Drug-Drug Interaction of Chiglitazar with Empagliflozin, Atorvastatin, and Valsartan: An Open-Label, Single-Center, Self-Control, 3-Period Study
Abstract
Background and objectives: This study aimed to characterize the drug-drug interactions (DDIs) between chiglitazar and three commonly prescribed organic anion transporting polypeptides (OATP) 1B1/1B3 substrates (empagliflozin, atorvastatin, and valsartan) in healthy Chinese participants.
Methods: In this Phase I study, healthy participants received a single oral dose of empagliflozin (10 mg), atorvastatin (20 mg), and valsartan (160 mg) on Day 1 and an oral dose of chiglitazar (48 mg) once daily from Day 5 to Day 9. On Day 10, participants received the last single dose of chiglitazar (48 mg), concurrently with a single dose of either empagliflozin (10 mg), atorvastatin (20 mg), or valsartan (160 mg). Pharmacokinetic (PK) parameters were calculated using non-compartmental analysis and the possible DDIs were statistically evaluated by mixed-effects models.
Results: Chiglitazar exposure was not significantly changed when co-administrated with empagliflozin, atorvastatin, or valsartan. As a perpetrator of DDI, co-administration of chiglitazar had a minimal effect on empagliflozin exposure, whereas it decreased valsartan area under the concentration-time curve (AUC) from time 0 to infinity (AUC0-inf) by 14.3% and maximum observed plasma concentration (Cmax) by 24.7%, respectively. Although co-administration of chiglitazar decreased atorvastatin AUC0-inf by 26.6% and Cmax by 26.9%, respectively, it had no effect on its primary metabolite, 2-hydroxy atorvastatin, with its AUC0-inf…
How strong is the evidence?
Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 10 participants or records.
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