A Randomized Study Investigating Oral Desmetramadol Dose Proportionality and Food Effect In Normal Human Subjects
Condition: Pain
Intervention: Desmetramadol
Intervention description: Analgesic
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: An open-label, randomized, balanced, single-dose, four-treatment, four-period, four-sequence (using a Williams' square design) cross-over study.
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 19 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Pharmacokinetics; Food effect

Summary:

      The purpose of the study is to investigate in healthy human subjects how much desmetramadol
      (Omnitram) gets in the blood after different oral doses are taken with or without food.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Healthy males and females with vital signs as follows at screening: systolic blood
             pressure > 90 mm Hg and < 140 mm Hg; diastolic blood pressure > 40 mm Hg and < 90 mm
             Hg; pulse 40 to 99 beats per minute; respiratory rate 12 to 24 breathes per minute.

          2. Age 19 to 55 years.

          3. Able and willing to give informed consent

          4. Able to comply with all study procedures.

          5. If female, must not be of childbearing potential or must agree to use one or more of
             the following forms of contraception from screening, throughout the study and for 30
             days following study drug administration: hormonal (e.g., oral, transdermal,
             intravaginal, implant or injection for 3 months); double barrier (e.g., condom or
             diaphragm with spermicide); intrauterine device (IUD) or system (IUS) (for 3 months);
             vasectomized partner (6 months minimum); or abstinence.

             Screening laboratory results must be within normal range per clinical research unit:
             serum sodium, potassium, calcium, BUN, creatinine, ALT, AST, total bilirubin, alkaline
             phosphatase, glucose (random), albumin, total protein, WBC and differential,
             hemoglobin, and platelets. In addition PT and PTT must be < 1.2 ULN.

          6. Electrocardiogram (ECG) without clinically significant abnormalities.

             Urinalysis demonstrating < +1 glucose, and +1 protein.

          7. If female, must have a negative pregnancy test at screening

          8. Negative urine test for substances of abuse, including opiates, per clinical
             pharmacology unit standards at screening and clinic check-in.

          9. Negative serology tests for HIV, hepatitis B surface antigen, and hepatitis C virus
             antibody.

         10. Weight > 50 Kg and a body mass index (BMI) of 18.0 to 32.0 kg/m (inclusive).

         11. Non-smoker of tobacco for a minimum of the past 3 months, and negative urine continine
             test.

        Exclusion Criteria:

          1. Oral temperature > 38°C or 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. Having undergone gall bladder removal.

          5. 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 within 7 days of study drug administration and until the
             end of the study.

          6. History of previous anaphylaxis, severe allergic reaction to tramadol, codeine, or
             other opioid drugs.

          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. Females must not be currently pregnant or breast feeding.

          9. Unlikely to comply with the study protocol.

         10. Known or suspected alcohol or drug abuse within the past 6 months.

         11. Received another investigational agent within 4 weeks of Day -1, or within five
             half-lives of Day -1, whichever is longer; or receiving any other investigational
             agent during this study.

         12. 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.