Pain, AcutePhase 1NCT04252833
Open-label, Crossover, Food Effect Study to Evaluate CT-044 in Healthy Human Volunteers
A Phase 1 study testing CT-044 in people with Pain, Acute and Acute Pain, run by Lotus Clinical Research, LLC at 1 site in United States.
Trial summary
This open-label study will be conducted to assess the bioavailability and PK of oral single doses of CT-044 following administration with and without food and to evaluate the safety and tolerability of CT-044 when given with and without food. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Acute, Acute Pain, Surgery
- What is being tested?
- CT-044
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Feb 2020to 16 Mar 2020
- Phase
- Phase 1
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men and women aged 18 through 55 years, inclusive.
- Body mass index within the range 18.5 to 32.0 kg/m2 (inclusive).
- Healthy subjects as determined by medical history, physical examination including neurological examination, vital signs, electrocardiogram (ECG), and clinical laboratory tests.
- Negative tests for hepatitis B surface antigen, hepatitis C virus antibodies and human immunodeficiency virus (HIV-1 or HIV-2) antibody, and syphilis at screening.
- Nonsmokers or ex-smokers and agrees not to use nicotine containing products from screening through 48 hours after final discharge from the Clinical Trial Unit.
- Negative screen for alcohol and drugs of abuse at screening and admission.
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- Women must not be of childbearing potential by reason of surgery or at least 1 year postmenopausal (i.e., 12 months without menstrual period), or menopause confirmed with an estradiol level of <30 pg/mL and follicle-stimulating hormone level of >40 IU/L at screening.
- Men must be infertile, or truly abstinent of heterosexual intercourse, or heterosexual partner is not of childbearing potential, or must agree to use an effective method of contraception throughout the study and for 28 days after last dose of study drug. Men must agree to not provide sperm donation during that same period.
- Able and willing to be available for the duration of the study.
- Willing and able to give written informed consent to participate.
- Able to understand and comply with protocol instructions.
- Agree not to receive any vaccination within 21 days prior to admission and through Day 7 after final discharge from the Clinical Trial Unit.
- Agrees not to use nonprescription drugs, including vitamins, antacids, and herbal and dietary supplements within 14 days or 5 drug elimination half-lives, whichever is longer.
Who cannot join
- Subjects with significant previous or ongoing disease or disorder, including for example: cardiovascular diseases; hypertension; cancer or neoplasia; diabetes; hepatic, endocrine, metabolic, respiratory, renal, gastrointestinal (except appendectomy), hematological or Axis I or II psychiatric disorders.
- Clinical laboratory test results outside the normal range at screening that are considered clinically significant by the Investigator.
- Clinically significant, in the opinion of the Investigator, infection or inflammation at time of screening or admission.
- Acute gastrointestinal symptoms at time of screening or admission or a clinical diagnosis of irritable bowel syndrome (IBS) per ROME IV criteria.
- Average QTcF interval recorded on screening and pre-dose ECG must be not more than 450 msec.
- Any current or previous illicit use of Class A drugs such as opiates, cocaine, ecstasy, lysergic acid diethylamide (LSD), and amphetamines (Class B).
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- An alcoholic intake greater than 14 units per week or unwillingness to stop alcohol consumption for the duration of the study.
- Use of any investigational medication within 3 months prior to the start of this study or scheduled to receive an investigational drug during the course of this study, or for 30 days or five half-lives, whichever is longer, following the last dose of study medication.
- History of severe allergies or multiple adverse drug reactions, including penicillin and cephalosporins.
- Any condition which compromises their ability to give informed consent or to communicate with the Investigator as required for the completion of this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Lotus Clinical Resarch,LLC
Pasadena, California, 91105
About this study
Official title: Open-label, Crossover, Food Effect Study to Evaluate the Single Dose Pharmacokinetics of CT-044, a Reactive Species Decomposition Accelerant, in Healthy Human Volunteers
This open-label study will be conducted to assess the bioavailability and PK of oral single doses of CT-044 following administration with and without food and to evaluate the safety and tolerability of CT-044 when given with and without food.
Read the detailed description
The food effect study will be an open-label, 2-sequence, balanced crossover design in 12 subjects previously untreated with CT-044.
Eligible subjects will be admitted to the Clinical Trial Unit on the day prior to dosing and remain in house until Day 3. Each subject will receive CT-044 single oral dose once under fed conditions (i.e., a high fat meal per FDA recommendations) and once in the fasted state.
