Opiate Induced Respiratory DepressionPhase 2NCT02735629
Antagonism of Opioid-Induced Respiratory Depression by CX1739 With Preservation of Opioid Analgesia
A Phase 2 study testing CX1739 - 300 mg, CX1739 - 600 mg and CX1739 - 900 mg in people with Opiate Induced Respiratory Depression, run by RespireRx at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Opiate Induced Respiratory Depression
- What is being tested?
- CX1739 - 300 mg, CX1739 - 600 mg and CX1739 - 900 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to Sep 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Clinical Research Unit
Durham, North Carolina, 27710
About this study
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
- Being tested
- CX1739 - 300 mg, CX1739 - 600 mg, CX1739 - 900 mg, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CX1739 - 300 mgDrug
Also called Low dose
Ampakine CX1739 - 300 mg
CX1739 - 600 mgDrug
Also called mid dose
CX1739 - 600 mg
CX1739 - 900 mgDrug
Also called high dose
CX1739 - 900 mg
PlaceboDrug
Also called Placebo to 300 mg CX1739
Placebo to 300 mg CX1739
| Study group | Role | What they receive |
|---|---|---|
| CX1739 - 300 mg | Experimental | Study Drug - low dose Receives: Drug: CX1739 - 300 mg |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
| CX1739 - 600 mg | Experimental | Study drug - mid Dose Receives: Drug: CX1739 - 600 mg |
| CX1739 - 900 mg | Experimental | Study drug - high dose Receives: Drug: CX1739 - 900 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory depression
Respiratory rate, tidal volume, minute volume as determined by plethysmography
Measured: Sequence #1 - 30 minutes
Secondary outcomes (4)
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
Measured: Sequence #2 - 20 minutes
Maintenance of sedation
Bispectral index (BIS) measure of sedation
Measured: 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
Vital signs, including noninvasive blood pressure, heart rate, RR, end-tidal carbon dioxide, pulse oximetry saturation, and temperature
- Electrocardiograms
- Focused physical examinations
- Adverse events
Measured: up to 5 weeks
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
Measured: Sequence #2 - 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2016 (estimated)
- Study startMar 2016
- Primary completionAug 2016 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opiate Induced Respiratory DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- RespireRx
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Duke University
- Responsible party
- Sponsor
- Investigators
- Richard Purcell, Study director, RespireRx Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02735629
- Sponsor's protocol ID
- CRTX-05
- Status last verified
- Jul 2016
- First submitted
- 23 Mar 2016
- Last updated
- 28 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antagonism of Opioid-Induced Respiratory Depression by CX1739 With Preservation of Opioid Analgesia
- ClinicalTrials.gov ID
- NCT02735629
- Acronym / sponsor ID
- CRTX-05
- Conditions
- Opiate Induced Respiratory Depression
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (actual)
- Lead sponsor
- RespireRxIndustry (pharma, biotech, devices)
- Collaborators
- Duke University
- Study start
- Mar 2016
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 13 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CX1739 - 300 mg | Experimental | Drug: CX1739 - 300 mgStudy Drug - low dose |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
| CX1739 - 600 mg | Experimental | Drug: CX1739 - 600 mgStudy drug - mid Dose |
| CX1739 - 900 mg | Experimental | Drug: CX1739 - 900 mgStudy drug - high dose |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- To be eligible for this trial, subjects must meet all of the following criteria:
Key exclusion criteria (16 listed)
- If a subject meets any of the following criteria, he cannot be enrolled in the study:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CX1739 - 300 mgAlso: Low doseAmpakine CX1739 - 300 mg | Drug | CX1739 - 300 mg |
| CX1739 - 600 mgAlso: mid doseCX1739 - 600 mg | Drug | CX1739 - 600 mg |
| CX1739 - 900 mgAlso: high doseCX1739 - 900 mg | Drug | CX1739 - 900 mg |
| PlaceboAlso: Placebo to 300 mg CX1739Placebo to 300 mg CX1739 | Drug | Placebo |
Primary outcome
Respiratory depression
Time frame: Sequence #1 - 30 minutes
Respiratory rate, tidal volume, minute volume as determined by plethysmography
4 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2016.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Purcell study director
RespireRx Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CX1739 - 300 mg, CX1739 - 600 mg and CX1739 - 900 mg in people with Opiate Induced Respiratory Depression, run by RespireRx at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory depression (time frame: Sequence #1 - 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2016.