This study is designed to assess the safety and tolerability, pharmacokinetics, and pharmacodynamics of CT-996 in overweight/obese participants and participants with Type 2 Diabetes Mellitus (T2DM).
This is a multi-center, randomized, double-blind, placebo-controlled, dose escalation, first in human study designed to assess the safety and tolerability, pharmacokinetics, and pharmacodynamics of CT-996 when administered as single ascending doses (SAD) and multiple-ascending doses (MAD) in overweight/obese participants and as multiple doses (MD) in patients with T2DM.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
94
Nucleus Network Pty Ltd.
Melbourne, Australia
Avant Santé Research Center S.A. de C.V.
San Pedro Garza García, Mexico
Incidence of Treatment-Emergent Adverse Events
Time frame: From first study drug administration until last safety follow-up (up to 31 days [Part 1] or 58 days [Parts 2 and 3])
Maximum Observed Plasma Concentration (Cmax) of CT-996
Time frame: At prespecified timepoints from Day 1 to Day 5 (Part 1) or Day 33 (Parts 2 and 3)
Time to Maximum Observed Plasma Concentration (Tmax) of CT-996
Time frame: At prespecified timepoints from Day 1 to Day 5 (Part 1) or Day 33 (Parts 2 and 3)
Area Under the Concentration-Time Curve (AUC) from Time 0 to the Time of Last Measurable Concentration (AUC0-t) of CT-996
Time frame: At prespecified timepoints from Day 1 to Day 5 (Part 1) or Day 33 (Parts 2 and 3)
AUC from Time 0 Extrapolated to Infinity (AUC0-inf) of CT-996
Time frame: At prespecified timepoints from Day 1 to Day 5 (Part 1) or Day 33 (Parts 2 and 3)
Apparent Terminal Elimination Half-Life (t1/2) of CT-996
Time frame: At prespecified timepoints from Day 1 to Day 5 (Part 1) or Day 33 (Parts 2 and 3)
Part 1 Cohorts: Clearance (CL) of CT-996
Time frame: At prespecified timepoints from Day 1 to Day 5
Part 1 Cohorts: Volume of Distribution (V) of CT-996
Time frame: At prespecified timepoints from Day 1 to Day 5
Part 2 Cohorts: Minimum Observed Plasma Concentration (Cmin) of CT-996
Time frame: At prespecified timepoints from Day 1 to Day 33
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Parts 2 and 3 Cohorts: Clearance Divided by the Bioavailable Fraction (CL/F) of CT-996
Time frame: At prespecified timepoints from Day 1 to Day 33
Parts 2 and 3 Cohorts: Volume of Distribution Divided by the Bioavailable Fraction (Vz/F) of CT-996
Time frame: At prespecified timepoints from Day 1 to Day 33
Part 1 SAD Cohorts 3 and 5: Food Effect of a High-Fat Meal on Cmax of CT-996
Determine the effect of a high-fat meal on the PK of CT-996 following a single dose
Time frame: At prespecified timepoints for up to 14 days
Part 1 SAD Cohorts 3 and 5: Food Effect of a High-Fat Meal on AUC of CT-996
Determine the effect of a high-fat meal on the PK of CT-996 following a single dose
Time frame: At prespecified timepoints for up to 14 days