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A Study Using Functional Magnetic Resonance Imaging to Evaluate the Effect of NKTR-181 on Brain Activity in Healthy, Non-physically Dependent Recreational Opioid Users.

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: NCT03802227
Recruitment Status : Terminated (Sponsor Decision)
First Posted : January 14, 2019
Last Update Posted : February 18, 2020
Sponsor:
Information provided by (Responsible Party):
Nektar Therapeutics

Tracking Information
First Submitted Date  ICMJE November 15, 2018
First Posted Date  ICMJE January 14, 2019
Last Update Posted Date February 18, 2020
Actual Study Start Date  ICMJE October 22, 2018
Actual Primary Completion Date December 17, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 10, 2019)
Functional MRI BOLD signal in brain following NKTR-181 administration [ Time Frame: 8 hour period following dose administration Day 1 to 2 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 10, 2019)
  • Change in pupil diameter via pupillometry [ Time Frame: Day 1 to 19 ]
  • PK parameters [ex: maximum plasma drug concentration (Cmax)] [ Time Frame: 24 hour period following dose administration Day 1 to 2 ]
  • PK parameters [ex: time to maximum concentration (Tmax)] [ Time Frame: 24 hour period following dose administration Day 1 to 2 ]
  • Number of subjects with Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Day 1 to 19 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study Using Functional Magnetic Resonance Imaging to Evaluate the Effect of NKTR-181 on Brain Activity in Healthy, Non-physically Dependent Recreational Opioid Users.
Official Title  ICMJE A Phase 1 Double-Blind, Double-Dummy, Parallel-Group, Randomized, Positive Control Study Using Functional Magnetic Resonance Imaging to Evaluate the Effect of NKTR-181 on Brain Activity in Healthy, Non-physically Dependent Recreational Opioid Users
Brief Summary The main purpose of this study is to evaluate the effect of NKTR-181 on brain activity in healthy, non-physically dependent recreational opioid users. This study will last about 88 days for each participant.
Detailed Description This study is a single-center study in which approximately 24 subjects will be randomized to one of two treatment groups. Subjects will enter a screening period between Day -28 and Day -2. Upon meeting all criteria for enrollment, on Day -1 subjects will enter the clinical research study unit (CRSU) for an overnight confinement. On Day 1, subjects will undergo a baseline MRI and will then be randomized to NKTR-181 or oxycodone immediate release (IR). Once randomized, subjects will receive a single dose of study drug (NKTR-181 or oxycodone IR) and matched alternate-treatment placebo. Subjects will undergo a series of three fMRIs (functional magnetic resonance imaging) post dose (at hours 1, 2, and 4). At post-dose hours 0.5, 1, 2, 3, 4, 5, 6, and 8, pupillometry will be performed and PK blood samples will be drawn. Following a 14- to 17-day safety follow-up period, subjects will return to the research facility clinic for the End of Study (EOS) visit (Day 16-19).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
A double-blind, double-dummy, parallel-group, randomized, positive control study.
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Moderate to Severe Chronic Pain
Intervention  ICMJE
  • Drug: NKTR-181
    A combination of NKTR-181 and oxycodone IR placebo
  • Drug: Oxycodone IR
    A combination of oxycodone IR and NKTR-181 placebo
Study Arms  ICMJE
  • Experimental: Group 1
    NKTR-181 400 mg and oxycodone IR placebo
    Intervention: Drug: NKTR-181
  • Experimental: Group 2
    Oxycodone IR 40 mg and NKTR-181 placebo
    Intervention: Drug: Oxycodone IR
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 14, 2020)
8
Original Estimated Enrollment  ICMJE
 (submitted: January 10, 2019)
24
Actual Study Completion Date  ICMJE January 3, 2020
Actual Primary Completion Date December 17, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  • Healthy male and female recreational opioid users, 18-65 years of age inclusive.
  • Body Mass Index (BMI) between 19.0 to 45.0kg/m2
  • Have at least one urine drug screen positive for opioids during Screening to confirm recreational opioid use. Subjects testing positive for methadone or buprenorphine prescribed for treatment will be excluded.
  • Subjects must agree to practice adequate contraception as outlined in the protocol.

Key Exclusion Criteria:

  • Any metal fragments or other bodily metal that would pose a risk to subjects during MRI scanning as determined by the MRI technologist and/or MRI physicist
  • Any clinically significant disease or condition that might compromise the cardiovascular, hematological, renal, hepatic, pulmonary, endocrine, central nervous, or gastrointestinal systems or other conditions that may interfere with the absorption, distribution, metabolism, or excretion of the study drug or would place the subject at increased risk
  • History of clinically significant acute asthma or other obstructive airway disease requiring daily controller medication or any condition that may increase the risk for respiratory depression
  • Current neurologic conditions such as convulsive disorders, or history of severe head injury.
  • Any current DSM-5 axis I psychiatric disorder or neurological disorder requiring ongoing treatment
  • Current substance use disorder (moderate to severe), other than Opioid, Nicotine, THC (tetrahydrocannabinol), cocaine, or caffeine as defined by DSM-5
  • Physical dependence of opioids
  • History of claustrophobia or any other psychiatric disorder that would preclude subject tolerance of MRI procedures.
  • Current use of any medication that could affect central nervous system blood flow (e.g. certain cardiovascular medications, triptan migraine medications)
  • Clinical Opiate Withdrawal Scale (COWS) score of greater than 5 during screening or prior to first scan.
  • Positive urine drug screen for buprenorphine or methadone immediately prior to the first scan.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03802227
Other Study ID Numbers  ICMJE 18-181-26
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nektar Therapeutics
Study Sponsor  ICMJE Nektar Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Nektar Therapeutics
Verification Date February 2020

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