Phase 1
Completed N=24
A Randomized Study Investigating Oral Desmetramadol Dose Proportionality and Food Effect In Normal Human Subjects
Source: ClinicalTrials.gov NCT04683926 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Apr 2023
Primary outcomePrimary: (-/+)-M1, AUC(0-32) and AUC(Inf) — 136.0; 274.9; 408.8; 450.7 ng*hr/mL
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY (-/+)-M1, AUC(0-32) and AUC(Inf) |
136.0; 274.9; 408.8; 450.7; 138.0; 279.0 | — |
| PRIMARY (-/+)-M1, Cmax |
12.41; 24.22; 36.27; 43.42 | — |
| SECONDARY Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment. |
3; 4; 5; 6 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy males and females with vital signs as follows at screening: systolic blood pressure > 90 mm Hg and 40 mm Hg and 50 Kg and a body mass index (BMI) of 18.0 to 32.0 kg/m (inclusive).
- Non-smoker of tobacco for a minimum of the past 3 months, and negative urine continine test.
Exclusion Criteria
- Oral temperature > 38°C or 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.
- Having undergone gall bladder removal.
- 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.
- History of previous anaphylaxis, severe allergic reaction to tramadol, codeine, or other opioid drugs.
- 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.
- Females must not be 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 within five half-lives of Day -1, 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.
Data sourced from ClinicalTrials.gov (NCT04683926). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.