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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05937386 on ClinicalTrials.gov