Chronic PainPhase 1NCT04154501
A Study to Evaluate the Safety and Pharmacokinetics of CNTX-6016 in Healthy Subjects
A Phase 1 study testing CNTX-6016 in people with Chronic Pain and Nociceptive Pain, run by Centrexion Therapeutics at 1 site in United States.
Trial summary
A Phase 1 double-blind, placebo-controlled, randomized single ascending dose incorporating an open-label, 2-period crossover, food effect cohort. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain, Nociceptive Pain, Pain
- What is being tested?
- CNTX-6016
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Dec 2018to 26 Aug 2019
- 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
- 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.
Who cannot join
- 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 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.
- Has a history, current evidence, or is being treated for depression, suicidal ideation, suicide attempt, or any other current psychiatric condition requiring active treatment.
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- 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).
- Positive urine screen for alcohol, cotinine, THC and/or drugs of abuse.
- Ingestion of food or beverages containing grapefruit and/or grapefruit juice and/or pomelos during the 7 days prior to dosing and/or during the study period.
Trial locations and contacts
1 site in 1 country.
United States1 site
Altasciences Clinical Research
Overland Park, Kansas, 66212
About this study
Official title: A Study to Evaluate the Safety and Pharmacokinetics of Single Doses of CNTX-6016 in Healthy Subjects
A Phase 1 double-blind, placebo-controlled, randomized single ascending dose incorporating an open-label, 2-period crossover, food effect cohort.
- Conditions
- Chronic Pain, Nociceptive Pain, Pain
- Being tested
- CNTX-6016, Other: Placebo
- Keywords
- Chronic Pain, Nociceptive Pain, Mixed Pain, Cannabinoid, Cannabinoid-2 Receptor Agonist
- Medical subject headings
- Chronic Pain, Nociceptive Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CNTX-6016Drug
Oral Dose CNTX-6016
Other: PlaceboOther
Oral Dose Placebo
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 Placebo | Placebo comparator | Oral Placebo Capsule Receives: Other: Other: Placebo |
| Cohort 1 Drug | Experimental | 25 mg Oral Capsule Receives: Drug: CNTX-6016 |
| Cohort 2 Placebo | Placebo comparator | Oral Placebo Capsule Receives: Other: Other: Placebo |
| Cohort 2 Drug | Experimental | 50 mg Oral Capsule Receives: Drug: CNTX-6016 |
| Cohort 3 Placebo | Placebo comparator | Oral Placebo Capsule Receives: Other: Other: Placebo |
| Cohort 3 Drug | Experimental | 100 mg Oral Capsule Receives: Drug: CNTX-6016 |
| Cohort 4 Placebo | Placebo comparator | Oral Placebo Capsule Receives: Other: Other: Placebo |
| Cohort 4 Drug | Experimental | 300 mg Oral Capsule Receives: Drug: CNTX-6016 |
| Cohort 5 Placebo | Placebo comparator | Oral Placebo Capsule Receives: Other: Other: Placebo |
| Cohort 5 Drug | Experimental | 450 mg Oral Capsule Receives: Drug: CNTX-6016 |
| Cohort 6 Placebo | Placebo comparator | Oral Placebo Capsule Receives: Other: Other: Placebo |
| Cohort 6 Drug | Experimental | 600 mg Oral Capsule Receives: Drug: CNTX-6016 |
| Cohort 7 Placebo | Placebo comparator | Oral Placebo Capsule Receives: Other: Other: Placebo |
| Cohort 7 Drug | Experimental | 800 mg Oral Capsule Receives: Drug: CNTX-6016 |
| Cohort 9 Placebo | Placebo comparator | Oral Placebo Capsule Receives: Other: Other: Placebo |
| Cohort 9 Drug | Experimental | 1000 mg Oral Capsule Receives: Drug: CNTX-6016 |
| Cohort 8 Fasted | Experimental | Participant will take 300 mg Oral Capsule in a fasting state, and then fed state. Receives: Drug: CNTX-6016 |
| Cohort 8 Fed | Experimental | Participant will take 300 mg Oral Capsule in a fed state, and then fasting state. Receives: Drug: CNTX-6016 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of single doses of CNTX-6016 - TEAEs
Information regarding treatment emergent adverse events was collected during each dose cohort.
Measured: Up to 80 days
Dose Proportionality of a single doses of CNTX-6016 in healthy subjects
Dose Proportionality of a single doses of CNTX-6016 in healthy subjects.
Measured: 40 days
CNTX-6016 Pharmacokinetics - Cmax
Systemic exposure to CNTX-6016 measured by Cmax.
Measured: Up to 40 days
CNTX-6016 Pharmacokinetics - Tmax
Systemic exposure to CNTX-6016 measured by Tmax.
Measured: Up to 40 days
CNTX-6016 Pharmacokinetics - t1/2
Systemic exposure to CNTX-6016 measured by t1/2.
Measured: Up to 40 days
CNTX-6016 Pharmacokinetics - AUC 0-t
Systemic exposure to CNTX-6016 measured by AUC 0-t.
Measured: Up to 40 days
CNTX-6016 Pharmacokinetics - AUC 0-inf
Systemic exposure to CNTX-6016 measured by AUC 0-inf.
