Pharmacokinetic Study of Terpinolene in Healthy Subjects (PKT Study)

Launched by SINGAPORE INSTITUTE OF FOOD AND BIOTECHNOLOGY INNOVATION · Nov 13, 2024

Keywords

ClinConnect Summary

Traditionally, the toxicological hazards of chemical substances have been identified and evaluated using animal studies. With the global shift towards limiting the use of animals in human safety assessment, "Next Generation Risk Assessment (NGRA)" has been conceptualized as a human-relevant, exposure-led approach integrating in silico, in chemico and in vitro methodologies. Consequently, in silico physiologically based pharmacokinetic (PBPK) modelling strategies have emerged as a central component of the NGRA paradigm. By mapping compound behaviour (i.e. absorption, distribution, metabolism...

Gender

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Eligibility criteria

• Inclusion Criteria:
• • Aged 21-50
• • Chinese, Malay and Indian ethnicities
• • Male or female
• • Adequate fluency in the English language to understand the informed consent process, study instructions and study assessments
• • Sufficient vision and hearing to complete the study procedures
• • Willing and able to participate and to give written informed consent
• Exclusion Criteria:
• • Past (\<3 months prior to the study) or current major metabolic, endocrine, gastrointestinal or cardiovascular disease
• • Individuals diagnosed with non-alcoholic fatty liver disease
• • Major surgery in the past 2 months
• • On chronic medication
• • Allergy to olive oil
• • Vegetarian/vegan
• • Smoking
• • Pregnant or lactating
• • Alcohol intake \>1 units per day
• • Body Mass Index \<18.5 kg/m2 or ≥27 kg/m2
• • Body weight \<54 kg
• • Member of the study team or their immediate family members