RespireRx Pharmaceuticals Inc (RSPI)

[gfp927z]

The CX-1739 RD trial is recruiting according to the Clinicaltrials.gov site -



https://clinicaltrials.gov/ct2/show/NCT02735629?term=respirerx&rank=1



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



This study is currently recruiting participants. (see Contacts and Locations)

Verified April 2016 by RespireRx

Sponsor:

RespireRx

Collaborator:

Duke University

Information provided by (Responsible Party):

RespireRx


ClinicalTrials.gov Identifier:

NCT02735629

First received: March 23, 2016

Last updated: April 6, 2016

Last verified: April 2016

History of Changes

Full Text View
Tabular View
No Study Results Posted
Disclaimer
How to Read a Study Record

Purpose

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.




Condition

Intervention

Phase

Opiate Induced Respiratory Depression
Drug: CX1739 - 300 mg
Drug: CX1739 - 600 mg
Drug: CX1739 - 900 mg
Drug: Placebo
Phase 2







Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Antagonism of Opioid-Induced Respiratory Depression by CX1739 With Preservation of Opioid Analgesia


Further study details as provided by RespireRx:



Primary Outcome Measures: •Respiratory depression [ Time Frame: Sequence #1 - 30 minutes ] [ Designated as safety issue: No ]
Respiratory rate, tidal volume, minute volume as determined by plethysmography




Secondary Outcome Measures: •Pain tolerance threshold [ Time Frame: Sequence #2 - 20 minutes ] [ Designated as safety issue: No ]
Analgesia assessed by pain tolerance threshold to 5, 250, and 2000 Hertz sine-wave electrical stimulation using the quantitative sensory testing device - Neurometer


•Maintenance of sedation [ Time Frame: Sequence #1 - 30 minutes ] [ Designated as safety issue: No ]
Bispectral index (BIS) measure of sedation


•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 ] [ Designated as safety issue: Yes ]
Vital signs, including noninvasive blood pressure, heart rate, RR, end-tidal carbon dioxide, pulse oximetry saturation, and temperature
?Electrocardiograms
?Focused physical examinations
?Adverse events


•Change in pupil size [ Time Frame: Sequence #2 - 20 minutes ] [ Designated as safety issue: No ]
Pupil size will be assessed intermittently with a noninvasive pupillometer incorporated into a pair of glasses placed on the subject's head








Estimated Enrollment: 18
Study Start Date: March 2016
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)



Arms

Assigned Interventions

Experimental: CX1739 - 300 mg
Study Drug - low dose
Drug: CX1739 - 300 mg
Ampakine CX1739 - 300 mg

Other Name: Low dose

Placebo Comparator: Placebo
Placebo
Drug: Placebo
Placebo to 300 mg CX1739

Experimental: CX1739 - 600 mg
Study drug - mid Dose
Drug: CX1739 - 600 mg
CX1739 - 600 mg

Other Name: mid dose

Experimental: CX1739 - 900 mg
Study drug - high dose
Drug: CX1739 - 900 mg
CX1739 - 900 mg

Other Name: high dose



Eligibility







Ages Eligible for Study: 18 Years to 50 Years
Genders Eligible for Study: Male
Accepts Healthy Volunteers: Yes

Criteria


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


Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02735629


Contacts







Contact: Richard Purcell 732-492-1797 [e-mail]


Locations





United States, North Carolina
Duke Clinical Research Unit Recruiting
Durham, North Carolina, United States, 27710
Contact: David MacLeod, MB, BS, FRCA 919-681-3551 [e-mail]
Principal Investigator: David MacLeod, MB, BS, FRCA
Principal Investigator: Andrew Krystal, MD

Sponsors and Collaborators

RespireRx

Duke University

Investigators







Study Director: Richard Purcell RespireRx Pharmaceuticals

More Information






Responsible Party: RespireRx
ClinicalTrials.gov Identifier: NCT02735629 History of Changes
Other Study ID Numbers: CRTX-05
Study First Received: March 23, 2016
Last Updated: April 6, 2016
Health Authority: United States: Food and Drug Administration


Additional relevant MeSH terms:





Depression
Depressive Disorder
Respiratory Insufficiency
Behavioral Symptoms
Mental Disorders
Mood Disorders
Respiration Disorders
Respiratory Tract Diseases


ClinicalTrials.gov processed this record on May 02, 2016

<<<