Assessment of Abuse Potential of Cebranopadol in Humans

NCT05256108 | Completed Phase 1 FDA Drug

• 1 other identifier: PARK-101-HAP
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

This study will be conducted to evaluate the abuse potential of single doses of cebranopadol as compared with oxycodone, tramadol and matching placebo in recreational drug users.

Conditions

Human Abuse Potential

Keywords

pain; abuse; opioid

Outcome Measures

Primary Outcomes (1)

• Drug Liking Visual analog scale (VAS) Emax

  The scale is a 0-100-point scale: 0 = "Strong disliking"; 50 = "Neither like nor dislike"; 100 = "Strong liking"

  Treatment Phase: Intervals from predose to 48 hours post-dose

Secondary Outcomes (4)

• VAS rating for Overall Liking

  Treatment Phase: Intervals from predose to 48 hours post-dose

• VAS rating for Take Drug Again

  Treatment Phase: Intervals from predose to 48 hours post-dose

• Pupillometry

  Treatment Phase: Intervals from predose to 48 hours post-dose

• Multi-Tasking Test

  Treatment Phase: Intervals from predose to 48 hours post-dose

Study Arms (5)

Cebranopadol 600 µg

EXPERIMENTAL

Single oral dose of 6 capsules containing 3 cebranopadol 200 µg tablets and placebo

Drug: Cebranopadol 600 µg

Cebranopadol 1000 µg

EXPERIMENTAL

Single oral dose of 6 capsules containing 5 cebranopadol 200 µg tablets and placebo

Drug: Cebranopadol 1000 µg

Oxycodone 40 mg

ACTIVE COMPARATOR

Single oral dose of 6 capsules containing 2 oxycodone 20 mg and placebo

Drug: Oxycodone 40 mg

Tramadol 600 mg

ACTIVE COMPARATOR

Single oral dose of 6 capsules containing 6 tramadol 100 mg tablets

Drug: Tramadol 600 mg

Placebo

PLACEBO COMPARATOR

Single oral dose of 6 capsules containing placebo

Drug: Placebo

Interventions

Oxycodone 40 mg DRUG

Participants will be administered a single dose of 6 capsules containing oxycodone and placebo in a randomized crossover manner

Also known as: Qualification Phase/ Treatment Phase

Oxycodone 40 mg

Tramadol 600 mg DRUG

Participants will be administered a single dose of 6 capsules containing tramadol in a randomized crossover manner

Also known as: Qualification Phase/ Treatment Phase

Tramadol 600 mg

Placebo DRUG

Participants will be administered a single dose of 6 capsules containing placebo in a randomized crossover manner

Also known as: Qualification Phase/ Treatment Phase

Placebo

Cebranopadol 600 µg DRUG

Participants will be administered a single dose of 6 capsules containing cebranopadol and placebo in a randomized crossover manner

Also known as: Treatment Phase

Cebranopadol 600 µg

Cebranopadol 1000 µg DRUG

Participants will be administered a single dose of 6 capsules containing cebranopadol and placebo in a randomized crossover manner

Also known as: Treatment Phase

Cebranopadol 1000 µg

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Willing and able to provide written informed consent
• Adult men or women aged 18 to 55 years, inclusive
• History of recreational opioid use defined as non therapeutic use at least 10 times in the subject's lifetime and at least once in the 12 weeks prior to the Enrollment Visit
• Body mass index between 19 kg/m2 and 32 kg/m2 inclusive, with a body weight of not less than 50 kg at Enrollment
• Subjects must be in good health as determined by medical history, physical examination, 12 lead electrocardiogram (ECG), and vital signs (pulse rate, systolic blood pressure and diastolic blood pressure, respiratory rate, and oxygen saturation using pulse oximetry) at Enrollment

You may not qualify if:

• Self-reported history of drug or alcohol dependence (lifetime) other than caffeine or nicotine as defined by DSM IV-TR criteria
• Current treatment or treatment within their lifetime for substance disorders, other than treatment for smoking cessation
• Positive or missing alcohol breath test at Enrollment; the alcohol breath test can be repeated and/or the subject rescheduled at the discretion of the investigator or designee
• Pregnant or breastfeeding or missing pregnancy test
• Unwillingness or inability to abstain from recreational drug use for the duration of the trial
• Current consumption of greater than 20 cigarettes per day or inability to abstain from smoking (or use of any nicotine-containing substance) for at least 8 hours
• Participation in another clinical trial within 30 days prior to Enrollment that resulted in the administration of at least 1 dose of IMP
• Diseases or conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs. Subjects with a history of cholecystectomy are not excluded
• Prolongation of QTcF (after repeated assessment) at Enrollment, i.e., \>450 ms for men or \>470 ms for women, or presence of additional risk factors for torsade de pointes (e.g., heart failure, hypokalemia), or use of concomitant medications that prolong the QT interval
• History of orthostatic hypotension or other cardiovascular diseases
• Any clinically significant disease that in the investigator's opinion may affect efficacy or safety assessments or may compromise the subject's safety during trial participation, e.g., significant pulmonary, gastrointestinal, cardiac, endocrine, metabolic, neurological, or psychiatric disorders
• Definite or suspected history of drug allergy or hypersensitivity to opioids or opioid antagonists
• Use of prescription medications within the longer of 14 days or 5 half-lives or use of over-the-counter medications within the longer of 7 days or 5 half-lives prior to dosing, exceptions may be made on a case-by-case basis (e.g., for medications with a short half-life or for topical medications) if approved by the medical monitor in agreement with the investigator
• Any contraindication for naloxone, oxycodone IR, or tramadol IR administration
• Not able to abstain from consumption of beverages or food containing caffeine (tea, coffee, cola, chocolate, etc.) or alcohol from 2 days prior to each Day 1 until discharge from the research unit; beverages or food containing quinine (e.g., bitter lemon, tonic water) from 1 week before Day 1 of the Qualification Phase until the final examination; grapefruit juice (sweet or sour) or Seville oranges from 1 week before Day 1 of the Qualification Phase until the final examination.

Sponsors & Collaborators

• Tris Pharma, Inc.: lead

Study Sites (1)

Ohio Clinical Trials

Columbus, Ohio, 43212, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Oxycodone; Tramadol; 6'-fluoro-4',9'-dihydro-N,N-dimethyl-4-phenylspiro(cyclohexane-1,1'(3'H)-pyrano(3,4-b)indol)-4-amine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: To ensure blinding to the treatment, subjects will receive 6 identically looking capsules that will contain one of the 5 assigned treatments. Subjects will be randomized 1:1:1:1:1 and will receive one of 2 cebranopadol doses: oxycodone IR: tramadol IR: placebo in each of the 5 treatment periods.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, single site, double-blind, placebo- and active-controlled, crossover, single oral dose, Phase 1 trial, in non dependent recreational opioid users

Study Record Dates

• First Submitted: February 16, 2022
• First Posted: February 25, 2022
• Study Start: March 28, 2022
• Primary Completion: July 12, 2022
• Study Completion: July 12, 2022
• Last Updated: July 27, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)