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

Study Description

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Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Healthy	Drug: Propoxyphene napsylate (XP20C); Drug: Placebo	Phase 4

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	48 participants
Allocation:	Randomized
Intervention Model:	Single Group Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
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 Start Date :	June 2010
Actual Primary Completion Date :	November 2010
Actual Study Completion Date :	November 2010

Arms and Interventions

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Arm	Intervention/treatment
Experimental: 1	Drug: Propoxyphene napsylate (XP20C); 100 mg capsules 6 times a day in ascending doses until a maximum tolerated dose is identified; Other Names: propoxyphene napsylate; Darvon-N; XP20C
Placebo Comparator: 2	Drug: Placebo; 6 times a day in ascending doses until a maximum tolerated dose is identified

Outcome Measures

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Primary Outcome Measures :

1. 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 [ Time Frame: Day 13 ]

Secondary Outcome Measures :

1. Establish the relationship between serum concentrations of propoxyphene and norpropoxyphene on cardiac conduction and pharmacokinetic linearity of sequentially increased dose levels of propoxyphene napsylate. [ Time Frame: Days -1, 1, 4, 11 ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 49 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

Sponsors and Collaborators

Xanodyne Pharmaceuticals

Investigators

Principal Investigator:	Lynn R Webster, MD	Lifetree Clinical Research

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Gary Shangold, MD / Chief Medical Officer, Xanodyne Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT01133873 History of Changes
Other Study ID Numbers:	XP20C-101
First Posted:	May 31, 2010
Last Update Posted:	April 13, 2011
Last Verified:	April 2011

Additional relevant MeSH terms:

Dextropropoxyphene; Levopropoxyphene; Analgesics, Opioid; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs	Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Antitussive Agents; Respiratory System Agents