose. The starting dose of 50 mg oral CMX-020 for the present study is consistent with the Maximum Recommended Starting Dose (MRSD) proposed in the Food and Drug Administration Guidance, 2005. The 50 mg starting dose is well within the 1/10th of the NOAEL safety margin established in the 14-day repeat dose study in monkey. Subsequent treatment groups (100 mg and 200 mg) will be dosed in an escalating order, each dose level increased by no more than 2-fold over the previous dose level. Subjects will be administered a single oral dose of CMX-020/placebo on Day 1 (fasted dose) and then a single oral dose of CMX-020/placebo on Day 8 (fed dose), followed by twice daily dosing of oral CMX-020/placebo from morning of Day 9 (fasted) through to morning of Day 13 (fasted) i.e. from Day 9 to Day 13, the subject will be administered 2 X 50mg doses per day for Cohort 1, 2 X 100mg doses per day for Cohort 2 and 2 X 200mg doses per day for Cohort 3. Every effort will be made to administer each dose of CMX-020 or matching placebo with 240 mL of room temperature water, particularly with the 0, 168 and 288 hour (PK) doses. If absolutely necessary, an additional amount of up to 240 mL of water may be taken to facilitate capsule ingestion and any additional amount recorded in the CRF. All medications will be administered in the clinical study unit under the supervision of study staff. Research personnel will ensure each study drug dose has been ingested by performing a hand and mouth check.
Sponsors
Cytometix Australia Pty Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver)
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Outcome results
None listed