The purpose of the study is to learn how different forms of a study medication called danuglipron are taken into the blood in healthy adults, following single dose administration.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
33
Danuglipron oral tablets
Anaheim Clinical Trials, LLC
Anaheim, California, United States
Parts A, C and D only: Area under the concentration-time curve from time zero extrapolated to infinite time (AUCinf), as data permit, for danuglipron in the fasted state
Time frame: Predose to 48 hours post danuglipron administration
Parts A, C and D only: Maximum observed concentration (Cmax) for danuglipron in the fasted state
Time frame: Predose to 48 hours post danuglipron administration
Parts A, C and D only: Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast) for danuglipron (only if AUCinf is not reportable) in the fasted state
Time frame: Predose to 48 hours post danuglipron administration
Part B only: Dose normalized area under the concentration-time curve from time zero extrapolated to infinite time (AUCinf,dn), as data permit, for danuglipron in the fasted state
Time frame: Predose to 48 hours post danuglipron administration
Part B only: Dose normalized maximum observed concentration (Cmax,dn) for danuglipron in the fasted state
Time frame: Predose to 48 hours post danuglipron administration
Part B only: Dose normalized area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast,dn) for danuglipron (only if AUCinf,dn is not reportable) in the fasted state
Time frame: Predose to 48 hours post danuglipron administration
All Parts: Number of Participants reporting Treatment Emergent Adverse Events
Time frame: From baseline up to 28-35 days post last dose taken
All Parts: Number of Participants reporting Clinically Significant ECG Abnormalities
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Time frame: From baseline up to 28-35 days post last dose taken
All Parts: Number of Participants reporting Clinically Significant Vital Sign Abnormalities
Time frame: From baseline up to 28-35 days post last dose taken
All Parts: Number of participants reporting clinically significant clinical laboratory abnormalities
Time frame: From baseline up to 28-35 days post last dose taken
All Parts: Area under the concentration-time curve from time zero extrapolated to infinite time (AUCinf), as data permit, for danuglipron in the fed state
Time frame: Predose to 48 hours post danuglipron administration
All Parts: Maximum observed concentration (Cmax) for danuglipron in the fed state
Time frame: Predose to 48 hours post danuglipron administration
All Parts: Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast) for danuglipron (only if AUCinf is not reportable) in the fed state
Time frame: Predose to 48 hours post danuglipron administration