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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01133873
• Other study ID #: XP20C-101
• Status: Terminated
• Phase: Phase 4
• First received: May 24, 2010
• Last updated: April 12, 2011
• Start date: June 2010
• Est. completion date: November 2010

Study information

• Verified date: April 2011
• Source: Xanodyne Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 48
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 49 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Propoxyphene napsylate (XP20C)
100 mg capsules 6 times a day in ascending doses until a maximum tolerated dose is identified
• Placebo
6 times a day in ascending doses until a maximum tolerated dose is identified

Locations

Country	Name	City	State
United States	Lifetree Clinical Research	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Xanodyne Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes