This is a single-center, open-label, fixed-sequence, Phase 1 study in healthy adult participants to evaluate the effect of AGMB-129 on the PK of a single dose of MDZ in healthy participants. A total of 14 participants will be enrolled and will receive study intervention in a fixed-sequence scheme. All IP will be administered orally and in fed conditions. The total duration of involvement for each participant, screening through follow-up, will be approximately 6 weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
14
SGS Belgium
Edegem, Belgium
Cmax for MDZ
Time frame: Day 1 to Day 13
Cmax for 1-OH-midazolam
Time frame: Day 1 to Day 13
AUC0-∞ for MDZ
Time frame: Day 1 to Day 13
AUC0-∞ for 1-OH-midazolam
Time frame: Day 1 to Day 13
Cmax for AGMB-129
Time frame: Day 3 to Day 14
Cmax for MET-154
Time frame: Day 3 to Day 14
Cmax for MET-158
Time frame: Day 3 to Day 14
AUC0-t for AGMB-129
Time frame: Day 3 to Day 14
AUC0-t for MET-154
Time frame: Day 3 to Day 14
AUC0-t for MET-158
Time frame: Day 3 to Day 14
AUC0-24 for AGMB-129
Time frame: Day 3 to Day 14
AUC0-24 for MET-154
Time frame: Day 3 to Day 14
AUC0-24 for MET-158
Time frame: Day 3 to Day 14
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Number of participants with adverse events
To evaluate the safety and tolerability of AGMB-129 in terms of adverse events at every visit
Time frame: From Screening to Day 15
Number of participants with abnormal clinical laboratory values
To evaluate the safety and tolerability of AGMB-129 in terms of abnormal laboratory parameters at every visit
Time frame: From Screening to Day 15
Number of participants with abnormal vital signs
To evaluate the safety and tolerability of AGMB-129 in terms of vital signs at every visit
Time frame: From Screening to Day 15
Number of participants with abnormal physical exams
To evaluate the safety and tolerability of AGMB-129 in terms of physical exams at every visit
Time frame: From Screening to Day 15