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

NCT ID: NCT02735629

Last Updated: 2016-07-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2016-09-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

CX1739 - 300 mg

Study Drug - low dose

Group Type: EXPERIMENTAL

CX1739 - 300 mg

Intervention Type: DRUG

Ampakine CX1739 - 300 mg

Placebo

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo to 300 mg CX1739

CX1739 - 600 mg

Study drug - mid Dose

Group Type: EXPERIMENTAL

CX1739 - 600 mg

Intervention Type: DRUG

CX1739 - 600 mg

CX1739 - 900 mg

Study drug - high dose

Group Type: EXPERIMENTAL

CX1739 - 900 mg

Intervention Type: DRUG

CX1739 - 900 mg

Interventions

CX1739 - 300 mg

Ampakine CX1739 - 300 mg

Intervention Type: DRUG

CX1739 - 600 mg

CX1739 - 600 mg

Intervention Type: DRUG

CX1739 - 900 mg

CX1739 - 900 mg

Intervention Type: DRUG

Placebo

Placebo to 300 mg CX1739

Intervention Type: DRUG

Other Intervention Names

Low dose; mid dose; high dose; Placebo to 300 mg CX1739

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Duke University

OTHER

Sponsor Role: collaborator

RespireRx

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard Purcell

Role: STUDY_DIRECTOR

RespireRx Pharmaceuticals

Locations

Duke Clinical Research Unit

Durham, North Carolina, United States

Countries

United States

Other Identifiers

CRTX-05

Identifier Type: -

Identifier Source: org_study_id