9 Subjects will return to the Clinical Trial Unit on an outpatient basis for follow-up. Subjects will return to the Clinical Trial Unit to be treated by the second sequence after a washout period of at least 7 days, but no more than 14 days. All procedures will be repeated for the second treatment sequence. When possible, the procedures conducted at the 144-hour follow-up visit for the first sequence may serve as baseline for the second sequence of the crossover.
- Conditions
- Pain, Acute, Acute Pain, Surgery, Neuropathy
- Being tested
- CT-044
- Keywords
- Safety, Tolerability, Single Dose, Pharmacokinetics, PK, CT-044 HCl, Food Effect
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-044Drug
CT-044 HCl is a reactive species decomposition accelerant
| Study group | Role | What they receive |
|---|---|---|
| CT-044 600 mg | Experimental | The dose to be utilized for the evaluation of food effect will be CT-044 600 mg single dose. Receives: Drug: CT-044 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the maximum drug concentration
Following administration with and without food (Cmax) of oral single dose of CT-044
Measured: 7 days
Comparison of the Time of maximum drug concentration (tmax)
Following a single oral dose of CT-044 following administration with and without food
Measured: 7 days
Comparison of the Area under the drug concentration Time curve from time 0 extrapolated to infinity (AUC0-∞)
Following a single oral dose of CT-044 following administration with and without food
Measured: 7 days
Comparison of the Area under the drug concentration Time curve from time 0 to the time of the last quantifiable concentration (AUC0-last)
Following a single oral dose of CT-044 following administration with and without food
Measured: 7 days
Comparison of the Apparent oral clearance (CL/F)
Following a single oral dose of CT-044 following administration with and without food
Measured: 7 days
Comparison of the Apparent volume distribution (Vz/F)
Following a single oral dose of CT-044 following administration with and without food
Measured: 7 days
Comparison of the Terminal half-life (t1/2)
Following a single oral dose of CT-044 following administration with and without food
Measured: 7 days
Comparison of the Terminal rate constant (λz)
Following a single oral dose of CT-044 following administration with and without food
Measured: 7 days
Comparison of the Relative bioavailability
Following a single oral dose of CT-044 after administration of a high-fat meal (F)
Measured: 7 days
Peak Plasma Concentration (Cmax)
Linear mixed model appropriate for a 2-period cross-over design with fixed terms for sequence, period and food condition will be used to investigate the food interaction on the Peak Plasma Concentration (Cmax)
Measured: 7 days
Plasma concentration versus time curve (AUC)
Linear mixed model appropriate for a 2-period cross-over design with fixed terms for sequence, period and food condition will be used to investigate the food interaction Area under the plasma concentration versus time curve (AUC)
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start18 Feb 2020
- Primary completion16 Mar 2020
- Study completion16 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, AcuteStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The dose to be utilized for the evaluation of food effect will be CT-044 600 mg single dose.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lotus Clinical Research, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- CerSci Therapeutics
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04252833
- Sponsor's protocol ID
- CT044-003
- Status last verified
- Jun 2020
- First submitted
- 3 Dec 2019
- Last updated
- 12 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Squillace S, Salvemini D. Nitroxidative stress in pain and opioid-induced adverse effects: therapeutic opportunities. Pain. 2022 Feb 1;163(2):205-213. doi: 10.1097/j.pain.0000000000002347. No abstract available.
PubMed 34145168
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Crossover, Food Effect Study to Evaluate the Single Dose Pharmacokinetics of CT-044, a Reactive Species Decomposition Accelerant, in Healthy Human Volunteers
- ClinicalTrials.gov ID
- NCT04252833
- Acronym / sponsor ID
- CT044-003
- Conditions
- Pain, Acute, Acute Pain, Surgery, Neuropathy
- Keywords
- Safety, Tolerability, Single Dose, Pharmacokinetics, PK, CT-044 HCl, Food Effect
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Lotus Clinical Research, LLCUniversity, hospital or other
- Collaborators
- CerSci Therapeutics
- Study start
- 18 Feb 2020 (actual)
- Primary completion
- 16 Mar 2020 (actual)
- Study completion
- 16 Mar 2020 (actual)
- First posted
- 5 Feb 2020 (actual)
- 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.
This open-label study will be conducted to assess the bioavailability and PK of oral single doses of CT-044 following administration with and without food and to evaluate the safety and tolerability of CT-044 when given with and without food.
Detailed description
The food effect study will be an open-label, 2-sequence, balanced crossover design in 12 subjects previously untreated with CT-044.
Eligible subjects will be admitted to the Clinical Trial Unit on the day prior to dosing and remain in house until Day 3. Each subject will receive CT-044 single oral dose once under fed conditions (i.e., a high fat meal per FDA recommendations) and once in the fasted state.
