Drug-Drug Interaction Study With AGMB-129 and Midazolam in Healthy Participants
NCT05937386 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14
Last updated 2024-06-18
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
- DRUG
-
AGMB-129
Oral capsule
- DRUG
-
MDZ
Pre-filled oral syringes
Sponsors & Collaborators
-
Agomab Spain S.L.
lead INDUSTRY
Principal Investigators
-
Philippe Wiesel, MD · Agomab Therapeutics
Study Design
- Allocation
- NA
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-08-09
- Primary Completion
- 2023-09-06
- Completion
- 2023-09-06
Countries
- Belgium
Study Locations
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