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- A Phase 1 Open‐Label, Fixed‐Sequence Pharmacokinetic Drug Interaction . . .
To determine the extent of any interaction between CBD and CYP1A2 substrates, a clinical DDI trial in healthy subjects was performed The main objective was to investigate the effects of repeated doses of CBD on the PK of a single dose of caffeine
- ICH M12 Drug Interaction Final Guidance In Vitro DDI Assessments
Evaluate CYP1A2, CYP2B6, and CYP3A4 initially If the drug induces CYP3A4, evaluate the drug’s potential to induce CYP2C enzymes Down-regulation Acknowledge the phenomenon Clear recommendation
- Drug-Drug Interaction (DDI) Study in Healthy Volunteers
A Phase 1, Open Label, Fixed Sequence Study to Evaluate the Effect of BLD-0409 on the Single Dose Pharmacokinetics of a Cocktail of Probe Substrates for CYP450 Enzymes in Healthy Volunteers
- CCI - cdn. clinicaltrials. gov
The study will have 2 treatment phases, a DDI phase followed by a post-DDI phase for each study arm DDI Phase: Arm 1 Twenty patients will be enrolled into Arm 1 (CYP probe cocktail arm) Patients will receive a single oral dose of the CYP probe cocktail (losartan, dextromethorphan, caffeine, omeprazole, and midazolam) on Day -7
- Ribociclib Drug-Drug Interactions: Clinical Evaluations and . . .
Multiple 400 mg ribociclib doses increased midazolam (CYP3A substrate) AUC by 3 8-fold and caffeine (CYP1A2 substrate) AUC by 1 2-fold vs each agent alone A physiologically-based pharmacokinetic (PBPK) model was developed integrating in vitro, preclinical, and clinical data of HVs and patients with cancer
- Assays Required for Regulatory Drug-drug Interaction (DDI) Studies
DDI studies are usually conducted following guidance documents by regulatory authorities, that start with a series of in vitro evaluations, based on which in vivo DDI risk can be assessed, and follow-up clinical studies can be conducted if necessary
- CONSIDERATIONS FOR CLINICAL DRUG-DRUG INTERACTION STUDIES
Physiologically based pharmacokinetic (PBPK) modeling can give a qualitative estimation or quantitative estimation of DDI This type of pharmacokinetic modeling can predict and simulate the magnitude of interactions and evaluate the impact of intrinsic and extrinsic factors
- Drug-Drug Interaction (DDI) Studies in Phase 1: Design and Regulatory . . .
DDI studies identify whether a drug is a perpetrator (causing an interaction) or a victim (affected by another drug) This tutorial outlines the essential components of DDI study design in Phase 1, including regulatory guidance, PK PD endpoints, selection of probe substrates, and data interpretation
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