First‐in‐human study of CPL207280 , a novel G‐protein‐coupled receptor 40/free fatty acid receptor 1 agonist, in healthy volunteers after single and multiple administration
Authors' conclusion
CPL207280 was found to be safe and well tolerated by healthy volunteers (with a low risk of hepatotoxicity) for up to 14 days of administration. The PK profile of CPL207280 supports single-daily administration and justifies further development of this therapy for patients with T2D.
Study context
- Population
- Healthy volunteers (White, age 18–55 years, BMI 18.5–29.9 kg/m²)
- Participants
- 24 / 32 / 12
- Exposure
- Single and multiple once-daily doses of CPL207280
- Single dosen = 24
- Multiple dosen = 32
- Food/metforminn = 12
- Outcome
- Safety and tolerability of CPL207280
Methodological detailssingle and multiple ascending doses, food effect and metformin interaction cohort
- Single and multiple ascending doses
- Food effect and metformin interaction cohort
Main finding
As reported in the abstract
Deaths or serious adverse events (AEs)
0
Observational data: associations, not effects.
Secondary outcomes
Pharmacokinetic (PK)
- Ascending dose increased Cmax or AUC up to 24 h
- Dose-normalized Cmax decreased with ascending dose
- No relationship between dose or prandial state and terminal elimination half-life and rate constant
PD (glucose, insulin, C-peptide, proinsulin, glucagon) · 14-day treatment period
- No clear relationship between dose and PD area under the effect curve values
Deaths and serious AEs
- No deaths or serious AEs reported
Original publication
First‐in‐human study of CPL207280 , a novel G‐protein‐coupled receptor 40/free fatty acid receptor 1 agonist, in healthy volunteers after single and multiple administration. Diabetes Obes Metab. Published 11 January 2024. doi:10.
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