Chronic PainPhase 1NCT03787004
A Placebo-Controlled, Two-Part Study, Oral Dose to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of CNTX-6970 in Healthy Subjects
A Phase 1 study testing CNTX-6970 in people with Chronic Pain and Nociceptive Pain, run by Centrexion Therapeutics at 1 site in United States.
Trial summary
A Phase 1, placebo-controlled, two part study with either single dose or multiple increasing oral dose to evaluate the safety, pharmacokinetics, and pharmacodynamics of CNTX-6970 in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain, Nociceptive Pain
- What is being tested?
- CNTX-6970
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2017to 26 Sep 2018
- 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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Is in good general health as determined by the Investigator's review
- Has a body mass index (BMI) between 18 and 35kg/m^2, inclusive
- For females, is not currently pregnant or breastfeeding and is either of non-childbearing potential or willing to use an adequate method of birth control
- For males, must agree to use barrier contraception and not to donate sperm
Who cannot join
- Has a history of cardiac disease, including congestive heart failure, angina, or any arrhythmia
- Has diabetes mellitus, acromegaly, clinically active thyroid disease, or other active endocrinopathy
- Has any history or currently active type of cancer except excised or cured basal cell carcinoma
- Has a gastrointestinal disorder that could interfere with the absorption of orally administered drugs
- Has asthma or other severe respiratory disease (e.g., chronic obstructive pulmonary disease) requiring daily prescription medicine
- Currently has kidney, neurologic, metabolic, or liver disease, or other organ system disease
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- Has a history, current evidence, or is being treated for depression, suicidal ideation, suicide attempt, or any other current psychiatric condition requiring active treatment
- Has an immunological disorder such as, but not limited to, human immunodeficiency virus (HIV), acquired, or congenital immune deficiency syndrome; autoimmune diseases, such as, but not limited to, rheumatoid arthritis, systemic lupus erythematosus, seronegative spondyloarthropathies or vasculitis, or any infection
- Has positive screening test for hepatitis B virus (HBV) or hepatitis C virus (HCV);
- Is pregnant, lactating, or planning a pregnancy during the study
- Has used any prescribed medication within 30 days prior to the first admission or has plans to use any prescribed medication during the study (with the exception of hormonal contraceptives)
- Has used within 14 days prior to the first admission or has plans to use during the study any over-the-counter medicinal products, including herbal and dietary supplements (except for occasional use of acetaminophen or NSAIDs, such as ibuprofen or naproxen; calcium; or Vitamin D)
- Use of any of the following:
- Human growth hormone, octreotide, anti-diabetic medication, or thyroid suppressors or supplements
- Immunosuppressive drugs within 30 days of study start, or 5 half-lives of the drug (whichever is longer), or plans to use during the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Medpace Clinical Pharmacology Unit
Cincinnati, Ohio, 45227
About this study
Official title: A Placebo-Controlled, Two-Part Study With Single Dose and Multiple Ascending Oral Dose to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of CNTX-6970 in Healthy Subjects
A Phase 1, placebo-controlled, two part study with either single dose or multiple increasing oral dose to evaluate the safety, pharmacokinetics, and pharmacodynamics of CNTX-6970 in healthy subjects.
- Conditions
- Chronic Pain, Nociceptive Pain
- Being tested
- CNTX-6970, Placebo
- Keywords
- Chronic Pain, Nociceptive Pain, Mixed Pain
- Medical subject headings
- Chronic Pain, Nociceptive Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CNTX-6970Drug
Oral dose CNTX-6970
PlaceboOther
Oral dose placebo
| Study group | Role | What they receive |
|---|---|---|
| Part 1 Cohort 1 (Single Dose) | Experimental | Single 100 mg oral dose of CNTX-6970 (film-coated tablet or enteric-coated tablet) Receives: Drug: CNTX-6970 |
| Part 1 Cohort 2 (Single Dose) | Experimental | Single 100 mg oral dose of CNTX-6970 film-coated tablet Receives: Drug: CNTX-6970 |
| Part 2 (Multiple Ascending Dose) | Experimental | 100 mg, 300 mg, and 600 mg CNTX-6970 oral tablet Receives: Drug: CNTX-6970 |
| Part 2 Placebo | Placebo comparator | Placebo oral tablet Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
CNTX-6970 Pharmacokinetics - fasted state or high-fat standardized meal
Food effects on pharmacokinetics of CTNX-6790 for Part 1 participants
Measured: Up to Day 3
CNTX-6970 Pharmacokinetics - AUC0-t
Systemic exposure to CNTX-6970 measured by AUC0-t
Measured: Up to Day 13
CNTX-6970 Pharmacokinetics - AUC0-inf
Systemic exposure to CNTX-6970 measured by AUC0-inf
Measured: Up to Day 13
CNTX-6970 Pharmacokinetics - Cmax
Systemic exposure to CNTX-6970 measured by Cmax
Measured: Up to Day 13
CNTX-6970 Pharmacokinetics - tmax
Systemic exposure to CNTX-6970 measured by tmax
Measured: Up to Day 13
CNTX-6970 Pharmacokinetics - t1/2
Systemic exposure to CNTX-6970 measured by t1/2
Measured: Up to Day 13
Secondary outcomes (3)
Incidence of treatment-emergent adverse events (TEAEs) (safety and tolerability)
Number of participants with TEAEs, which includes laboratory test variables
Measured: Up to Day 13
CNTX-6970 Pharmacodynamics - Emax
Pharmacodynamic effect on MCP-1 and RANTES measured by Emax
Measured: Up to Day 13
CNTX-6970 Pharmacodynamics - PD tmax
Time to maximum pharmacodynamic effect on MCP-1 and RANTES measured by tmax
Measured: Up to Day 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2018
- Study start14 Aug 2017
- Primary completion19 Aug 2018
- Study completion26 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centrexion Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Randall M. Stevens, MD, Study chair, Centrexion Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03787004
- Sponsor's protocol ID
- CNTX-6970-HV-102
- Status last verified
- Dec 2018
- First submitted
- 21 Dec 2018
- Last updated
- 26 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo-Controlled, Two-Part Study With Single Dose and Multiple Ascending Oral Dose to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of CNTX-6970 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03787004
- Acronym / sponsor ID
- CNTX-6970-HV-102
- Conditions
- Chronic Pain, Nociceptive Pain
- Keywords
- Chronic Pain, Nociceptive Pain, Mixed Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Centrexion TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 14 Aug 2017 (actual)
- Primary completion
- 19 Aug 2018 (actual)
- Study completion
- 26 Sep 2018 (actual)
- First posted
- 26 Dec 2018 (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.
A Phase 1, placebo-controlled, two part study with either single dose or multiple increasing oral dose to evaluate the safety, pharmacokinetics, and pharmacodynamics of CNTX-6970 in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part 1 Cohort 1 (Single Dose) | Experimental | Drug: CNTX-6970Single 100 mg oral dose of CNTX-6970 (film-coated tablet or enteric-coated tablet) |
| Part 1 Cohort 2 (Single Dose) | Experimental | Drug: CNTX-6970Single 100 mg oral dose of CNTX-6970 film-coated tablet |
| Part 2 (Multiple Ascending Dose) | Experimental | Drug: CNTX-6970100 mg, 300 mg, and 600 mg CNTX-6970 oral tablet |
| Part 2 Placebo | Placebo comparator | Other: PlaceboPlacebo oral tablet |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Is in good general health as determined by the Investigator's review
- Has a body mass index (BMI) between 18 and 35kg/m^2, inclusive
- For females, is not currently pregnant or breastfeeding and is either of non-childbearing potential or willing to use an adequate method of birth control
- For males, must agree to use barrier contraception and not to donate sperm
Key exclusion criteria (15 listed)
- Has a history of cardiac disease, including congestive heart failure, angina, or any arrhythmia
- Has diabetes mellitus, acromegaly, clinically active thyroid disease, or other active endocrinopathy
- Has any history or currently active type of cancer except excised or cured basal cell carcinoma
- Has a gastrointestinal disorder that could interfere with the absorption of orally administered drugs
- Has asthma or other severe respiratory disease (e.g., chronic obstructive pulmonary disease) requiring daily prescription medicine
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 |
|---|---|---|
| CNTX-6970Oral dose CNTX-6970 | Drug | Part 1 Cohort 1 (Single Dose), Part 1 Cohort 2 (Single Dose), Part 2 (Multiple Ascending Dose) |
| PlaceboOral dose placebo | Other | Part 2 Placebo |
Primary outcome
CNTX-6970 Pharmacokinetics - fasted state or high-fat standardized meal
Time frame: Up to Day 3
Food effects on pharmacokinetics of CTNX-6790 for Part 1 participants
CNTX-6970 Pharmacokinetics - AUC0-t
Time frame: Up to Day 13
Systemic exposure to CNTX-6970 measured by AUC0-t
CNTX-6970 Pharmacokinetics - AUC0-inf
Time frame: Up to Day 13
Systemic exposure to CNTX-6970 measured by AUC0-inf
CNTX-6970 Pharmacokinetics - Cmax
Time frame: Up to Day 13
Systemic exposure to CNTX-6970 measured by Cmax
CNTX-6970 Pharmacokinetics - tmax
Time frame: Up to Day 13
Systemic exposure to CNTX-6970 measured by tmax
CNTX-6970 Pharmacokinetics - t1/2
Time frame: Up to Day 13
Systemic exposure to CNTX-6970 measured by t1/2
3 secondary outcomes
Incidence of treatment-emergent adverse events (TEAEs) (safety and tolerability)
Time frame: Up to Day 13
CNTX-6970 Pharmacodynamics - Emax
Time frame: Up to Day 13
CNTX-6970 Pharmacodynamics - PD tmax
Time frame: Up to Day 13
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 26 Dec 2018.
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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.
Randall M. Stevens, MD study chair
Centrexion Therapeutics
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 CNTX-6970 in people with Chronic Pain and Nociceptive Pain, run by Centrexion Therapeutics 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 4 inclusion and 15 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 26 Dec 2018. 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 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?
CNTX-6970 Pharmacokinetics - fasted state or high-fat standardized meal (time frame: Up to Day 3). The study lists 6 primary outcomes in all. 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 26 Dec 2018.