A Phase 1 double-blind, placebo-controlled, randomized single ascending dose incorporating an open-label, 2-period crossover, food effect cohort.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
68
Oral Dose CNTX-6016
Oral Dose Placebo
Altasciences Clinical Research
Overland Park, Kansas, United States
Safety of single doses of CNTX-6016 - TEAEs
Information regarding treatment emergent adverse events was collected during each dose cohort.
Time frame: 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.
Time frame: 40 days
CNTX-6016 Pharmacokinetics - Cmax
Systemic exposure to CNTX-6016 measured by Cmax.
Time frame: Up to 40 days
CNTX-6016 Pharmacokinetics - Tmax
Systemic exposure to CNTX-6016 measured by Tmax.
Time frame: Up to 40 days
CNTX-6016 Pharmacokinetics - t1/2
Systemic exposure to CNTX-6016 measured by t1/2.
Time frame: Up to 40 days
CNTX-6016 Pharmacokinetics - AUC 0-t
Systemic exposure to CNTX-6016 measured by AUC 0-t.
Time frame: Up to 40 days
CNTX-6016 Pharmacokinetics - AUC 0-inf
Systemic exposure to CNTX-6016 measured by AUC 0-inf.
Time frame: Up to 40 days
CNTX-6016 Pharmacokinetics - AUC 0-t/inf
Systemic exposure to CNTX-6016 measured by AUC 0-t/inf.
Time frame: Up to 40 days
CNTX-6016 Pharmacokinetics - CL/F
Systemic exposure to CNTX-6016 measured by CL/F.
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Time frame: Up to 40 days
CNTX-6016 Pharmacokinetics - Vz/F
Systemic exposure to CNTX-6016 measured by Vz/F.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: Up to 6 days
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.
Time frame: 5 days