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

April 13, 2009
May 5, 2009
April 2009
May 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00880841 on ClinicalTrials.gov Archive Site
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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
A Single-Dose, 1-Period, 1-Treatment Pilot Study of an Investigational Capsule Formulation of 2 mg/.05 mg Buprenorphine/Naloxone Under Fasting Conditions

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

NIDA Contract No. HHSN271200577414C

Not Provided
Observational
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

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

Healthy
Not Provided
no treatment
phase 1a study for healthy normals
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
6
May 2009
May 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00880841
20-A93-AU
No
Angie Kimbler, CCRP, Clinical Trials Manager, Nanotherapeutics, Inc.
Nanotherapeutics, Inc.
National Institute on Drug Abuse (NIDA)
Principal Investigator: Mark Leibowitz, MD CEDRA Clinical Research
Nanotherapeutics, Inc.
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP