Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

Single-Dose PK Study of an Oxycodone/Acetaminophen Solution in Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02966860
Recruitment Status : Completed
First Posted : November 17, 2016
Last Update Posted : April 5, 2017
Sponsor:
Information provided by (Responsible Party):
Mallinckrodt

Brief Summary:
A single-dose study evaluating the oral PK of an oxycodone/apap solution in healthy subjects under fasted conditions

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: Oral solution OC/APAP Phase 1

Detailed Description:
An open-label, single-dose, single-center study evaluating the oral PK of an oxycodone/apap solutions in healthy subjects under fasted conditions

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Single-Dose Study Evaluating the Oral Pharmacokinetics of an Oxycodone/Acetaminophen Solution in Healthy Subjects Under Fasted Conditions
Study Start Date : August 2016
Actual Primary Completion Date : September 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Oxycodone and acetaminophen (OC/APAP)
Single 15 mL dose of oral solution of OC/APAP (total dose 15 mg oxycodone/975 mg acetaminophen)
Drug: Oral solution OC/APAP



Primary Outcome Measures :
  1. Area under the concentration-time curve from time 0 to the time of the last quantifiable sample (AUC0-t) [ Time Frame: 24 hours ]
  2. Observed maximum plasma concentration [ Time Frame: 24 hours ]
  3. Observed time to maximum plasma concentration [ Time Frame: 24 hours ]
  4. Apparent elimination half-life [ Time Frame: 24 hours ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects must be adequately informed and understands the nature and risks of the study and must be able to provide a signature and date on the informed consent form (ICF).
  • Subjects must have a health status of "healthy" assessed by the investigator, defined as no clinically significant deviation from normal in medical history, physical examination, and clinical laboratory determinations.
  • Subjects must be males or nonpregnant, nonlactating females, between 18 and 55 years of age (inclusive) at time of the Screening Visit.
  • Subjects must have a body mass index (BMI) ≥ 19.0 and ≤ 30.0 kg/m² with a minimum weight of 110 pounds for females and 130 pounds for males at the Screening Visit. The BMI will be calculated using the standard formula of weight (kg)/(height [m])2.
  • Female subjects must have a negative serum pregnancy test at the Screening Visit and check-in to the study site. All female subjects who are biologically capable of having children must agree and commit to the use of 2 acceptable methods of birth control, defined as nonhormonal forms of contraception, condoms or diaphragms with spermicidal foam 14 days prior to check-in to the study site and for the duration of study participation. Unacceptable methods of birth control include abstinence, hormone-containing intrauterine devices, uterine ablation, hormonal forms of contraception, rhythm, and withdrawal methods. Female subjects who are not biologically capable of having children are defined as postmenopausal female subjects who have been amenorrheic for at least 12 consecutive months prior to the Screening Visit or are surgically sterile.
  • Male subjects with reproductive potential must agree to use an acceptable method of contraception for the duration of the study (surgical sterilization [vasectomy] or condom with spermicide).
  • Subjects must be able to communicate effectively with study personnel.
  • Subjects must be able and willing to follow all protocol requirements and study restrictions.

Exclusion Criteria:

  • A subjects is ineligible for the study if he or she meets any of the following criteria at the Screening Visit or at check-in to the study site:
  • Subject is from a vulnerable population, as defined by the Code of Federal Regulations Title 45, Part 46, Section 46.111(b), including but not limited to employees (temporary, part-time, full time, etc.) or a family member of the research staff conducting the study, or of the sponsor, or of the clinical research organization, or of the institutional review board (IRB).
  • Subject has a history of any drug allergy, hypersensitivity, or intolerance to any opioids, APAP, or naltrexone which, in the opinion of the investigator, would place the subject at particular risk and compromise the safety of the subject in the study.
  • Subject has a positive test result for human immunodeficiency virus (HIV), hepatitis B (surface antigen), or hepatitis C virus antibody.
  • Subject has a thyroid-stimulating hormone (TSH) value that is outside the reference range at the Screening Visit.
  • Subject has donated or had significant loss of whole blood (480 mL or more) within 30 days, or plasma within 14 days, prior to the Screening Visit or plans to donate blood or plasma while enrolled in this study.
  • Subject has smoked or used nicotine-containing products 6 months prior to the Screening Visit.
  • Subject has current or recent (within 2 years of the Screening Visit) drug or alcohol abuse, as defined in Diagnostic and Statistical Manual of Mental Disorders Fifth Edition, Diagnostic Criteria for Drug and Alcohol Abuse.
  • Subject has current or recent (within 3 months of the Screening Visit) gastrointestinal (GI) disease (including, but not limited to, peptic ulcer, diverticulitis, bowel obstructions, adhesions, malabsorption, paralytic ileus, gastritis, or diarrhea) or any GI surgery that could impact the absorption of study drug (including, but not limited to, cholecystectomy and gastric bypass or gastric band surgery).
  • Subject had any major surgery within 3 months prior to the Screening Visit.
  • Subject has a history, or laboratory evidence of, a bleeding or clotting disorder or condition.
  • Subject is unable to tolerate venipuncture and/or venous access.
  • Subject has any medical, psychiatric and/or social reason for exclusion, as determined by the investigator.
  • Subject has a positive test result for drugs of abuse (minimum: opioids, barbiturates, cannabinoids, benzodiazepines, cocaine, amphetamine), cotinine, or alcohol at the Screening Visit or at check-in to the study site.
  • Subject used any other investigational medicinal product (study drug) within 30 days prior to the Screening Visit and throughout the duration of the study or plans to participate in another clinical study while concurrently enrolled in this study.
  • Subject has taken prescription drugs or over-the-counter (OTC) medications, vitamins, minerals, or dietary/herbal supplements (including grapefruit juice and grapefruit-containing products, St. John's wort and St. John's wort-containing products) within 14 days prior to check-in to the study site and throughout the duration of the study.
  • Subject has a history of conditions which might be specifically contraindicated or require caution to be used during the administration of any drug in the study.
  • Subject presents with a history of acute illness within 14 days prior to check-in to the study site and throughout the duration of the study.
  • Subject has an electrocardiogram (ECG) parameter (confirmed by repeat evaluation) outside the following limits: PR ≥ 210 ms, QRS ≥ 120 ms, QT ≥ 500 ms; QT interval corrected for heart rate incorporating Bazett's formula (QTcB) ≥ 450 ms.
  • Subject has other clinically significant ECG abnormalities, as assessed by the investigator.
  • Subject has an oxygen saturation of < 95%.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02966860


Locations
Layout table for location information
United States, Texas
PPD Phase 1 Clinic
Austin, Texas, United States, 78744
Sponsors and Collaborators
Mallinckrodt

Layout table for additonal information
Responsible Party: Mallinckrodt
ClinicalTrials.gov Identifier: NCT02966860    
Other Study ID Numbers: MNK15141038
First Posted: November 17, 2016    Key Record Dates
Last Update Posted: April 5, 2017
Last Verified: April 2017
Additional relevant MeSH terms:
Layout table for MeSH terms
Acetaminophen
Acetaminophen, hydrocodone drug combination
Oxycodone
Pharmaceutical Solutions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents