Painful Diabetic NeuropathyPhase 1NCT04857957
Safety, Tolerability & Pharmacokinetics Study of CNTX-6016 in Healthy Subjects and Subjects With PDN
A Phase 1 study of Painful Diabetic Neuropathy, run by Centrexion Therapeutics at 1 site in United States.
Trial summary
A Phase 1b study to evaluate the safety, tolerability and pharmacokinetics of multiple ascending doses of CNTX-6016 in healthy subjects and a single cohort to evaluate painful diabetic neuropathy. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Painful Diabetic Neuropathy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Apr 2021to 30 Aug 2023
- 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 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Is in good general health as determined by Investigator's review.
- Has a body mass index (BMI) between 18 and 35 kg/m2.
- Non- or ex-smoker (> 1 year) and has not used any nicotine containing products within 12 months prior to screening.
- For females, is not currently pregnant 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
- A diagnosis/history of Type 2 diabetes mellitus
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- The pain is present in both feet/legs with symmetrical onset
- The pain is characterized as burning, painful, cold or electrical shocks in nature
- The pain is associated with tingling, numbness, itching or pins and needles type sensations
- The pain has been present and consistent for ≥ 6 months
Who cannot join
- Is pregnant, lactating, or planning a pregnancy during the study.
- Tests positive for COVID-19 after screening is complete and subject is confirmed to enroll
- History of or active cardiac disease, including congestive heart failure, angina, or any arrhythmia.
- Has any history or currently active type of cancer except excised or cured basal cell carcinoma.
- 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.
- Positive urine screen for alcohol, cotinine, THC and/or drugs of abuse
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- Has positive screening test for hepatitis B virus (HBV) or hepatitis C virus (HCV).
- Diagnosis of Type 1 diabetes
- Has serious or unstable cardiovascular, hepatic, renal, respiratory or hematological illness
- Has a history or currently active type of cancer except excised or cured basal cell carcinoma.
- Has a History of psychological conditions or neurological disorders
- Has a History of lower back pain with radiculopathy
- Has received non-pharmacological treatment for pain within 14 days
- Has a history of frequent and/or severe allergic reactions with multiple medications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CNTX-6016 in Healthy Subjects and a Single Cohort of Subjects With Painful Diabetic Neuropathy
A Phase 1b study to evaluate the safety, tolerability and pharmacokinetics of multiple ascending doses of CNTX-6016 in healthy subjects and a single cohort to evaluate painful diabetic neuropathy.
- Conditions
- Painful Diabetic Neuropathy
- Being tested
- Oral dose CNTX-6016 or oral dose Placebo
- Keywords
- Painful Diabetic Neuropathy
- Medical subject headings
- Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral dose CNTX-6016 or oral dose PlaceboDrug
CNTX-6016 or Placebo
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Dose 1 Receives: Drug: Oral dose CNTX-6016 or oral dose Placebo |
| Cohort 2 | Experimental | Dose 2 Receives: Drug: Oral dose CNTX-6016 or oral dose Placebo |
| Cohort 3 | Experimental | Dose 3 Receives: Drug: Oral dose CNTX-6016 or oral dose Placebo |
| PDN cohort | Experimental | Dose based on safety in healthy Cohorts 1-3 Receives: Drug: Oral dose CNTX-6016 or oral dose Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events (TEAEs) (safety and tolerability) with CNTX-6016
Number of participants with TEAEs, which includes laboratory test variables
Measured: Up to 45 days
CNTX-6016 Pharmacokinetics - Cmax
Systemic exposure to CNTX-6016 measured by Cmax
Measured: Up to Day 6
CNTX-6016 Pharmacokinetics - AUC0-t
Systemic exposure to CNTX-6016 measured by AUC0-t
Measured: Up to Day 6
CNTX-6016 Pharmacokinetics - t1/2
Systemic exposure to CNTX-6016 measured by t1/2
Measured: Up to Day 6
CNTX-6016 Pharmacokinetics - tmax
Systemic exposure to CNTX-6016 measured by tmax
Measured: Up to Day 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2021
- Study start14 Apr 2021
- Primary completion30 Aug 2023
- Study completion30 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Painful Diabetic NeuropathyStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centrexion Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Randall Stevens, MD, Study chair, Centrexion Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04857957
- Sponsor's protocol ID
- CNTX-6016o-HV/PDN-102
- Status last verified
- Oct 2023
- First submitted
- 19 Apr 2021
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CNTX-6016 in Healthy Subjects and a Single Cohort of Subjects With Painful Diabetic Neuropathy
- ClinicalTrials.gov ID
- NCT04857957
- Acronym / sponsor ID
- CNTX-6016o-HV/PDN-102
- Conditions
- Painful Diabetic Neuropathy
- Keywords
- Painful Diabetic Neuropathy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Centrexion TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 14 Apr 2021 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 23 Apr 2021 (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 1b study to evaluate the safety, tolerability and pharmacokinetics of multiple ascending doses of CNTX-6016 in healthy subjects and a single cohort to evaluate painful diabetic neuropathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: Oral dose CNTX-6016 or oral dose PlaceboDose 1 |
| Cohort 2 | Experimental | Drug: Oral dose CNTX-6016 or oral dose PlaceboDose 2 |
| Cohort 3 | Experimental | Drug: Oral dose CNTX-6016 or oral dose PlaceboDose 3 |
| PDN cohort | Experimental | Drug: Oral dose CNTX-6016 or oral dose PlaceboDose based on safety in healthy Cohorts 1-3 |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Is in good general health as determined by Investigator's review.
- Has a body mass index (BMI) between 18 and 35 kg/m2.
- Non- or ex-smoker (> 1 year) and has not used any nicotine containing products within 12 months prior to screening.
- For females, is not currently pregnant 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 (14 listed)
- Is pregnant, lactating, or planning a pregnancy during the study.
- Tests positive for COVID-19 after screening is complete and subject is confirmed to enroll
- History of or active cardiac disease, including congestive heart failure, angina, or any arrhythmia.
- Has any history or currently active type of cancer except excised or cured basal cell carcinoma.
- 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.
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 |
|---|---|---|
| Oral dose CNTX-6016 or oral dose PlaceboCNTX-6016 or Placebo | Drug | Cohort 1, Cohort 2, Cohort 3, PDN cohort |
Primary outcome
Incidence of treatment-emergent adverse events (TEAEs) (safety and tolerability) with CNTX-6016
Time frame: Up to 45 days
Number of participants with TEAEs, which includes laboratory test variables
CNTX-6016 Pharmacokinetics - Cmax
Time frame: Up to Day 6
Systemic exposure to CNTX-6016 measured by Cmax
CNTX-6016 Pharmacokinetics - AUC0-t
Time frame: Up to Day 6
Systemic exposure to CNTX-6016 measured by AUC0-t
CNTX-6016 Pharmacokinetics - t1/2
Time frame: Up to Day 6
Systemic exposure to CNTX-6016 measured by t1/2
CNTX-6016 Pharmacokinetics - tmax
Time frame: Up to Day 6
Systemic exposure to CNTX-6016 measured by tmax
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 28 Jul 2025.
- 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.
Randall 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 of Painful Diabetic Neuropathy, 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 10 inclusion and 14 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 28 Jul 2025. 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?
Incidence of treatment-emergent adverse events (TEAEs) (safety and tolerability) with CNTX-6016 (time frame: Up to 45 days). The study lists 5 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 28 Jul 2025.