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A Phase 1 double-blind, placebo-controlled, randomized single ascending dose incorporating an open-label, 2-period crossover, food effect cohort.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 Placebo | Placebo Comparator | Oral Placebo Capsule |
|
| Cohort 1 Drug | Experimental | 25 mg Oral Capsule |
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| Cohort 2 Placebo | Placebo Comparator | Oral Placebo Capsule |
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| Cohort 2 Drug | Experimental | 50 mg Oral Capsule |
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| Cohort 3 Placebo | Placebo Comparator | Oral Placebo Capsule |
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| Cohort 3 Drug | Experimental | 100 mg Oral Capsule |
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| Cohort 4 Placebo |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CNTX-6016 | Drug | Oral Dose CNTX-6016 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety of single doses of CNTX-6016 - TEAEs | Information regarding treatment emergent adverse events was collected during each dose cohort. | 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. | 40 days |
| CNTX-6016 Pharmacokinetics - Cmax | Systemic exposure to CNTX-6016 measured by Cmax. | Up to 40 days |
| CNTX-6016 Pharmacokinetics - Tmax | Systemic exposure to CNTX-6016 measured by Tmax. | Up to 40 days |
| CNTX-6016 Pharmacokinetics - t1/2 | Systemic exposure to CNTX-6016 measured by t1/2. | Up to 40 days |
| CNTX-6016 Pharmacokinetics - AUC 0-t | Systemic exposure to CNTX-6016 measured by AUC 0-t. | Up to 40 days |
| CNTX-6016 Pharmacokinetics - AUC 0-inf | Systemic exposure to CNTX-6016 measured by AUC 0-inf. | Up to 40 days |
| CNTX-6016 Pharmacokinetics - AUC 0-t/inf | Systemic exposure to CNTX-6016 measured by AUC 0-t/inf. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 5 days |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Randall M Stevens, MD | Centrexion Therapeutics | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Altasciences Clinical Research | Overland Park | Kansas | 66212 | United States |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D059226 | Nociceptive Pain |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Placebo Comparator |
Oral Placebo Capsule |
|
| Cohort 4 Drug | Experimental | 300 mg Oral Capsule |
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| Cohort 5 Placebo | Placebo Comparator | Oral Placebo Capsule |
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| Cohort 5 Drug | Experimental | 450 mg Oral Capsule |
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| Cohort 6 Placebo | Placebo Comparator | Oral Placebo Capsule |
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| Cohort 6 Drug | Experimental | 600 mg Oral Capsule |
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| Cohort 7 Placebo | Placebo Comparator | Oral Placebo Capsule |
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| Cohort 7 Drug | Experimental | 800 mg Oral Capsule |
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| Cohort 9 Placebo | Placebo Comparator | Oral Placebo Capsule |
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| Cohort 9 Drug | Experimental | 1000 mg Oral Capsule |
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| Cohort 8 Fasted | Experimental | Participant will take 300 mg Oral Capsule in a fasting state, and then fed state. |
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| Cohort 8 Fed | Experimental | Participant will take 300 mg Oral Capsule in a fed state, and then fasting state. |
|
| Other: Placebo | Other | Oral Dose Placebo |
|
| Up to 40 days |
| CNTX-6016 Pharmacokinetics - CL/F | Systemic exposure to CNTX-6016 measured by CL/F. | Up to 40 days |
| CNTX-6016 Pharmacokinetics - Vz/F | Systemic exposure to CNTX-6016 measured by Vz/F. | 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. | 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. | 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 | 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. | 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 | 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 | 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 | 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 | 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. | Up to 6 days |