Status:
UNKNOWN
Pharmacokinetic Study of CXB909 in Healthy Male Subjects
Lead Sponsor:
CeNeRx BioPharma Inc.
Conditions:
Healthy
Eligibility:
MALE
18-50 years
Phase:
PHASE1
PHASE2
Brief Summary
The primary objective of this dose escalation study is to examine the safety, tolerability, and pharmacokinetic properties of single-doses of CXB909, compared to placebo, in healthy male volunteers. T...
Eligibility Criteria
Inclusion
- Male, 18 to 50 years of age.
- Able to read, understand, and provide written/dated informed consent before screening in the study, and must be willing to comply with all study procedures.
- In good general health as ascertained by thorough medical history, physical examination (PE)including measurement of supine and standing vital signs, clinical laboratory studies, and 12-lead electrocardiogram (EKG).
- Body Mass Index (BMI) \> 21 and \< 30.
- Willing and able to be confined to the clinical research unit as required by the protocol.
Exclusion
- Presence of a significant acute or chronic medical disorder that might complicate evaluation of the study drug such as:
- Any cardiovascular or cardiac condition.
- Supine SBP≥145 mmHg and/or DBP ≥90 mmHg at Screening.
- Diabetes mellitus.
- Malignancy and/or chemotherapy within two years of screening, other than basal cell carcinoma. Malignancies more than two years prior may not preclude participation; however, must be reviewed on a case-by-case basis by the CeNeRx BioPharma, Inc., medical monitor.
- Known or suspected hypersensitivity to CXB909.
- Any gastrointestinal disease or digestive disorder, neurological, pulmonary, hepatic, renal, hematologic, endocrine and/or metabolic disease or disorder.
- Current or past psychiatric illness.
- Use of any prescription medications within 14 days of study drug administration.
- Use of any over-the-counter (OTC) medication within seven days of study drug administration (including herbal remedies).
- History of substance abuse, including alcohol abuse as defined by DSM-IV criteria,within the past 12 months.
- Current use of tobacco products or any nicotine-containing products (e.g., gum, patch)for the prior three months.
- Consumption of alcohol or caffeine/xanthine-containing drinks or foods within 72 hours of dosing on Day 1 (including any type of wines, caffeinated or decaffeinated herbal tea, and grapefruit products (e.g., fresh, canned, or frozen), Seville oranges and pomelos).
- Abnormal screening medical/physical examination, unless the abnormality is considered unlikely to be affected by study participation, or confound interpretation of safety data.
- A clinically significant clinical laboratory or EKG abnormality at screening; includes any of the following: aspartate transaminase (AST), alanine transaminase (ALT), or alkaline phosphate (ALP) \>2.0 x the upper limit of normal (ULN); total bilirubin \>1.5 x the ULN;serum creatinine \>1.5 x the ULN; blood urea nitrogen (BUN) \>1.5 x the ULN; and thyroid stimulating hormone (TSH) and/or free thyroxine (T4) outside of the normal limits.
- Test positive for: Urine cannabinoids, cocaine, amphetamines, barbiturates, opiates or benzodiazepines, serum alcohol, hepatitis B or C, or nicotine use.
- HIV/AIDS.
- Participation in a clinical investigation within the last 45 days of screening.
- Any other condition which, in the investigator's opinion, may place the subject at greater than normal risk of developing complications.
- Donation of any blood product (one pint or greater) within the previous eight weeks of screening.
- Planning to donate any blood product within eight weeks of end of study.
Key Trial Info
Start Date :
December 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2014
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01505907
Start Date
December 1 2012
End Date
December 1 2014
Last Update
January 9 2012
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.