A Single-Dose, 1-Period, 1-Treatment Pilot Study of an Investigational Capsule Formulation of 2 mg/0.5 mg Buprenorphine/Naloxone Under Fasting Conditions

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Nanotherapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT00880841
First received: April 13, 2009
Last updated: May 5, 2009
Last verified: May 2009
  Purpose

A single-dose pilot study of an investigational capsule formulation of 2 mg/.05 mg Buprenorphine/Naloxone.

NIDA Contract No. HHSN271200577414C


Condition
Healthy

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: A Single-Dose, 1-Period, 1-Treatment Pilot Study of an Investigational Capsule Formulation of 2 mg/.05 mg Buprenorphine/Naloxone Under Fasting Conditions

Resource links provided by NLM:


Further study details as provided by Nanotherapeutics, Inc.:

Primary Outcome Measures:
  • to determine the pharmacokinetic profile of an investigational formulation of buprenorphine HCl/naloxone HCl 2mg/0.5mg oral capsules [ Time Frame: pk blood draws over a 72 hour period ] [ Designated as safety issue: Yes ]

Enrollment: 6
Study Start Date: April 2009
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
no treatment
phase 1a study for healthy normals

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

healthy normals between the ages of 18 and 55 (inclusive)

Criteria

Inclusion Criteria:

  • Subject must be a male or non-pregnant, non-breastfeeding female.
  • Subject must be between 18 and 55 years of age (inclusive).
  • Subject's Body Mass Index (BMI) must be between 18 and 30 kg/m2 (inclusive), and subject must weigh a minimum of 50 kg (110 lbs).
  • Female subjects - not surgically sterile for at least 6 months or at least 2 years postmenopausal - must agree to utilize one of the following forms of contraception, if sexually active with a male partner, from screening through completion of the study. Approved forms of contraception are abstinence, hormonal (oral, implant, transdermal, vaginal, or injection) in use at least 3 consecutive months prior to the first dose of study medication, double barrier (condom with spermicide; diaphragm with spermicide), intrauterine device (IUD), or vasectomized partner (6 months minimum since vasectomy).
  • Subject must voluntarily consent to participate in this study and provide their written informed consent prior to start of any study-specific procedures.
  • Subject is willing and able to remain in the study unit for the entire duration of the confinement period and return for any outpatient visits.

Exclusion Criteria:

  • History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, metabolic, dermatologic, neurologic, oncologic, or psychiatric disease or any other condition that, in the opinion of the Investigator, would jeopardize the safety of the subject or the validity of the study results.
  • Has a clinically significant abnormal finding on the physical exam, medical history, ECG, or clinical laboratory results at screening.
  • History or presence of allergic or adverse response to buprenorphine, naloxone, naltrexone, opioids, or any comparable or similar products.
  • Has been on a significantly abnormal diet during the 4 weeks preceding the first dose of study medication.
  • Has donated blood or plasma within 30 days prior to the first dose of study medication.
  • Has participated in another clinical trial within 30 days prior to the first dose of study medication.
  • Has used any over-the-counter (OTC) medication, including nutritional supplements, within 7 days prior to the first dose of study medication.
  • Has used any prescription medication, except hormonal contraceptive or hormonal replacement therapy, within 14 days prior to the first dose of study medication.
  • Has been treated with any known enzyme altering drugs, such as barbiturates, phenothiazines, cimetidine, carbamazepine, etc., within 30 days prior to the first dose of study medication.
  • Has smoked or used tobacco products within 60 days prior to the first dose of study medication.
  • Has history of substance abuse or dependence (including alcohol, opioids, or intravenous drug abuse)
  • Is a female with a positive pregnancy test result.
  • Has a positive urine screen for drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates).
  • Has a positive urine alcohol test at screening or a positive ethanol breath test at check-in for the study period or has consumed alcohol within 48 hours prior to screening or check-in for the study period.
  • Has had a positive test for, or has been treated for hepatitis B, hepatitis C, or HIV.
  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: NCT00880841

Locations
United States, Texas
CEDRA Clinical Research
Austin, Texas, United States, 78759
Sponsors and Collaborators
Nanotherapeutics, Inc.
Investigators
Principal Investigator: Mark Leibowitz, MD CEDRA Clinical Research
  More Information

No publications provided

Responsible Party: Angie Kimbler, CCRP, Clinical Trials Manager, Nanotherapeutics, Inc.
ClinicalTrials.gov Identifier: NCT00880841     History of Changes
Other Study ID Numbers: 20-A93-AU
Study First Received: April 13, 2009
Last Updated: May 5, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Nanotherapeutics, Inc.:
healthy normals, phase 1
phase 1a study for healthy normals

Additional relevant MeSH terms:
Buprenorphine
Naloxone
Analgesics, Opioid
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
Narcotic Antagonists

ClinicalTrials.gov processed this record on August 21, 2014