Antagonism of Opioid-Induced Respiratory Depression by CX1739 With Preservation of Opioid Analgesia

NCT02735629 | Unknown Phase 2

• 1 other identifier: CRTX-05
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The study is an investigation to assess the capacity of ascending doses of CX1739 to antagonize the respiratory depressive effect of remifentanil. The study will also investigate whether ascending doses of CX1739 reduce the analgesic effect of remifentanil or alter the BIS measure of sedation and will evaluate the safety of CX1739 when used in conjunction with remifentanil.

Conditions

Opiate Induced Respiratory Depression

Outcome Measures

Primary Outcomes (1)

• Respiratory depression

  Respiratory rate, tidal volume, minute volume as determined by plethysmography

  Sequence #1 - 30 minutes

Secondary Outcomes (4)

• Pain tolerance threshold

  Sequence #2 - 20 minutes

• Maintenance of sedation

  Sequence #1 - 30 minutes

• The number of patients that experience an adverse drug reaction upon ingestion of CX1739 when used alone or in conjunction with remifentanil

  up to 5 weeks

• Change in pupil size

  Sequence #2 - 20 minutes

Study Arms (4)

CX1739 - 300 mg

EXPERIMENTAL

Study Drug - low dose

Drug: CX1739 - 300 mg

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

CX1739 - 600 mg

EXPERIMENTAL

Study drug - mid Dose

Drug: CX1739 - 600 mg

CX1739 - 900 mg

EXPERIMENTAL

Study drug - high dose

Drug: CX1739 - 900 mg

Interventions

CX1739 - 300 mg DRUG

Ampakine CX1739 - 300 mg

Also known as: Low dose

CX1739 - 300 mg

CX1739 - 600 mg DRUG

CX1739 - 600 mg

Also known as: mid dose

CX1739 - 600 mg

CX1739 - 900 mg DRUG

CX1739 - 900 mg

Also known as: high dose

CX1739 - 900 mg

Placebo DRUG

Placebo to 300 mg CX1739

Also known as: Placebo to 300 mg CX1739

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• To be eligible for this trial, subjects must meet all of the following criteria:
• Males 18 to 50 years of age, inclusive
• Body mass index of 18.0 to 30.0 kg/m2, inclusive, using the formula: weight (kg)/height (m)2
• Healthy, as determined by medical history, physical examination including vital signs, and clinical laboratory test results
• American Society of Anesthesiologists Physical Status Classification 1
• Willing and able to provide voluntary, written informed consent

You may not qualify if:

• If a subject meets any of the following criteria, he cannot be enrolled in the study:
• History of any chronic illness or evidence of clinically significant organic or psychiatric disease on medical history or physical examination which, in the opinion of the principal investigator (PI), would confound the study results or present a risk to the subject
• Acute illness within 2 weeks before dosing
• History of any clinically significant pulmonary condition (eg, asthma) within the last 2 years requiring admission to the hospital
• Previous diagnosis of obstructive sleep apnea based on polysomnography
• Currently using any prescription medication or use within the last 30 days
• Laboratory values (clinical chemistry, hematology, urinalysis) outside the laboratory reference range considered clinically significant (NOTE: in the event of any parameter lying outside of the normal range, the sample may be repeated once; this value will be accepted if it lies within the normal range)
• Presence of QT interval corrected \> 440 msec on ECG
• Resting HR while awake \< 45 or \> 90 beats/minute
• History of daily use of tobacco or other nicotine-containing products within 1 year of study entry or positive cotinine test at screening and subsequent study visits
• History of allergic hypersensitivity to ampakines (CX717, CX1739), remifentanil, naloxone, or any component of these formulations; history of multiple drug allergies
• History or current evidence of abuse of any drug substance, licit or illicit, including alcohol; positive urine drug screen (UDS) for drugs of abuse at screening
• Inability to understand the protocol requirements; instructions; study-related restrictions; or nature, scope, and possible consequences of the study
• Unlikely to complete the study, eg, because of inability to return for follow-up visits
• Participation in another study with any investigational drug in the 3 months preceding this study

Sponsors & Collaborators

• RespireRx: lead
• Duke University: collaborator

Study Sites (1)

Duke Clinical Research Unit

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Interventions

Contraceptives, Oral

Intervention Hierarchy (Ancestors)

Contraceptive Agents, Female; Contraceptive Agents; Reproductive Control Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses

Study Officials

• Richard Purcell

  RespireRx Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2016
• First Posted: April 13, 2016
• Study Start: March 1, 2016
• Primary Completion: August 1, 2016
• Study Completion: September 1, 2016
• Last Updated: July 28, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)