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

NCT01133873 | Terminated Phase 4

• 1 other identifier: XP20C-101
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (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

  Day 13

Secondary Outcomes (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.

  Days -1, 1, 4, 11

Study Arms (2)

1

EXPERIMENTAL

Drug: Propoxyphene napsylate (XP20C)

2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Propoxyphene napsylate (XP20C) DRUG

100 mg capsules 6 times a day in ascending doses until a maximum tolerated dose is identified

Also known as: propoxyphene napsylate, Darvon-N, XP20C

1

Placebo DRUG

6 times a day in ascending doses until a maximum tolerated dose is identified

2

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xanodyne Pharmaceuticals: lead

Study Sites (1)

Lifetree Clinical Research

Salt Lake City, Utah, 84106, United States

Location

MeSH Terms

Interventions

propoxyphene napsylate; Levopropoxyphene

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Lynn R Webster, MD

  Lifetree Clinical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 24, 2010
• First Posted: May 31, 2010
• Study Start: June 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: April 13, 2011

Record last verified: 2011-04

Locations

US (1)