9 Subjects will return to the Clinical Trial Unit on an outpatient basis for follow-up. Subjects will return to the Clinical Trial Unit to be treated by the second sequence after a washout period of at least 7 days, but no more than 14 days. All procedures will be repeated for the second treatment sequence. When possible, the procedures conducted at the 144-hour follow-up visit for the first sequence may serve as baseline for the second sequence of the crossover.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The dose to be utilized for the evaluation of food effect will be CT-044 600 mg single dose.
| Arm | Type | Receives |
|---|---|---|
| CT-044 600 mg | Experimental | Drug: CT-044The dose to be utilized for the evaluation of food effect will be CT-044 600 mg single dose. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Men and women aged 18 through 55 years, inclusive.
- Body mass index within the range 18.5 to 32.0 kg/m2 (inclusive).
- Healthy subjects as determined by medical history, physical examination including neurological examination, vital signs, electrocardiogram (ECG), and clinical laboratory tests.
- Negative tests for hepatitis B surface antigen, hepatitis C virus antibodies and human immunodeficiency virus (HIV-1 or HIV-2) antibody, and syphilis at screening.
- Nonsmokers or ex-smokers and agrees not to use nicotine containing products from screening through 48 hours after final discharge from the Clinical Trial Unit.
Key exclusion criteria (10 listed)
- Subjects with significant previous or ongoing disease or disorder, including for example: cardiovascular diseases; hypertension; cancer or neoplasia; diabetes; hepatic, endocrine, metabolic, respiratory, renal, gastrointestinal (except appendectomy), hematological or Axis I or II psychiatric disorders.
- Clinical laboratory test results outside the normal range at screening that are considered clinically significant by the Investigator.
- Clinically significant, in the opinion of the Investigator, infection or inflammation at time of screening or admission.
- Acute gastrointestinal symptoms at time of screening or admission or a clinical diagnosis of irritable bowel syndrome (IBS) per ROME IV criteria.
- Average QTcF interval recorded on screening and pre-dose ECG must be not more than 450 msec.
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 |
|---|---|---|
| CT-044CT-044 HCl is a reactive species decomposition accelerant | Drug | CT-044 600 mg |
Primary outcome
Comparison of the maximum drug concentration
Time frame: 7 days
Following administration with and without food (Cmax) of oral single dose of CT-044
Comparison of the Time of maximum drug concentration (tmax)
Time frame: 7 days
Following a single oral dose of CT-044 following administration with and without food
Comparison of the Area under the drug concentration Time curve from time 0 extrapolated to infinity (AUC0-∞)
Time frame: 7 days
Following a single oral dose of CT-044 following administration with and without food
Comparison of the Area under the drug concentration Time curve from time 0 to the time of the last quantifiable concentration (AUC0-last)
Time frame: 7 days
Following a single oral dose of CT-044 following administration with and without food
Comparison of the Apparent oral clearance (CL/F)
Time frame: 7 days
Following a single oral dose of CT-044 following administration with and without food
Comparison of the Apparent volume distribution (Vz/F)
Time frame: 7 days
Following a single oral dose of CT-044 following administration with and without food
Comparison of the Terminal half-life (t1/2)
Time frame: 7 days
Following a single oral dose of CT-044 following administration with and without food
Comparison of the Terminal rate constant (λz)
Time frame: 7 days
Following a single oral dose of CT-044 following administration with and without food
Comparison of the Relative bioavailability
Time frame: 7 days
Following a single oral dose of CT-044 after administration of a high-fat meal (F)
Peak Plasma Concentration (Cmax)
Time frame: 7 days
Linear mixed model appropriate for a 2-period cross-over design with fixed terms for sequence, period and food condition will be used to investigate the food interaction on the Peak Plasma Concentration (Cmax)
Plasma concentration versus time curve (AUC)
Time frame: 7 days
Linear mixed model appropriate for a 2-period cross-over design with fixed terms for sequence, period and food condition will be used to investigate the food interaction Area under the plasma concentration versus time curve (AUC)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2020.
- Derived from this study: PubMed 34145168Squillace S, Salvemini D. Nitroxidative stress in pain and opioid-induced adverse effects: therapeutic opportunities. Pain. 2022 Feb 1;163(2):205-213. doi: 10.1097/j.pain.0000000000002347. No abstract available.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CT-044 in people with Pain, Acute and Acute Pain, run by Lotus Clinical Research, LLC 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 13 inclusion and 10 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: finished, as of the sponsor's last update on 12 Jun 2020. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Comparison of the maximum drug concentration (time frame: 7 days). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04252833, which also lists 1 linked publication.
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 12 Jun 2020.