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

NCT05937386 | Completed Phase 1

• 1 other identifier: AGMB-129-C104
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (4)

• Cmax for MDZ

  Day 1 to Day 13

• Cmax for 1-OH-midazolam

  Day 1 to Day 13

• AUC0-∞ for MDZ

  Day 1 to Day 13

• AUC0-∞ for 1-OH-midazolam

  Day 1 to Day 13

Secondary Outcomes (13)

• Cmax for AGMB-129

  Day 3 to Day 14

• Cmax for MET-154

  Day 3 to Day 14

• Cmax for MET-158

  Day 3 to Day 14

• AUC0-t for AGMB-129

  Day 3 to Day 14

• AUC0-t for MET-154

  Day 3 to Day 14

Study Arms (1)

1

EXPERIMENTAL

AGMB-129 and MDZ

Drug: AGMB-129; Drug: MDZ

Interventions

AGMB-129 DRUG

Oral capsule

1

MDZ DRUG

Pre-filled oral syringes

1

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female, between 18 and 55 years old (extremes included) on the date of signing the ICF.
• Body weight of at least 50.0 kg for men and 45.0 kg for women, and a body mass index (BMI) between 19.0 and 30.0 kg/m2 (extremes included) at screening.
• Must be in good health based on medical history, physical examination, vital signs, and 12-lead ECG in the opinion of the investigator at screening.
• Total bilirubin, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) must be ≤1.5x upper limit of normal (ULN) at screening. Other clinical laboratory safety test results must be within the reference ranges or test results that are outside the reference ranges need to be considered not clinically significant in the opinion of the investigator. Note: Participants with diagnosed Gilbert's syndrome with total bilirubin \>1.5 ULN are eligible for the study if AST and ALT are ≤1.5x ULN.

You may not qualify if:

• Known hypersensitivity to AGMB-129 ingredients or history of a significant allergic reaction to AGMB-129 ingredients as determined by the investigator.
• Positive serology for hepatitis B virus surface antigen (HBsAg) or anti-hepatitis C virus \[HCV\] antibodies at screening, or history of hepatitis from any cause except for hepatitis A that was resolved at least 3 months prior to the first IP administration.
• History of or a current immunosuppressive condition, including positive human immunodeficiency virus types 1 or 2 (HIV-1 \[2\]) antibodies at screening.
• Current or history of vasculitis, valvular heart disease, or large vessel vascular disease (such as aneurism or dissection) at screening.
• Any illness, judged by the investigator as clinically significant, in the 3 months prior to the first IP administration.
• Presence or sequelae of gastrointestinal, liver, kidney (estimated glomerular filtration rate \[eGFR\] ≤80 mL/min/1.73 m² using the Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] formula) or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs at screening.
• History of malignancy within the past 5 years prior to screening, except for excised and curatively treated non-metastatic basal cell carcinoma, squamous cell carcinoma of the skin, or carcinoma in situ of cervix which is considered cured with minimal risk of recurrence.
• History or presence of clinically significant abnormalities detected on 12-lead ECG of either rhythm or conduction, e.g., known long QT syndrome or a QT interval corrected for heart rate according to Fridericia's formula (QTcF) \>450 ms detected on the 12-lead ECG at screening or Day 1 predose. A first-degree atrioventricular block will not be considered as a clinically significant abnormality.

Sponsors & Collaborators

• Agomab Spain S.L.: lead

Study Sites (1)

SGS Belgium

Edegem, Belgium

Location

Study Officials

• Philippe Wiesel, MD

  Agomab Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2023
• First Posted: July 10, 2023
• Study Start: August 9, 2023
• Primary Completion: September 6, 2023
• Study Completion: September 6, 2023
• Last Updated: June 18, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)