Healthy VolunteersPhase 1NCT05937386
Drug-Drug Interaction Study With AGMB-129 and Midazolam in Healthy Participants
A Phase 1 study testing AGMB-129 and MDZ in people with Healthy Volunteers, run by Agomab Spain S.L. at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- AGMB-129 and MDZ
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteBelgium
- Study dates
- 9 Aug 2023to 6 Sep 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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
- Being tested
- AGMB-129, MDZ
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AGMB-129Drug
Oral capsule
MDZDrug
Pre-filled oral syringes
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | AGMB-129 and MDZ Receives: Drug: AGMB-129; Drug: MDZ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax for MDZ
Measured: Day 1 to Day 13
Cmax for 1-OH-midazolam
Measured: Day 1 to Day 13
AUC0-∞ for MDZ
Measured: Day 1 to Day 13
AUC0-∞ for 1-OH-midazolam
Measured: Day 1 to Day 13
Secondary outcomes (13)
Cmax for AGMB-129
Measured: Day 3 to Day 14
Cmax for MET-154
Measured: Day 3 to Day 14
Cmax for MET-158
Measured: Day 3 to Day 14
AUC0-t for AGMB-129
Measured: Day 3 to Day 14
AUC0-t for MET-154
Measured: Day 3 to Day 14
AUC0-t for MET-158
Measured: Day 3 to Day 14
AUC0-24 for AGMB-129
Measured: Day 3 to Day 14
AUC0-24 for MET-154
Measured: Day 3 to Day 14
AUC0-24 for MET-158
Measured: Day 3 to Day 14
Number of participants with adverse events
To evaluate the safety and tolerability of AGMB-129 in terms of adverse events at every visit
Measured: 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
Measured: 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
Measured: 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
Measured: From Screening to Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2023
- Study start9 Aug 2023
- Primary completion6 Sep 2023
- Study completion6 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Agomab Spain S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Philippe Wiesel, MD, Study director, Agomab Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05937386
- Sponsor's protocol ID
- AGMB-129-C104
- Status last verified
- Jun 2024
- First submitted
- 30 Jun 2023
- Last updated
- 18 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05937386
- Acronym / sponsor ID
- AGMB-129-C104
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Agomab Spain S.L.Industry (pharma, biotech, devices)
- Study start
- 9 Aug 2023 (actual)
- Primary completion
- 6 Sep 2023 (actual)
- Study completion
- 6 Sep 2023 (actual)
- First posted
- 10 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AGMB-129, Drug: MDZAGMB-129 and MDZ |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AGMB-129Oral capsule | Drug | 1 |
| MDZPre-filled oral syringes | Drug | 1 |
Primary outcome
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
13 secondary outcomes
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
Number of participants with adverse events
Time frame: From Screening to Day 15
Number of participants with abnormal clinical laboratory values
Time frame: From Screening to Day 15
Number of participants with abnormal vital signs
Time frame: From Screening to Day 15
Number of participants with abnormal physical exams
Time frame: From Screening to Day 15
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2024.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe Wiesel, MD study director
Agomab Therapeutics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AGMB-129 and MDZ in people with Healthy Volunteers, run by Agomab Spain S.L. at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax for MDZ (time frame: Day 1 to Day 13). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2024.