Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PAL-119 in Healthy Volunteers and Adult Participants With Type 1 or Type 2 Diabetes

Phase 1 Parts 1, 2 and 3

Healthy volunteers age 18 to 55 years of age

Medically healthy with no clinically significant findings

BMI 18-35 kg/m²

eGFR ≥90

Able and willing to provide written informed consent

Able to swallow an oral solid-dosage form of medication.

Willing and able to follow a low-tyramine diet and abstain from prohibited medications from 48 hours prior to first dose and for the duration of the study and for 14 days after the last dose

Contraception use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies

ability to consume high-fat meal (Part 3 only)

Phase 2 Part 4:

18 to ≤70 years of age

Confirmed Type 2 diabetes diagnosis ≥6 months and ≤15 years prior to screening

BMI 25 to 40 kg/m² at Screening

Able and willing to provide written informed consent

Stable diabetes therapy for ≥12 weeks prior to screening visit

Willing and able to follow a low-tyramine diet and abstain from prohibited medications for the duration of the study and for 14 days after the last dose

Contraception use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies

Phase 2 Part 5

18 to ≤70 years of age

Confirmed Type 1 diabetes diagnosis ≥6 months and ≤10 years prior to screening visit

Stable insulin regimen for ≥12 weeks prior to screening visit

Willingness to use continuous glucose monitoring (CGM) for continuous periods during the study

Able and willing to provide written informed consent

Contraception use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies

Willing and able to follow a low-tyramine diet and abstain from prohibited medications for the duration of the study and for 14 days after the last dose

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PAL-119 in Healthy Volunteers and Adult Participants With Type 1 or Type 2 Diabetes

What this study is about

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PAL-119 in Healthy Volunteers and Adult Participants With Type 1 or Type 2 Diabetes

What this study is about