Major Depressive Disorder Clinical Trial
— CX157-112Official title:
A Phase I, Multiple-Dose, Randomized, Double-Blind, Oral Tyramine Pressor Response Study Comparing CX157 Tablets to Placebo in Healthy Male Volunteers
Verified date | June 2012 |
Source | CeNeRx BioPharma Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The objectives of this study were to examine the cardiovascular sensitivity to oral tyramine after establishment of steady state with CX157 Modified Release (MR) Tablets, 125 mg administered twice per day (BID) in healthy volunteers compared to placebo; and to investigate the general safety, tolerability and pharmacokinetic profile of CX157 tablets at steady state compared to placebo.
Status | Completed |
Enrollment | 12 |
Est. completion date | October 2010 |
Est. primary completion date | October 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 50 Years |
Eligibility |
Inclusion Criteria: 1. Male between 18 to 50 years of age, inclusive. 2. In good general health as ascertained by not clinically significant physical examination (PE) including measurement of vital signs, medical history, clinical laboratory studies, and 12-lead electrocardiogram (ECG). 3. Body Mass Index (BMI) =22 and =30 kg/m2. 4. Agree to abstain from consuming either alcohol-containing or caffeine-containing beverages and to adhere to the dietary restrictions. Exclusion Criteria: 1. Presence of a significant acute or chronic medical disorder. 2. The mean of three consecutive semi-recumbent SBP and diastolic blood pressure (DBP) readings taken five minutes apart over a 10-minute period at Screening and Day -1 exceeds 140 mmHg and 90 mmHg, respectively, and/or is not stable (semi-recumbent SBP exceeds a maximum range of 10 mmHg between the lowest and highest value). 3. The mean of three consecutive semi-recumbent SBP and DBP readings taken five minutes apart over a 10-minute period at Screening and Day -1 is <90 mmHg and 60 mmHg, respectively. 4. Has the requirement for or use of any prescription medications within 35 days of study initiation or anticipates use of any psychoactive medication during the study. 5. Has taken an monoamine oxidase inhibitor (MAOI) within 90 days preceding Period 1, Day 1 of the study. 6. Has requirement for any medication contraindicated for use with an MAOI. 7. Use of any over-the-counter (OTC) medication within 14 days of study drug. 8. History of substance abuse or dependence, including alcohol abuse as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria, within the past 12 months. 9. Use of tobacco products or any nicotine-containing products (e.g., gum, patch) currently or within the prior 6 months. 10. Subject is unwilling to stop consumption of alcohol or caffeine/xanthine-containing drinks or foods within 72 hours of dosing of Day 1 (including any type of wines, caffeinated or decaffeinated herbal tea, grapefruit products (e.g., fresh, canned, or frozen), Seville oranges and pomelos). 11. Subjects with known adverse events associated with ingestion of tyramine-containing food. 12. Subjects with contraindications to administration of adrenergic receptor antagonists such as labetalol (e.g., asthma, obstructive airway disease, severe bradycardia, diabetes). 13. Abnormal screening medical/physical examination, unless the abnormality is considered unlikely to be affected by study participation, or to confound interpretation of safety data. 14. A clinically significant clinical laboratory or ECG abnormality at screening; includes any of the following: 1. Aspartate aminotransferase (AST/SGOT) >2.0 x the upper limit of normal (ULN), 2. Alanine aminotransferase (ALT/SGPT) >2.0 x the ULN, 3. Alkaline phosphatase (ALP) >2.0 x the ULN, 4. Total bilirubin >1.5 x the ULN, 5. Serum creatinine >1.5 x the ULN, and 6. Blood urea nitrogen (BUN) >1.5 x the ULN. 15. Anticipates elective surgery requiring general anesthesia for at least 10 days following the end of study. 16. Test positive for: Cannabinoids, cocaine, amphetamines, barbiturates, opiates or benzodiazepines, cotinine, alcohol use, hepatitis B or C, or human immunodeficiency virus (HIV). 17. Participation in a clinical investigation within the last 60 days. 18. Previous participation in a prior study of CX157. 19. Any other condition which, in the investigator's opinion, may place the subject at greater than normal risk of developing complications. 20. Donated any blood product (one pint or greater) within the previous 8 weeks. 21. Planning to donate any blood product within 8 weeks of end of study. |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Comprehensive Phase One | Miramar | Florida |
Lead Sponsor | Collaborator |
---|---|
CeNeRx BioPharma Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Systolic Blood Pressure (SBP) | SBP was measured every 5 minutes for the first two hours and every 15 minutes for the next two hours post tyramine ingestion on study Days 10 (20 mg tyramine), 11 (40 mg tyramine), and 12 (80 mg tyramine). | 4 hours post dose on study Days 10, 11, 12 | Yes |
Secondary | Number of subjects with adverse events as a measure of safety and tolerability of CX157. | Adverse events were collected during the study. | Study Days 4-12 (during the DB study drug administration) | Yes |
Secondary | Cmax, Cmin, Tmax | The full pharmacokinetic (PK) profile was obtained after the morning dose on Day 9. In addition, trough blood samples were obtained before the morning and evening doses on study Days 6, 7, and 8; and before the morning dose on Days 10, 11 and 12. | Study Days 6-12 | No |
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