Altasciences Clinical Research
Overland Park, Kansas, 66212, United States
NCT Number: NCT04154501
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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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Overland Park, Kansas, 66212, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria:
Oral Dose CNTX-6016
Oral Dose Placebo
Time frame: Up to 80 days
Information regarding treatment emergent adverse events was collected during each dose cohort.
Time frame: 40 days
Dose Proportionality of a single doses of CNTX-6016 in healthy subjects.
Time frame: Up to 40 days
Systemic exposure to CNTX-6016 measured by Cmax.
Time frame: Up to 40 days
Systemic exposure to CNTX-6016 measured by Tmax.
Time frame: Up to 40 days
Systemic exposure to CNTX-6016 measured by t1/2.
Time frame: Up to 40 days
Systemic exposure to CNTX-6016 measured by AUC 0-t.
Time frame: Up to 40 days
Systemic exposure to CNTX-6016 measured by AUC 0-inf.
Time frame: Up to 40 days
Systemic exposure to CNTX-6016 measured by AUC 0-t/inf.
Time frame: Up to 40 days
Systemic exposure to CNTX-6016 measured by CL/F.
Time frame: Up to 40 days
Systemic exposure to CNTX-6016 measured by Vz/F.
Time frame: Up to 80 days
Effect of Gender on the systemic exposure to CNTX-6016 measured by Cmax.
Time frame: Up to 80 days
Effect of Gender on the systemic exposure to CNTX-6016 measured by tmax.
Time frame: Up to 80 days
Effect of Gender on the systemic exposure to CNTX-6016 measured by t1/2
Time frame: Up to 80 days
Effect of Gender on the systemic exposure to CNTX-6016 measured by AUC.
Time frame: Up to 40 days
Systemic exposure to CNTX-6016 in fasted or fed state as measured by Cmax
Time frame: Up to 40 days
Systemic exposure to CNTX-6016 in fasted or fed state as measured by Tmax
Time frame: Up to 40 days
Systemic exposure to CNTX-6016 in fasted or fed state as measured by t1/2
Time frame: Up to 40 days
Systemic exposure to CNTX-6016 in fasted or fed state as measured by AUC
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.
Time frame: 5 days
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.
Centrexion Therapeutics
Industry
A Study to Evaluate the Safety and Pharmacokinetics of Single Doses of CNTX-6016 in Healthy Subjects
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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