This is a randomized, open-label, two-period, crossover Phase 1 to assess the impact of CIN-107 on the pharmacokinetics (PK) of metformin and the safety and tolerability of coadministration of CIN-107 and metformin as compared to metformin alone.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
27
Medpace Clinical Pharmacology Unit
Cincinnati, Ohio, United States
Maximum plasma concentration (Cmax)
This plasma PK parameter will be determined for CIN-107, its primary metabolite (CIN-107-M), and any other measured metabolites.
Time frame: Up to day 3
Time to Cmax (Tmax)
This plasma PK parameter will be determined for CIN-107, its primary metabolite (CIN-107-M), and any other measured metabolites.
Time frame: Up to day 3
Area under the concentration-time curve (AUC) from time 0 to 72 hours
This plasma PK parameter will be determined for CIN-107, its primary metabolite (CIN-107-M), and any other measured metabolites.
Time frame: Up to day 3
Maximum plasma concentration (Cmax) of metformin
This plasma PK parameter will be determined for metformin.
Time frame: Up to day 3
Time to Cmax (Tmax) of metformin
This plasma PK parameter will be determined for metformin.
Time frame: Up to day 3
AUC from time 0 to the time of last quantifiable plasma concentration of metformin
This plasma PK parameter will be determined for metformin.
Time frame: Up to day 3
AUC from time 0 to infinity of metformin
This plasma PK parameter will be determined for metformin.
Time frame: Up to day 3
Percent of AUC extrapolated of metformin
This plasma PK parameter will be determined for metformin.
Time frame: Up to day 3
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Terminal phase elimination half-life of metformin
This plasma PK parameter will be determined for metformin.
Time frame: Up to day 3
Cumulative amount of metformin excreted in the urine (Ae) of metformin
This urine PK parameter will be determined for metformin.
Time frame: Up to day 3
Renal clearance (calculated as Ae/AUC) of metformin
This urine PK parameter will be determined for metformin.
Time frame: Up to day 3
Fraction of the dose excreted renally of metformin
This urine PK parameter will be determined for metformin.
Time frame: Up to day 3