- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02205554
Omnitram Pharmacokinetic Study In Healthy Volunteers
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Utah
-
Salt Lake City, Utah, United States, 84106
- CRI Lifetree Research Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
- Between the ages of 21 and 55 years of age
- Able and willing to give informed consent
- Able to comply with all study procedures
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.
- Electrocardiogram (ECG) within normal limits as determined by the PI
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
- Negative urine test for substances of abuse, including opiates, per clinical research unit (CRU) standards
- Negative serology tests for HIV, hepatitis B surface antigen and hepatitis C virus antibody
- Body Mass Index (BMI) 19.0 to 32 kg/m
- Cold pressor screening results as follows: 1) pain tolerance of > 20 seconds and <120 seconds
Exclusion Criteria:
- Oral temperature > 38°C or history of current illness
- History of seizures, epilepsy, or recognized increase risk of seizure (e.g., head trauma, metabolic disorders, alcohol or drug withdrawal)
- History of cirrhosis or laboratory evidence of liver disease
- 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
- History of previous anaphylaxis, severe allergic reaction to Tramadol, codeine, or other opioid drugs
- 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
- 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
- Unlikely to comply with the study protocol
- Known or suspected alcohol or drug abuse within the past 6 months
- 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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / 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.
|
Nine 20 mg doses administered every 6 hours
Nine 50 mg doses administered every 6 hours.
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.
|
Nine 20 mg doses administered every 6 hours
Nine 50 mg doses administered every 6 hours.
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.
|
Nine 20 mg doses administered every 6 hours
Nine 50 mg doses administered every 6 hours.
Nine doses administered every 6 hours.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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.
|
0.0, 1.0, 1.5, 2.0, 2.5, and 4.0 hours after the 9th dose of Omnitram and Tramadol.
|
Adverse events
Time Frame: 29 days
|
29 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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On Study Day 2, Study Day 12, and Study Day 22, after the 9th dose of Omnitram, Tramadol, and placebo.
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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.
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Subjects read a question and respond by placing a mark on a visual analogue scale.
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On Study Day 1, Study Day 11, and Study Day 21, after the 7th dose of Omnitram, Tramadol, and placebo.
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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On Study Day 1, Study Day 11, and Study Day 21, after the 7th dose of Omnitram, Tramadol, and placebo.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Shawn Searle, MD, PRA/CRI Lifetree Research Center
- Study Director: Stuart Kahn, MD, Syntrix Biosystems, Inc.
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Syntrix-Omni-Pain-101
- R44DA027304 (NIH)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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