A Phase I, Randomized, Single-dose, Crossover, 2-Period, Open-Label Study to Assess the Relative Bioavailability and Safety of Different Oral Formulations of Elecoglipron in Healthy Participants

Registration

Registration

NCT07723833

Study type

INTERVENTIONAL

Allocation

RANDOMIZED

Phase

PHASE1

Masking

NONE

Status

RECRUITING

Enrollment

152

Start

2026-07-27

Primary completion

2026-11-18

Lead sponsor

AstraZeneca

Conditions

Healthy Participants

Interventions

DRUG:Elecoglipron Reference Formulation Dose A; DRUG:Elecoglipron Test formulation 1 Dose A; DRUG:Elecoglipron Reference Formulation Dose B; DRUG:Elecoglipron Test formulation 1 Dose B; DRUG:Elecoglipron Test formulation 2 Dose A; DRUG:Elecoglipron Test formulation 2 Dose B

Results posted

FALSE

Individual participant data sharing

YES

Registered primary outcomes

• Maximum observed drug concentration (Cmax) [At pre-defined intervals from Day 1 to Day 15]
• Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast) [At pre-defined intervals from Day 1 to Day 15]
• Area under concentration-time curve from time 0 to infinity (AUCinf) [At pre-defined intervals from Day 1 to Day 15]
• Time to reach maximum observed concentration (tmax) [At pre-defined intervals from Day 1 to Day 15]
• Terminal elimination rate constant (λz) [At pre-defined intervals from Day 1 to Day 15]
• Terminal elimination half-life (t1/2λz) [At pre-defined intervals from Day 1 to Day 15]
• Apparent total body clearance (CL/F) [At pre-defined intervals from Day 1 to Day 15]
• Apparent volume of distribution based on the terminal phase (Vz/F) [At pre-defined intervals from Day 1 to Day 15]
• Ratio of elecoglipron (test formulation) to elecoglipron (reference formulation) based on AUCinf (R AUCinf) [At pre-defined intervals from Day 1 to Day 15]
• Ratio of elecoglipron (test formulation) to elecoglipron (reference formulation) based on AUClast (R AUClast) [At pre-defined intervals from Day 1 to Day 15]
• Ratio of elecoglipron (test formulation) to elecoglipron (reference formulation) based on Cmax (R Cmax) [At pre-defined intervals from Day 1 to Day 15]