A Study in Opioid-Experienced, Non-Dependent Recreational Drug Users to Determine the Abuse Potential and Safety of CL-108 Tablets Administered Via the Oral Route

NCT02712554 | Completed Phase 1 Results

• 1 other identifier: CLCT-007
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to assess the abuse potential of CL-108 tablets, including the abuse deterrent effects of promethazine, following oral administration, relative to hydrocodone/acetaminophen (APAP) tablets and placebo in non-dependent, recreational opioid users.

Conditions

Pain; Nausea; Vomiting

Keywords

Pain; Nausea; Vomiting

Outcome Measures

Primary Outcomes (3)

• Subjective Effects: Maximum Effect (Emax) and Minimum Effect (Emin) of High Visual Analog Scale (VAS) in Dose Selection Phase

  High VAS measures the positive effects experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (0 mm = 'definitely not') to 'extremely' (100 mm = 'definitely so'). For VAS assessment, pre-dose (baseline) value was subtracted from each post-dose value prior to calculation of the pharmacodynamic (PD) parameter. Emax is the largest effect score and Emin is the smallest effect score between 0 to 24 hours post-dose.

  0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours (post-dose)

• Subjective Effects: Emax of Any Effects VAS in Dose Selection Phase

  Any drug effects VAS measures other subjective effects experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (0 mm = 'definitely not') to 'extremely' (100 mm = 'definitely so'). Emax is the largest effect score between 0 (pre-dose) to 24 hours post-dose.

  0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours (post-dose)

• Emax of Drug Liking VAS in Treatment Phase

  Drug liking VAS is the measure of balance of effects that assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 millimeter (mm) bipolar (VAS) anchored in the center with a neutral anchor of 'neither like nor dislike' (score of 50 mm), on the left with 'strong disliking' (score of 0 mm) and on the right with 'strong liking' (score of 100 mm). Emax is the largest effect score between 0.5 to 24 hours post-dose.

  0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 24 hours

Secondary Outcomes (19)

• Number of Adverse Events in Dose Selection Phase

  Up to visit 3 (Follow up)

• Balance of Effects: Emin of Drug Liking VAS in Treatment Phase

  0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours

• Balance of Effects: Time-averaged Area Under the Effect Curve (TA_AUE) of Drug Liking VAS in Treatment Phase

  0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours

• Balance of Effects: Emax and Emin of Overall Drug Liking VAS in Treatment Phase

  0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours

• Balance of Effects: Emax and Emin of Take Drug Again VAS in Treatment Phase

  0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours

Study Arms (5)

Treatment A:CL-108 22.5mg/975mg/37.5mg

EXPERIMENTAL

CL-108 22.5 mg/975 mg/37.5 mg tablet by mouth

Drug: CL-108

Treatment B:CL-108 37.5mg/1625mg/62.5mg

EXPERIMENTAL

CL-108 37.5 mg/1625 mg/62.5 mg tablet by mouth

Drug: CL-108

Treatment C:M366 22.5mg/975mg

ACTIVE COMPARATOR

M366 22.5 mg/975 mg tablet by mouth

Drug: M366

Treatment D: M366 37.5mg/1625mg

ACTIVE COMPARATOR

M366 37.5 mg/1625 mg tablet by mouth

Drug: M366

Treatment E: Placebo

PLACEBO COMPARATOR

Placebo 0 mg tablet by mouth

Drug: Placebo

Interventions

CL-108 DRUG

7.5 mg/325 mg/12.5 mg tablet

Also known as: Low-dose CL-108 and High-dose CL-108

Treatment A:CL-108 22.5mg/975mg/37.5mg; Treatment B:CL-108 37.5mg/1625mg/62.5mg

M366 DRUG

7.5 mg/325 mg tablet

Also known as: Low-dose M366 and High-dose M366

Treatment C:M366 22.5mg/975mg; Treatment D: M366 37.5mg/1625mg

Placebo DRUG

Also known as: 0 mg tablet

Treatment E: Placebo

Eligibility Criteria

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

You may qualify if:

• BMI within 18.0 to 33.0 kg/m2, inclusive (minimum weight of 50.0 kg at Screening)
• Healthy, as determined by no clinically significant medical history, physical examination findings, 12-lead ECG findings, vital signs measurements, and laboratory results at screening, as judged by the investigator
• Current opioid users who had used oral opioids for recreational (non-therapeutic) purposes, at least 10 times in the past year

You may not qualify if:

• Drug or alcohol dependence within the last 12 months (except nicotine)
• Subjects who had ever been in treatment for substance use disorders (except smoking cessation
• History of presence of any clinically significant cardiac, neurologic, pulmonary, psychiatric, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, dermatologic, renal, or other major disease at screening, which in the opinion of the investigator, would have jeopardized the safety of the subject or the validity of the study results
• History or presence of hypotension, judged to be clinically significant based on investigator judgement

Sponsors & Collaborators

• Charleston Laboratories, Inc: lead

MeSH Terms

Conditions

Pain; Nausea; Vomiting

Interventions

Tablets

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: Chief Commercial Officer
• Organization: Charleston Laboratories, Inc.

cliregulatory@charlestonlabs.com

561-748-2007

Study Officials

• Bernard P Schachtel, M.D

  Charleston Laboratories

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2016
• First Posted: March 18, 2016
• Study Start: June 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: October 14, 2019
• Results First Posted: October 14, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share