Overview of PK Sub-study in Phase 2 & 3 Studies
A pharmacokinetic sub-study conducted within the context of a Phase 2 or Phase 3 efficacy and safety study is an option for obtaining PK data in patients with the target disease without conducting population PK analyses. The sub-study approach seeks to obtain rich or traditional PK sampling data for noncompartmental or compartmental modeling as is seen with early phase clinical pharmacology studies (as opposed to sparse PK sampling in population PK analyses in late Phase studies).
There are many operational and scientific considerations when determining if a PK sub-study is right for a given drug development program. Nuventra’s pharmacokineticists and consultants are adept at planning not only this individual study but how this study will impact additional clinical studies and an NDA submission.
Nuventra Services Provided for these Types of Studies
- Full clinical protocol development from clinical pharmacology experts
- Clinical trial design
- Operational consultation on study set-up and execution
- PK sampling schedule evaluation
- Ensure the collection of blood and other samples occur at the right time to allow a good assessment of pharmacokinetics
- Topline PK parameter analysis (Cmax, Tmax etc.) within 24 hours
- Full PK analysis (PK parameters) conducted in WinNonlin
- Full or abbreviated PK report
- Clinical study reports (CSRs) – with integrated PK data
- Investigator Brochure (IB) updates to PK data
- FDA meetings or EMA meetings: Expert clinical pharmacology representation at regulatory meetings (including Briefing packet preparation)
- Interpretation of PK data to enable next steps in the development program
- Incorporation of data into model based drug development to allow for better decision making.
- Impact of study results on other planned clinical studies
Brief Scientific & PK Considerations for these Studies
The study design of a PK sub-study is similar to early phase clinical pharmacology studies in healthy volunteers. Subjects must be eligible for the main Phase 2 or Phase 3 study and then must meet additional requirements to participation in the PK sub-study. As with other PK investigations, the success of this type of study revolves around PK and engaging a pharmacokineticist is important during protocol development to devise a proper PK blood sampling schedule and after database lock to conduct a proper analysis of PK parameters.
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When to Execute a PK Sub-study in Development Programs
These studies are conducted during Phase 2 and Phase 3 studies in patients within the target indication.
Let Nuventra’s clinical pharmacology consultants, pharmacokineticists, and drug development experts help intelligently integrate this study into your overall development efforts. Click here for a Clinical Pharmacology Plan.
Contact us or request a quote to help with your drug development needs for this type of clinical pharmacology investigation.