Safety, Tolerability, and Pharmacokinetics of a Novel Mitochondrial Modulator, TRC150094, in Overweight and Obese Subjects: A Randomized Phase-I Clinical Trial.

ABSTRACT: TRC150094, a novel mitochondrial modulator, can restore metabolic flexibility by improving insulin resistance in preclinical studies. This study primarily aims to evaluate the safety, tolerability, and pharmacokinetics (PK) of oral TRC150094 after conducting two double-blind, randomized, Phase-I studies, single ascending dose (SAD) and multiple ascending dose (MAD), with n = 46, in overweight/obese adult and elderly subjects. In addition, the effect of TRC150094 on pharmacodynamic (PD) efficacy markers was evaluated. PK assessments, including maximum concentration (C_max), area under the plasma concentration (AUC), time to C_max (T_max), and elimination half-life (t½), were assessed at pre-specified time points. PD assessments included apolipoprotein B

SUBMITTER: Joshi D 

PROVIDER: S-EPMC8485898 | biostudies-literature | 2021

REPOSITORIES: biostudies-literature