Healthy
Conditions
Brief summary
The purpose of this study is to determine the daily maximum tolerated dose of propoxyphene napsylate in healthy subjects.
Interventions
DRUGPropoxyphene napsylate (XP20C)
100 mg capsules 6 times a day in ascending doses until a maximum tolerated dose is identified
DRUGPlacebo
6 times a day in ascending doses until a maximum tolerated dose is identified
Sponsors
Xanodyne Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 49 Years
Healthy volunteers
Yes
Inclusion criteria
* Body mass index ≥ 18 and ≤ 30 (kg/m2) * Medically healthy with normal screening results, or in the case of results that are abnormal; the abnormal results are clinically insignificant (eg, medical history, physical examination, neurological assessment, vital signs, oxygen saturation, laboratory profiles) * 12-lead ECGs (calculations by the electrocardiograph) which have no clinically significant findings * Vital signs which are within normal range * No tobacco/nicotine-containing product use for a minimum of 6 months * If female, must be able to adhere to acceptable methods of contraception or be postmenopausal or surgically sterile
Exclusion criteria
* History or presence of significant cardiovascular, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, or neurological disease * History or presence of any degree of chronic obstructive pulmonary disease * History of suicidal ideations or depression requiring professional intervention including counseling or antidepressant medication * Any history of drug or alcohol abuse * Positive drug (urine)/alcohol (breath) testing at screening or check-in * Positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (HCV) * History of hypersensitivity or allergy to propoxyphene or any opioid compound, naloxone, naltrexone, palonosetron (Aloxi®), glycerin, senna, or bisacodyl (Dulcolax®) * Use of any prescription medication (with the exception of hormonal contraceptives for females) within 2 weeks of enrollment * Use of any over-the-counter medication, including herbal products, within 1 week of enrollment * Use of any drugs known to significantly inhibit or induce liver enzymes involved in drug metabolism \[CYP P450\]) within 30 days of enrollment * Blood donation or significant blood loss within 30 days of enrollment * Plasma donation within 7 days of enrollment * Participation in another clinical trial within 30 days of enrollment * Females who are pregnant or lactating * Any other condition or prior therapy, which, in the opinion of the PI, would make the subject unsuitable for this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determine the safety and tolerability of propoxyphene napsylate as determined by evaluation of adverse events, change from baseline of ventricular repolarization, lab results, and mental status | Day 13 |
Secondary
| Measure | Time frame |
|---|---|
| Establish the relationship between serum concentrations of propoxyphene and norpropoxyphene on cardiac conduction and pharmacokinetic linearity of sequentially increased dose levels of propoxyphene napsylate. | Days -1, 1, 4, 11 |
Countries
United States
Outcome results
None listed