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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02735629
Other study ID # CRTX-05
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received March 23, 2016
Last updated July 27, 2016
Start date March 2016
Est. completion date September 2016

Study information

Verified date July 2016
Source RespireRx
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 18
Est. completion date September 2016
Est. primary completion date August 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 50 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
CX1739 - 300 mg
Ampakine CX1739 - 300 mg
CX1739 - 600 mg
CX1739 - 600 mg
CX1739 - 900 mg
CX1739 - 900 mg
Placebo
Placebo to 300 mg CX1739

Locations

Country Name City State
United States Duke Clinical Research Unit Durham North Carolina

Sponsors (2)

Lead Sponsor Collaborator
RespireRx Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Respiratory depression Respiratory rate, tidal volume, minute volume as determined by plethysmography Sequence #1 - 30 minutes
Secondary Pain tolerance threshold Analgesia assessed by pain tolerance threshold to 5, 250, and 2000 Hertz sine-wave electrical stimulation using the quantitative sensory testing device - Neurometer Sequence #2 - 20 minutes
Secondary Maintenance of sedation Bispectral index (BIS) measure of sedation Sequence #1 - 30 minutes
Secondary The number of patients that experience an adverse drug reaction upon ingestion of CX1739 when used alone or in conjunction with remifentanil Vital signs, including noninvasive blood pressure, heart rate, RR, end-tidal carbon dioxide, pulse oximetry saturation, and temperature
Electrocardiograms
Focused physical examinations
Adverse events
up to 5 weeks
Secondary Change in pupil size Pupil size will be assessed intermittently with a noninvasive pupillometer incorporated into a pair of glasses placed on the subject's head Sequence #2 - 20 minutes