Omnitram Pharmacokinetic Study In Healthy Volunteers

NCT02205554 | Completed Phase 1

• 2 other identifiers: Syntrix-Omni-Pain-101R44DA027304
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

Analgesia; Pharmacokinetics; Treatment

Outcome Measures

Primary Outcomes (2)

• Omnitram and Tramadol Steady State Maximum and Minimum Concentrations

  0.0, 1.0, 1.5, 2.0, 2.5, and 4.0 hours after the 9th dose of Omnitram and Tramadol.

• Adverse events

  29 days

Secondary Outcomes (2)

• Cold Water Induced-Pain Reported On a 0 to 10 Scale

  On Study Day 2, Study Day 12, and Study Day 22, after the 9th dose of Omnitram, Tramadol, and placebo.

• Abuse Liability Assessed With Visual Analogue Scales

  On Study Day 1, Study Day 11, and Study Day 21, after the 7th dose of Omnitram, Tramadol, and placebo.

Other Outcomes (1)

• Pupil Size

  On Study Day 1, Study Day 11, and Study Day 21, after the 7th dose of Omnitram, Tramadol, and placebo.

Study Arms (3)

Omnitram-Tramadol-Placebo

ACTIVE COMPARATOR

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; Drug: Tramadol; Drug: Placebo

Tramadol-Placebo-Omnitram

ACTIVE COMPARATOR

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; Drug: Tramadol; Drug: Placebo

Placebo-Omnitram-Tramadol

ACTIVE COMPARATOR

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; Drug: Tramadol; Drug: Placebo

Interventions

Omnitram DRUG

Nine 20 mg doses administered every 6 hours

Omnitram-Tramadol-Placebo; Placebo-Omnitram-Tramadol; Tramadol-Placebo-Omnitram

Tramadol DRUG

Nine 50 mg doses administered every 6 hours.

Omnitram-Tramadol-Placebo; Placebo-Omnitram-Tramadol; Tramadol-Placebo-Omnitram

Placebo DRUG

Nine doses administered every 6 hours.

Omnitram-Tramadol-Placebo; Placebo-Omnitram-Tramadol; Tramadol-Placebo-Omnitram

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Syntrix Biosystems, Inc.: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

CRI Lifetree Research Center

Salt Lake City, Utah, 84106, United States

Location

Related Publications (1)

• Zebala JA, Searle SL, Webster LR, Johnson MS, Schuler AD, Maeda DY, Kahn SJ. Desmetramadol Has the Safety and Analgesic Profile of Tramadol Without Its Metabolic Liabilities: Consecutive Randomized, Double-Blind, Placebo- and Active Comparator-Controlled Trials. J Pain. 2019 Oct;20(10):1218-1235. doi: 10.1016/j.jpain.2019.04.005. Epub 2019 Apr 18.

  PMID: 31005596 DERIVED

MeSH Terms

Conditions

Pain; Agnosia

Interventions

Tramadol

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids

Study Officials

• Shawn Searle, MD

  PRA/CRI Lifetree Research Center

  PRINCIPAL INVESTIGATOR

• Stuart Kahn, MD

  Syntrix Biosystems, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2014
• First Posted: July 31, 2014
• Study Start: August 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: October 15, 2014

Record last verified: 2014-10

Locations

US (1)