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

This study has been terminated.
Sponsor:
Information provided by:
Xanodyne Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01133873
First received: May 24, 2010
Last updated: April 12, 2011
Last verified: April 2011
  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:


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
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

No publications provided

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
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Analgesics, Opioid

ClinicalTrials.gov processed this record on July 22, 2014