BridgeMD
An open-label, non-randomised safety and tolerability Proof of Concept Trial to examine multiple dosing addition of glycocholate (GC) and butyrate (B) to increase Ca absorption in healthy female participants that have undergone Roux-en-Y gastric bypass (BAFA)
EU CTIS ID: 2024-511124-14-00
What this study is testing
The primary objective of this trial is to assess the safety and tolerability of GC and B following administration of multiple dosing.
- Phase I and Phase II (Integrated)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Provision of signed and dated, written informed consent prior to any study specific procedures.
- Healthy female and male subjects ≥20 years of age ≤65 years of age.
- Healthy operated patients with RYGB >12 months ago on daily micronutrient substitution free from medicines (medicines for steady state medical conditions allowed) with normal blood calcium, vitamin D and calcium supplementation and ability to take BAFA
- Have a steady weight phase (weight within 5 kg variation within last 3 months) and a body mass index from ≥ 20 to ≤ 45 kg/m2
- Females must have a negative pregnancy test and use anticonceptives.
- Subjects must be able to understand and willing to comply with study procedures, restrictions and requirements as judged by the investigator.
You likely can't join if
- Women with a positive pregnancy test on enrolment or lactating women.
- History of hypersensitivity and allergy, as judged by the investigator
- Subjects not tolerating injections.
- Complicated RYGB (for example failed primary operation or severe postop complications that affect GI function)), other previous surgeries in the abdomen (appendectomy/cholecystectomy allowed) or severe abdominal complaints.
- Subjects not tolerating taste of IMP
- Have previous (<12 months) treatments that may have had impact on bone metabolism.
See the full eligibility criteria
Who can join
- Provision of signed and dated, written informed consent prior to any study specific procedures.
- Healthy female and male subjects ≥20 years of age ≤65 years of age.
- Healthy operated patients with RYGB >12 months ago on daily micronutrient substitution free from medicines (medicines for steady state medical conditions allowed) with normal blood calcium, vitamin D and calcium supplementation and ability to take BAFA
- Have a steady weight phase (weight within 5 kg variation within last 3 months) and a body mass index from ≥ 20 to ≤ 45 kg/m2
- Females must have a negative pregnancy test and use anticonceptives.
- Subjects must be able to understand and willing to comply with study procedures, restrictions and requirements as judged by the investigator.
What rules you out
- Women with a positive pregnancy test on enrolment or lactating women.
- History of hypersensitivity and allergy, as judged by the investigator
- Subjects not tolerating injections.
- Complicated RYGB (for example failed primary operation or severe postop complications that affect GI function)), other previous surgeries in the abdomen (appendectomy/cholecystectomy allowed) or severe abdominal complaints.
- Subjects not tolerating taste of IMP
- Have previous (<12 months) treatments that may have had impact on bone metabolism.
- Have other conditions that make principal investigator insecure on study participation.
- Involvement in the planning, and/or conduct of the study
- Previous enrolment or randomization in the present study
- Participation in another clinical study with an IMP during the last 3 months prior to enrolment.
- History of any unstable medical disease which may interact with the objective of the study or with the safety of the subject, as judged by the investigator
- History of any psychiatric disease that could preclude reliable participation in the study, as judged by the investigator.
- Clinically significant illness within 2 weeks before the administration of the IMP as judged by the investigator.
- Donation of plasma from 2 weeks before Visit 1 or donation of blood from 3 months from Visit 1.
- Abnormal vital signs, laboratory test value or ECG of clinical significance, as judged by the investigator.
- Immunisation with live vaccine within the previous 3 months, for other vaccines within the past 30 days.
- Subjects with active infectious disease or infections that warrants special infection control measures, such as human immunodeficiency virus, tuberculosis, or chronic hepatitis B or C infection.
- History of alcohol or drug abuse within 2 years of entering the study
- History of positive test of covid-19 and as judged by the investigator.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.