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Multiple-Ascending-Dose Study to Evaluate the Safety of Propoxyphene Napsylate In Healthy Adult Subjects

Information source: Xanodyne Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Propoxyphene napsylate (XP20C) (Drug); Placebo (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: Xanodyne Pharmaceuticals

Official(s) and/or principal investigator(s):
Lynn R Webster, MD, Principal Investigator, Affiliation: Lifetree Clinical Research


The purpose of this study is to determine the daily maximum tolerated dose of propoxyphene napsylate in healthy subjects.

Clinical Details

Official title: A Randomized, Multiple-Dose, Double-Blind, Placebo-Controlled Study of Sequential Ascending Dose Levels to Assess the Safety, Tolerability and Electrocardiographic Effects of Propoxyphene Napsylate Capsules (and Its Metabolite Norpropoxyphene) When Administered Orally to Healthy Adult Subjects

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: 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

Secondary outcome: Establish the relationship between serum concentrations of propoxyphene and norpropoxyphene on cardiac conduction and pharmacokinetic linearity of sequentially increased dose levels of propoxyphene napsylate.


Minimum age: 18 Years. Maximum age: 49 Years. Gender(s): Both.


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


- 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

Locations and Contacts

Lifetree Clinical Research, Salt Lake City, Utah 84106, United States
Additional Information

Starting date: June 2010
Last updated: April 12, 2011

Page last updated: August 23, 2015

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