NCT05937386

Drug-Drug Interaction Study With AGMB-129 and Midazolam in Healthy Participants

An Open-Label, Fixed-Sequence, Drug-Drug Interaction Study in Healthy Participants to Evaluate the Effect of AGMB-129 on the Pharmacokinetics of Midazolam, a Sensitive Index Substrate of CYP3A4

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Agomab Spain S.L. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	AGMB-129	Oral capsule
DRUG	MDZ	Pre-filled oral syringes

Timeline

• Start date: 2023-08-09
• Primary completion: 2023-09-06
• Completion: 2023-09-06
• First posted: 2023-07-10
• Last updated: 2024-06-18

Locations

1 site across 1 country: Belgium