Status:
COMPLETED
Omnitram Pharmacokinetic and Analgesic Study Following CY2D6 Inhibition With Paroxetine In Healthy Volunteers
Lead Sponsor:
Syntrix Biosystems, Inc.
Collaborating Sponsors:
PRA Health Sciences
DF/Net Rearch
Conditions:
Pain
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
This study evaluates the analgesic effect of Omnitram and tramadol during concurrent administration of paroxetine. Paroxetine administration is expected to diminish the analgesic effect of tramadol, b...
Detailed Description
A randomized, double-blind, placebo-controlled study to investigating the steady-state oral pharmacokinetics and hypoalgesic effects of overencapsulated: 20 mg Omnitram (2x10 mg tablets), 50 mg tramad...
Eligibility Criteria
Inclusion
- Healthy males and females with normal vital signs: systolic blood pressure \> 90 mm Hg and \< 140 mm Hg; diastolic blood pressure \> 45 mm Hg and \< 90 mm Hg; pulse 40 to 100 beats per minute; respiratory rate 10 to 20 breathes per minute.
- Between the ages of 18 and 50 years of age.
- Able and willing to give informed consent
- Able to comply with all study procedures.
- If female, must not be of childbearing potential or must agree to use one or more of the following forms of contraception during screening and for 30 days following study drug administration: hormonal (e.g., oral, transdermal, intravaginal, implant or injection); double barrier (i.e., condom, diaphragm with spermicide); intrauterine device (IUD) or system (IUS); vasectomized partner (6 months minimum); abstinence; or bilateral tubal ligation.
- Have adequate hematologic function as evidenced by the following screening results:
- WBC \>3,500/mm3 and \< 12,000/mm3 Platelet Count \> 150,000/mm3 and \< 540,000/mm3 Hemoglobin \> 12.0 gm/dL and \< 20.5 gm/dL
- Have adequate liver function as evidenced by the following screening results:
- AST (SGOT) ≤ 60 IU/L ALT (SGPT) men ≤ 83 IU/L women \< 60 IU/L Alkaline Phosphatase ≤ 200 IU/L Total Bilirubin ≤ 1.2 mg/dL PT and PTT \< 1.2 ULN
- Electrocardiogram (ECG) without clinically significant findings 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 pregnancy test within 1 week of study day 1 (women of childbearing potential only).
- Negative urine test for substances of abuse, including opiates, per CRU standards.
- Negative serology tests for HIV, hepatitis B surface antigen, and hepatitis C virus antibody.
- Body Mass Index (BMI) 18.0 to 32 kg/m.
- Cold pressor screening results as follows: 1) pain tolerance of \> 20 seconds and \<120 seconds.
- Cytochrome P450 2D6 (CYP2D6) genotype by Genelex consistent with intermediate metabolizer phenotype or normal metabolizer phenotype.
Exclusion
- 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 paroxetine, tramadol, codeine, or other opioid drugs.
- Use of 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 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.
- Currently pregnant or breast feeding.
- 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 1, 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.
Key Trial Info
Start Date :
October 31 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 22 2017
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03312777
Start Date
October 31 2017
End Date
December 22 2017
Last Update
December 28 2017
Active Locations (1)
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1
PRA Health Sciences
Salt Lake City, Utah, United States, 84124