Overview

This trial is active, not recruiting.

Condition opiate induced respiratory depression
Treatments cx1739 - 300 mg, cx1739 - 600 mg, cx1739 - 900 mg, placebo
Phase phase 2
Sponsor RespireRx
Collaborator Duke University
Start date March 2016
End date August 2016
Trial size 18 participants
Trial identifier NCT02735629, CRTX-05

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model crossover assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose prevention
Arm
(Experimental)
Study Drug - low dose
cx1739 - 300 mg Low dose
Ampakine CX1739 - 300 mg
(Placebo Comparator)
Placebo
placebo Placebo to 300 mg CX1739
Placebo to 300 mg CX1739
(Experimental)
Study drug - mid Dose
cx1739 - 600 mg mid dose
CX1739 - 600 mg
(Experimental)
Study drug - high dose
cx1739 - 900 mg high dose
CX1739 - 900 mg

Primary Outcomes

Measure
Respiratory depression
time frame: Sequence #1 - 30 minutes

Secondary Outcomes

Measure
Pain tolerance threshold
time frame: Sequence #2 - 20 minutes
Maintenance of sedation
time frame: 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
time frame: up to 5 weeks
Change in pupil size
time frame: Sequence #2 - 20 minutes

Eligibility Criteria

Male participants from 18 years up to 50 years old.

Inclusion Criteria: - To be eligible for this trial, subjects must meet all of the following criteria: 1. Males 18 to 50 years of age, inclusive 2. Body mass index of 18.0 to 30.0 kg/m2, inclusive, using the formula: weight (kg)/height (m)2 3. Healthy, as determined by medical history, physical examination including vital signs, and clinical laboratory test results 4. American Society of Anesthesiologists Physical Status Classification 1 5. 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: 1. 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 2. Acute illness within 2 weeks before dosing 3. History of any clinically significant pulmonary condition (eg, asthma) within the last 2 years requiring admission to the hospital 4. Previous diagnosis of obstructive sleep apnea based on polysomnography 5. Currently using any prescription medication or use within the last 30 days 6. 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) 7. Presence of QT interval corrected > 440 msec on ECG 8. Resting HR while awake < 45 or > 90 beats/minute 9. 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 10. History of allergic hypersensitivity to ampakines (CX717, CX1739), remifentanil, naloxone, or any component of these formulations; history of multiple drug allergies 11. 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 12. Inability to understand the protocol requirements; instructions; study-related restrictions; or nature, scope, and possible consequences of the study 13. Unlikely to complete the study, eg, because of inability to return for follow-up visits 14. Participation in another study with any investigational drug in the 3 months preceding this study 15. 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

Additional Information

Official title Antagonism of Opioid-Induced Respiratory Depression by CX1739 With Preservation of Opioid Analgesia
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by RespireRx.