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Omnitram Pharmacokinetic Study In Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT02205554
Recruitment Status : Completed
First Posted : July 31, 2014
Last Update Posted : October 15, 2014
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Syntrix Biosystems, Inc.

Brief Summary:
The purpose of this study is to compare the safety, pharmacokinetic properties (the absorption, distribution and excretion), and analgesic activity of Omnitram (10 mg tablets), Tramadol (Ultram, 50 mg tablet) following oral administration of 9 doses healthy subjects.

Condition or disease Intervention/treatment Phase
Pain Drug: Omnitram Drug: Tramadol Drug: Placebo Phase 1

Detailed Description:

A Phase 1, single-center, randomized, double-blind, placebo-controlled, three-period cross-over study to compare the safety, steady-state oral pharmacokinetics, and clinical activity of overencapsulated: 20 mg Omnitram (2x10 mg tablets), 50 mg Tramadol (1x50 mg Ultram tablet), and placebo.

Forty male subjects in normal health, 21 to 55 years of age, will be randomized to three parallel arms (N=~13 each) to ingest a total of 9 doses of Omnitram, Tramadol, or placebo in a first treatment segment (one dose every 6 hours). Around the 9th dose blood samples are collected to quantify plasma Tramadol and Metabolite 1 (M1) enantiomers. After the 9th dose, pain tolerance is assessed with a cold pressor test (ice cold water immersion). After the 7th dose abuse liability measures and pupil diameter will be assessed. Subjects will washout for 7 days after the first treatment segment and second treatment segment.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 1 Randomized, Double-Blind, Placebo-Controlled, Triple Cross-Over Study Investigating The Safety, Oral Steady-State Pharmacokinetics, And Clinical Activity Of 20 Mg Omnitram And 50 Mg Tramadol In Normal Human Subjects
Study Start Date : August 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Tramadol

Arm Intervention/treatment
Active Comparator: Omnitram-Tramadol-Placebo
Omnitram 20 mg every 6 hours for 9 doses, followed by Tramadol 50 mg every 6 hours for 9 doses, followed by Placebo every 6 hours for 9 doses.
Drug: Omnitram
Nine 20 mg doses administered every 6 hours

Drug: Tramadol
Nine 50 mg doses administered every 6 hours.

Drug: Placebo
Nine doses administered every 6 hours.

Active Comparator: Tramadol-Placebo-Omnitram
Tramadol 20 mg every 6 hours for 9 doses, followed by Placebo every 6 hours for 9 doses, followed by Omnitram 20 mg every 6 hours for 9 doses.
Drug: Omnitram
Nine 20 mg doses administered every 6 hours

Drug: Tramadol
Nine 50 mg doses administered every 6 hours.

Drug: Placebo
Nine doses administered every 6 hours.

Active Comparator: Placebo-Omnitram-Tramadol
Placebo every 6 hours for 9 doses, followed by Omnitram 20 mg every 6 hours for 9 doses, followed by Tramadol 50 mg every 6 hours for 9 doses.
Drug: Omnitram
Nine 20 mg doses administered every 6 hours

Drug: Tramadol
Nine 50 mg doses administered every 6 hours.

Drug: Placebo
Nine doses administered every 6 hours.




Primary Outcome Measures :
  1. Omnitram and Tramadol Steady State Maximum and Minimum Concentrations [ Time Frame: 0.0, 1.0, 1.5, 2.0, 2.5, and 4.0 hours after the 9th dose of Omnitram and Tramadol. ]
  2. Adverse events [ Time Frame: 29 days ]

Secondary Outcome Measures :
  1. Cold Water Induced-Pain Reported On a 0 to 10 Scale [ Time Frame: On Study Day 2, Study Day 12, and Study Day 22, after the 9th dose of Omnitram, Tramadol, and placebo. ]
    Subject immerses a hand in cold water for a maximum of 3 minutes and reports level of pain.

  2. Abuse Liability Assessed With Visual Analogue Scales [ Time Frame: On Study Day 1, Study Day 11, and Study Day 21, after the 7th dose of Omnitram, Tramadol, and placebo. ]
    Subjects read a question and respond by placing a mark on a visual analogue scale.


Other Outcome Measures:
  1. Pupil Size [ Time Frame: On Study Day 1, Study Day 11, and Study Day 21, after the 7th dose of Omnitram, Tramadol, and placebo. ]
    A pupilometer is used to measure eye pupil size.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02205554


Locations
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United States, Utah
CRI Lifetree Research Center
Salt Lake City, Utah, United States, 84106
Sponsors and Collaborators
Syntrix Biosystems, Inc.
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Shawn Searle, MD PRA/CRI Lifetree Research Center
Study Director: Stuart Kahn, MD Syntrix Biosystems, Inc.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Syntrix Biosystems, Inc.
ClinicalTrials.gov Identifier: NCT02205554    
Other Study ID Numbers: Syntrix-Omni-Pain-101
R44DA027304 ( U.S. NIH Grant/Contract )
First Posted: July 31, 2014    Key Record Dates
Last Update Posted: October 15, 2014
Last Verified: October 2014
Keywords provided by Syntrix Biosystems, Inc.:
Analgesia
Pharmacokinetics
Treatment
Additional relevant MeSH terms:
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Tramadol
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents