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

NCT ID: NCT01133873

Last Updated: 2011-04-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2010-11-30

Brief Summary

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

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

Group Type: EXPERIMENTAL

Propoxyphene napsylate (XP20C)

Intervention Type: DRUG

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

2

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

Propoxyphene napsylate (XP20C)

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

propoxyphene napsylate; Darvon-N; XP20C

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Xanodyne Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Xanodyne Pharmaceuticals, Inc.

Principal Investigators

Lynn R Webster, MD

Role: PRINCIPAL_INVESTIGATOR

Lifetree Clinical Research

Locations

Lifetree Clinical Research

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

XP20C-101

Identifier Type: -

Identifier Source: org_study_id