This study describes the clinical, hematological, and
biochemical safety of tetradecylthioacetic acid (TTA). A total of 18
healthy volunteers were included. Subjects were randomly assigned
into 3 groups according to the daily given dose of TTA: group 1 (200
mg), group 2 (600 mg), and group 3 (1000 mg). TTA was given as
a single oral dose for 7 consecutive days. Safety was evaluated by
following the adverse events, vital signs, and hematological and
biochemical parameters in blood and urine samples. Efficacy was
estimated through its effects on plasma lipids profile. Few adverse
events of mild severity were reported. No clinically significant
changes were observed in the hematological or clinical chemical
parameters in blood/urine. TTA did not induce significant changes in
the blood lipids or free fatty acids, but it did result in an increase in
plasma concentration of D9 desaturated TTA (TTA: 1n-8). Serum
concentration pattern of TTA at day 1 showed a 1.5-hour lag time
followed by a rapid absorption and a slower elimination phase. The
median peak values were 2.9 mg/L (range, 1.1 to 5.4 mg/L), 11.5
mg/L (range, 4 to 35 mg/L), and 11 mg/L (range, 5 to 25 mg/L), in
groups 1, 2, and 3, respectively (P = 0.006). The time to peak levels
were 3.5 hours (range, 2.5 to 6.5 hours), 2.5 hours (range, 2.5 to 4.5
hours), and 4.5 hours (range, 2.5 to 12 hours), respectively (P = 0.2).
TTA is safe and well tolerated. |
