A Phase 1, Single-Center, Repeat-Dose, Open-Label, Fixed-Sequence Drug-Drug Interaction Study of ZX008 in Healthy Male Or Female Study Participants 18 To 55 Years Of Age
Abstract
The purpose of the study is to assess the single-dose pharmacokinetics (PK) of 3 probe drugs (midazolam, bupropion, and metformin) before and after repeat doses of ZX008
Conditions: Healthy Study Participants.
Primary outcome: Maximum Concentration (Cmax) of Midazolam Alone and in Combination With ZX008 at Steady State; Maximum Concentration (Cmax) of Metformin Alone and in Combination With ZX008 at Steady State; Maximum Concentration (Cmax) of Bupropion Alone and in Combination With ZX008 at Steady State; Area Under the Curve From 0 to Infinity (AUC) of Midazolam Alone and in Combination With ZX008 at Steady State; Area Under the Curve From 0 to Infinity (AUC) of Metformin Alone and in Combination With ZX008 at Steady State; Area Under the Curve From 0 to Infinity (AUC) of Bupropion Alone and in Combination With ZX008 at Steady State; Area Under the Curve From 0 to the Time of the Last Quantifiable Concentration AUC(0-t) of Midazolam Alone and in Combination With ZX008 at Steady State; Area Under the Curve From 0 to the Time of the Last Quantifiable Concentration AUC(0-t) of Metformin Alone and in Combination With ZX008 at Steady State; Area Under the Curve From 0 to the Time of the Last Quantifiable Concentration AUC(0-t) of Bupropion Alone and in Combination With ZX008 at Steady State.
Enrollment: 22 participants.
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: 22 participants or records.
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