Measured: Up to 40 days
CNTX-6016 Pharmacokinetics - AUC 0-t/inf
Systemic exposure to CNTX-6016 measured by AUC 0-t/inf.
Measured: Up to 40 days
CNTX-6016 Pharmacokinetics - CL/F
Systemic exposure to CNTX-6016 measured by CL/F.
Measured: Up to 40 days
CNTX-6016 Pharmacokinetics - Vz/F
Systemic exposure to CNTX-6016 measured by Vz/F.
Measured: Up to 40 days
Effect of Gender on CNTX-6016 Pharmacokinetics - Cmax
Effect of Gender on the systemic exposure to CNTX-6016 measured by Cmax.
Measured: Up to 80 days
Effect of Gender on CNTX-6016 Pharmacokinetics - Tmax
Effect of Gender on the systemic exposure to CNTX-6016 measured by tmax.
Measured: Up to 80 days
Effect of Gender on CNTX-6016 Pharmacokinetics - t1/2
Effect of Gender on the systemic exposure to CNTX-6016 measured by t1/2
Measured: Up to 80 days
Effect of Gender on CNTX-6016 Pharmacokinetics - AUC
Effect of Gender on the systemic exposure to CNTX-6016 measured by AUC.
Measured: Up to 80 days
Effect of Fasted or Fed State on CNTX-6016 Pharmacokinetics - Cmax
Systemic exposure to CNTX-6016 in fasted or fed state as measured by Cmax
Measured: Up to 40 days
Effect of Fasted or Fed State on CNTX-6016 Pharmacokinetics - Tmax
Systemic exposure to CNTX-6016 in fasted or fed state as measured by Tmax
Measured: Up to 40 days
Effect of Fasted or Fed State on CNTX-6016 Pharmacokinetics - t1/2
Systemic exposure to CNTX-6016 in fasted or fed state as measured by t1/2
Measured: Up to 40 days
Effect of Fasted or Fed State on CNTX-6016 Pharmacokinetics - AUC
Systemic exposure to CNTX-6016 in fasted or fed state as measured by AUC
Measured: Up to 40 days
Urinary Excretion
Urine was collected over a 3-day period (0-72 hrs) in Cohort 8 and analyzed for concentrations of CNTX-6016 in subjects in both the fasted and fed states using Liquid Chromatography Mass Spectrometry.
Measured: Up to 6 days
Secondary outcomes (1)
Plasma and Urine Metabolite Mining
Urine was collected over a 3-day period (0-72hrs) in Cohort 9 (1000mg) and analyzed for concentrations of parent and metabolites of CNTX-6016 using Liquid Chromatography Mass Spectrometry.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2019
- Study start4 Dec 2018
- Primary completion21 Aug 2019
- Study completion26 Aug 2019
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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 68 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
- NCT04154501
- Sponsor's protocol ID
- CNTX-6016o-HV-101
- Status last verified
- Nov 2019
- First submitted
- 7 Oct 2019
- Last updated
- 6 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Safety and Pharmacokinetics of Single Doses of CNTX-6016 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04154501
- Acronym / sponsor ID
- CNTX-6016o-HV-101
- Conditions
- Chronic Pain, Nociceptive Pain, Pain
- Keywords
- Chronic Pain, Nociceptive Pain, Mixed Pain, Cannabinoid, Cannabinoid-2 Receptor Agonist
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Centrexion TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 4 Dec 2018 (actual)
- Primary completion
- 21 Aug 2019 (actual)
- Study completion
- 26 Aug 2019 (actual)
- First posted
- 6 Nov 2019 (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 double-blind, placebo-controlled, randomized single ascending dose incorporating an open-label, 2-period crossover, food effect cohort.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 18
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 Placebo | Placebo comparator | Other: Other: PlaceboOral Placebo Capsule |
| Cohort 1 Drug | Experimental | Drug: CNTX-601625 mg Oral Capsule |
| Cohort 2 Placebo | Placebo comparator | Other: Other: PlaceboOral Placebo Capsule |
| Cohort 2 Drug | Experimental | Drug: CNTX-601650 mg Oral Capsule |
| Cohort 3 Placebo | Placebo comparator | Other: Other: PlaceboOral Placebo Capsule |
| Cohort 3 Drug | Experimental | Drug: CNTX-6016100 mg Oral Capsule |
| Cohort 4 Placebo | Placebo comparator | Other: Other: PlaceboOral Placebo Capsule |
| Cohort 4 Drug | Experimental | Drug: CNTX-6016300 mg Oral Capsule |
| Cohort 5 Placebo | Placebo comparator | Other: Other: PlaceboOral Placebo Capsule |
| Cohort 5 Drug | Experimental | Drug: CNTX-6016450 mg Oral Capsule |
| Cohort 6 Placebo | Placebo comparator | Other: Other: PlaceboOral Placebo Capsule |
| Cohort 6 Drug | Experimental | Drug: CNTX-6016600 mg Oral Capsule |
| Cohort 7 Placebo | Placebo comparator | Other: Other: PlaceboOral Placebo Capsule |
| Cohort 7 Drug | Experimental | Drug: CNTX-6016800 mg Oral Capsule |
| Cohort 9 Placebo | Placebo comparator | Other: Other: PlaceboOral Placebo Capsule |
| Cohort 9 Drug | Experimental | Drug: CNTX-60161000 mg Oral Capsule |
| Cohort 8 Fasted | Experimental | Drug: CNTX-6016Participant will take 300 mg Oral Capsule in a fasting state, and then fed state. |
| Cohort 8 Fed | Experimental | Drug: CNTX-6016Participant will take 300 mg Oral Capsule in a fed state, and then fasting state. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 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 (12 listed)
- 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 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.
