Clinical trial NCT02205554 (phase 1, status: completed)
Conditions: pain
ICD codes: N50.82, R07.2, R07.82, R10.13, R10.33, R14.1, R52
Drugs: omnitram, tramadol, placebo
SMILES: COC1=CC=CC(=C1)[C@@]1(O)CCCC[C@@H]1CN(C)C, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          1. Healthy male with normal vital signs: systolic blood pressure > 90 mm Hg and < 140 mm
             Hg; diastolic blood pressure > 50 mm Hg and < 90 mm Hg; pulse 50 to 100 beats per
             minute; respiratory rate 12 to 20 breathes per minute

          2. Between the ages of 21 and 55 years of age

          3. Able and willing to give informed consent

          4. Able to comply with all study procedures

          5. Have adequate hematologic function as evidenced by the following screening results:

               -  White Blood Cell (WBC) >3,500/mm3 and < 12,000/mm3;

               -  Platelet Count > 150,000/mm3 and < 540,000/mm3;

               -  Hemoglobin > 12.5 gm/dL and < 20.5 gm/dL.

             Have adequate liver function as evidenced by the following screening results:

               -  Aspartate transaminase (AST) ≤ 60 IU/L;

               -  Alanine transaminase (ALT) ≤ 83 IU;

               -  Alkaline Phosphatase ≤ 150 IU/L;

               -  Total Bilirubin ≤ 1.2 mg/dL;

               -  Prothrombin Time (PT) < 1.2 upper limit of normal (ULN); Partial Thromboplastin
                  Time (PTT) < 1.2 ULN.

          6. Electrocardiogram (ECG) within normal limits as determined by the PI

          7. Have adequate renal function as evidenced by the following screening result:

             Glomerular filtration rate (GFR) calculated by Cockcroft-Gault formula >60 ml/min.

             Urinalysis demonstrating < +1 glucose, +1 ketones, and +1 protein

          8. Negative urine test for substances of abuse, including opiates, per clinical research
             unit (CRU) standards

          9. Negative serology tests for HIV, hepatitis B surface antigen and hepatitis C virus
             antibody

         10. Body Mass Index (BMI) 19.0 to 32 kg/m

         11. Cold pressor screening results as follows: 1) pain tolerance of > 20 seconds and <120
             seconds

        Exclusion Criteria:

          1. Oral temperature > 38°C or history of current illness

          2. History of seizures, epilepsy, or recognized increase risk of seizure (e.g., head
             trauma, metabolic disorders, alcohol or drug withdrawal)

          3. History of cirrhosis or laboratory evidence of liver disease

          4. Use of alcohol within 24 hours of day -1 until the end of the study; and grapefruit,
             grapefruit-related citrus fruits (e.g., Seville oranges, pomelos), or grapefruit juice
             or grapefruit-related juices, or other medication, within 7 days of study drug
             administration and until the end of the study

          5. History of previous anaphylaxis, severe allergic reaction to Tramadol, codeine, or
             other opioid drugs

          6. Use of monoamine oxidase (MAO) inhibitors (including linezolid), Serotonin Reuptake
             Inhibitors, Serotonin-Norepinephrine Reuptake Inhibitors, and prescription or over-the
             counter (OTC) medications known to induce or inhibit drug metabolism, including
             cytochrome P450 2D6 (CYP2D6), and other drugs that may affect the serotonergic
             neurotransmitter systems including, but not limited to, triptans, dextromethorphan,
             tricyclic antidepressants, bupropion, lithium, tramadol, dietary supplements such as
             tryptophan and St. John's Wort, and antipsychotics or other dopamine antagonists.
             These restrictions are to be maintained from 14 days before study day -1, until the
             subject completes the study

          7. Any other unstable acute or chronic disease that could interfere with the evaluation
             of the safety of the study drug as determined by the principal Investigator in
             dialogue with the Sponsor Medical Monitor

          8. Unlikely to comply with the study protocol

          9. Known or suspected alcohol or drug abuse within the past 6 months

         10. Received another investigational agent within 4 weeks of Day 0, or within five
             half-lives of Day 0, whichever is longer; or receiving any other investigational agent
             during this study

         11. Any concurrent disease or condition that in the opinion of the investigator impairs
             the subject's ability to complete the trial. Psychological, familial, sociological,
             geographical or medical conditions which, in the Investigator's opinion, could
             compromise compliance with the objectives and procedures of this protocol, or obscure
             interpretation of the trial data