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Clinical Trials/NCT02735629
NCT02735629UnknownPhase 2

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

RespireRx1 site in 1 country18 target enrollmentStarted: March 2016Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Sponsor
Enrollment
18
Locations
1
Primary Endpoint
Respiratory depression
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Prevention
Masking
Triple (Participant, Care Provider, Investigator)

Eligibility Criteria

Ages
18 Years to 50 Years (Adult)
Sex
Male
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •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

Exclusion Criteria

  • •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
  • •Blood or plasma donation of more than 500 mL during the month before randomization and more than 50 mL in the 2 weeks before randomization

Arms & Interventions

CX1739 - 300 mg

Experimental

Study Drug - low dose

Intervention: CX1739 - 300 mg (Drug)

Placebo

Placebo Comparator

Placebo

Intervention: Placebo (Drug)

CX1739 - 600 mg

Experimental

Study drug - mid Dose

Intervention: CX1739 - 600 mg (Drug)

CX1739 - 900 mg

Experimental

Study drug - high dose

Intervention: CX1739 - 900 mg (Drug)

Outcomes

Primary Outcomes

Respiratory depression

Time Frame: Sequence #1 - 30 minutes

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

Secondary Outcomes

  • 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)
  • Maintenance of sedation(Sequence #1 - 30 minutes)
  • Pain tolerance threshold(Sequence #2 - 20 minutes)

Investigators

Sponsor
RespireRx
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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