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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

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.

Condition or disease Intervention/treatment Phase
Moderate to Severe Chronic Pain Drug: NKTR-181 Drug: Oxycodone IR Phase 1

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
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
Official Title: 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
Actual Study Start Date : October 22, 2018
Actual Primary Completion Date : December 17, 2019
Actual Study Completion Date : January 3, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: MRI Scans

Arm Intervention/treatment
Experimental: Group 1
NKTR-181 400 mg and oxycodone IR placebo
Drug: NKTR-181
A combination of NKTR-181 and oxycodone IR placebo

Experimental: Group 2
Oxycodone IR 40 mg and NKTR-181 placebo
Drug: Oxycodone IR
A combination of oxycodone IR and NKTR-181 placebo




Primary Outcome Measures :
  1. Functional MRI BOLD signal in brain following NKTR-181 administration [ Time Frame: 8 hour period following dose administration Day 1 to 2 ]

Secondary Outcome Measures :
  1. Change in pupil diameter via pupillometry [ Time Frame: Day 1 to 19 ]
  2. PK parameters [ex: maximum plasma drug concentration (Cmax)] [ Time Frame: 24 hour period following dose administration Day 1 to 2 ]
  3. PK parameters [ex: time to maximum concentration (Tmax)] [ Time Frame: 24 hour period following dose administration Day 1 to 2 ]
  4. Number of subjects with Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Day 1 to 19 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

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): NCT03802227


Locations
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United States, Virginia
Investigator Site - Richmond
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Nektar Therapeutics
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Responsible Party: Nektar Therapeutics
ClinicalTrials.gov Identifier: NCT03802227    
Other Study ID Numbers: 18-181-26
First Posted: January 14, 2019    Key Record Dates
Last Update Posted: February 18, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations
Oxycodone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents