Type 2 Diabetes Mellitus (T2DM) Clinical Trial
Official title:
A Single-Center, Randomized, Open-Label, 2-Period Complete Crossover Study to Compare the Bioavailability of a Capsule Formulation of LGD-6972 to an Oral Solution Formulation in Healthy Adult Subjects
The purpose of this study is to compare relative oral bioavailability of a capsule formulation of LGD-6972 to a solution formulation of LGD-6972.
This is a single center, randomized, open-label, single dose study conducted in a 2-way
crossover design.
A total of 8 subjects will be enrolled in the study. The duration of participation for each
subject will be approximately 36 days, not including a Screening Period of up to 30 days.
Each treatment period, subjects will be admitted to the study site on Day -1 and observed
through the morning of Day 3 (48-hour post-dose assessment). Over 2 treatment periods,
subjects will receive each of the following treatments as a single dose orally, under
fasting conditions, per the randomization (4 subjects per treatment in each treatment
period:
Treatment A - 15 mg of LGD-6972 as capsules
Treatment B - 15 mg LGD-6972 as solution
Serial blood samples will be collected through 48 hours following each dose to determine the
concentration of LGD 6972 in plasma. Safety assessments will also occur during this time.
Subjects will be discharged from the study site after the 48 hour assessments and return to
the study site on Days 4, 7, and 14 for follow up procedures. Subjects will return to the
study site for the second treatment period after an additional 7 days. Subjects will be
discharged from the study after returning to the study site on Day 14 of the second
treatment period.
;
Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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