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

Purpose

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

Condition	Intervention	Phase
Healthy	Drug: Propoxyphene napsylate (XP20C) Drug: Placebo	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, 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

Resource links provided by NLM:

Drug Information available for: Propoxyphene hydrochloride Propoxyphene napsylate

U.S. FDA Resources

Further study details as provided by Xanodyne Pharmaceuticals:

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]


Estimated Enrollment:	48
Study Start Date:	June 2010
Study Completion Date:	November 2010
Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


Ages Eligible for Study:	18 Years to 49 Years (Adult)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01133873

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


Responsible Party:	Gary Shangold, MD / Chief Medical Officer, Xanodyne Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT01133873 History of Changes
Other Study ID Numbers:	XP20C-101
Study First Received:	May 24, 2010
Last Updated:	April 12, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:


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

ClinicalTrials.gov processed this record on September 29, 2016