Advance your Human ADME (hAME) Studies development with confidence
Fortrea Clinical Pharmacology Services are designed to support the increasing complexity of drug and device development, helping sponsors generate the data needed to progress with clarity and control.
From first-in-human studies through early patient trials, our integrated approach brings together clinical expertise, dedicated facilities, and operational alignment to support efficient study delivery.
With over 500 hAME trials , Fortrea offers a one stop solution for all services in support of the conduct of the trials.
We also have dedicated staff to support these studies such as Nuclear Pharmacists, a Radiation Safety Officer and a Radiation Safety Committee in Madison and Radiation Protection Supervisors, and a Radiation Management Committee in Leeds.
Supporting radiolabelled human ADME (hAME) studies globally
Radiolabelled human absorption, distribution, metabolism, and excretion (hAME) studies play an important role in understanding drug pharmacokinetics and metabolic pathways.
At Fortrea, we have conducted over 500 radiolabelled hAME studies, supporting pharmaceutical companies with data required for regulatory submissions and development decisions.
Specialized infrastructure and geographic flexibility
Madison, USA: A well-established campus supporting a high volume of radiolabelled hAME studies, including both macrotracer and microtracer designs
Leeds, UK: A purpose-built Phase I unit optimized for hAME study conduct, extending capability into Europe
With facilities in both regions, Fortrea can support radiolabeled hAME studies across multiple locations, helping address logistical considerations associated with radiolabelled investigational product handling.
Our capabilities
We offer a comprehensive suite of clinical pharmacology services to support early-phase development:
- First-in-human (FIH), single and multiple ascending dose studies
- Pharmacokinetics (PK) and pharmacodynamics (PD) assessments
- Drug-drug interaction (DDI) studies
- Food effect (FE) studies
- Thorough QT (TQT) assessments
- Bioavailability (BA) and bioequivalence (BE) studies
- Exploratory biomarker and translational studies
Our external site network extends these capabilities to specialized populations, including renal and hepatic impairment and diverse patient groups.
Dedicated infrastructure and global reach
Fortrea operates dedicated Phase I clinical research units (CRUs) across the United States and the UK, designed to support a wide range of early-phase studies. Purpose-built facilities with on-site pharmacy and with easier access to the bioanalytical laboratories capabilities
- Flexible capacity to support diverse study designs
- Global network of investigator sites to expand into patient populations
This combination enables continuity from healthy volunteer studies through early patient research.
An approach designed for today’s development challenges
Clinical pharmacology studies are increasingly interconnected, often requiring coordination across multiple study types and timelines.
Fortrea’s model supports this complexity by aligning scientific, operational, and data considerations from the outset—helping sponsors move from preclinical insights to early clinical signals with a structured approach.
Supporting your development journey
Whether you are generating first-in-human data or planning broader early-phase programs, Fortrea Clinical Pharmacology Services provide the foundation to support informed decision-making in early development.
Frequently Asked Questions
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What are the key considerations for radiolabelled Human ADME (hAME) studies?
Successful hAME studies require careful planning around radiolabelling strategy and timing, regulatory requirements, clinical execution, and bioanalytical assessments to generate meaningful metabolism and excretion data.
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When should Human ADME (hAME) studies be conducted during drug development?
hAME studies are typically conducted during early clinical development to understand human metabolism, support regulatory planning, and inform subsequent clinical pharmacology studies with the goal of having some metabolite data by the end of Phase 2.
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What data do Human ADME (hAME) studies provide?
Information on drug absorption, metabolism, routes of elimination, mass balance, metabolite profiles, and overall pharmacokinetic behavior can help interpret or assess whether a drug has desirable ADME properties, relevancy of tox species, cause of toxicities observed in animal studies, proper drug dose to administer to animals and humans, potential adverse drug interactions in humans, human variability impact on drug disposition, and the need for hepatic or renal impairment studies.
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How can Fortrea support Human ADME (hAME) studies?
With our extensive experience, Fortrea specialists can help develop your study design, perform clinical conduct, assist with radiosynthesis of your drug molecule, manufacture radiolabeled dose formulations and have them tested, contract analytical labs for bioanalysis and metabolite profiling and identification, perform PK data analysis, and provide you with regulatory-ready reporting through our integrated approach
Insights