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-6016Oral Dose CNTX-6016 | Drug | Cohort 1 Drug, Cohort 2 Drug, Cohort 3 Drug, Cohort 4 Drug, Cohort 5 Drug, Cohort 6 Drug, Cohort 7 Drug, Cohort 8 Fasted, Cohort 8 Fed, Cohort 9 Drug |
| Other: PlaceboOral Dose Placebo | Other | Cohort 1 Placebo, Cohort 2 Placebo, Cohort 3 Placebo, Cohort 4 Placebo, Cohort 5 Placebo, Cohort 6 Placebo, Cohort 7 Placebo, Cohort 9 Placebo |
Primary outcome
Safety of single doses of CNTX-6016 - TEAEs
Time frame: Up to 80 days
Information regarding treatment emergent adverse events was collected during each dose cohort.
Dose Proportionality of a single doses of CNTX-6016 in healthy subjects
Time frame: 40 days
Dose Proportionality of a single doses of CNTX-6016 in healthy subjects.
CNTX-6016 Pharmacokinetics - Cmax
Time frame: Up to 40 days
Systemic exposure to CNTX-6016 measured by Cmax.
CNTX-6016 Pharmacokinetics - Tmax
Time frame: Up to 40 days
Systemic exposure to CNTX-6016 measured by Tmax.
CNTX-6016 Pharmacokinetics - t1/2
Time frame: Up to 40 days
Systemic exposure to CNTX-6016 measured by t1/2.
CNTX-6016 Pharmacokinetics - AUC 0-t
Time frame: Up to 40 days
Systemic exposure to CNTX-6016 measured by AUC 0-t.
CNTX-6016 Pharmacokinetics - AUC 0-inf
Time frame: Up to 40 days
Systemic exposure to CNTX-6016 measured by AUC 0-inf.
CNTX-6016 Pharmacokinetics - AUC 0-t/inf
Time frame: Up to 40 days
Systemic exposure to CNTX-6016 measured by AUC 0-t/inf.
CNTX-6016 Pharmacokinetics - CL/F
Time frame: Up to 40 days
Systemic exposure to CNTX-6016 measured by CL/F.
CNTX-6016 Pharmacokinetics - Vz/F
Time frame: Up to 40 days
Systemic exposure to CNTX-6016 measured by Vz/F.
Effect of Gender on CNTX-6016 Pharmacokinetics - Cmax
Time frame: Up to 80 days
Effect of Gender on the systemic exposure to CNTX-6016 measured by Cmax.
Effect of Gender on CNTX-6016 Pharmacokinetics - Tmax
Time frame: Up to 80 days
Effect of Gender on the systemic exposure to CNTX-6016 measured by tmax.
Effect of Gender on CNTX-6016 Pharmacokinetics - t1/2
Time frame: Up to 80 days
Effect of Gender on the systemic exposure to CNTX-6016 measured by t1/2
Effect of Gender on CNTX-6016 Pharmacokinetics - AUC
Time frame: Up to 80 days
Effect of Gender on the systemic exposure to CNTX-6016 measured by AUC.
Effect of Fasted or Fed State on CNTX-6016 Pharmacokinetics - Cmax
Time frame: Up to 40 days
Systemic exposure to CNTX-6016 in fasted or fed state as measured by Cmax
Effect of Fasted or Fed State on CNTX-6016 Pharmacokinetics - Tmax
Time frame: Up to 40 days
Systemic exposure to CNTX-6016 in fasted or fed state as measured by Tmax
Effect of Fasted or Fed State on CNTX-6016 Pharmacokinetics - t1/2
Time frame: Up to 40 days
Systemic exposure to CNTX-6016 in fasted or fed state as measured by t1/2
Effect of Fasted or Fed State on CNTX-6016 Pharmacokinetics - AUC
Time frame: Up to 40 days
Systemic exposure to CNTX-6016 in fasted or fed state as measured by AUC
Urinary Excretion
Time frame: Up to 6 days
Urine was collected over a 3-day period (0-72 hrs) in Cohort 8 and analyzed for concentrations of CNTX-6016 in subjects in both the fasted and fed states using Liquid Chromatography Mass Spectrometry.
1 secondary outcome
Plasma and Urine Metabolite Mining
Time frame: 5 days
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 6 Nov 2019.
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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-6016 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 5 inclusion and 12 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 6 Nov 2019. 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?
Safety of single doses of CNTX-6016 - TEAEs (time frame: Up to 80 days). The study lists 19 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 6 Nov 2019.