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)
Key facts
- Where
- Gothenburg, SvédországSee the site
- Phase
- 1/2. fázis
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 64 years old?
Where in Svédország
- Sahlgrenska University Hospital-Vaestra GoetalandsregionenGothenburg, SvédországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Vaestra Goetalandsregionen
- Trial code
- EU 2024-511124-14-00
- Record updated
- 2025. augusztus 27.
- Original description
The primary objective of this trial is to assess the safety and tolerability of GC and B following administration of multiple dosing.Read full original descriptionShow less
The primary objective of this trial is to assess the safety and tolerability of GC and B following administration of multiple dosing.
Inclusion: 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.
Exclusion: 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; Have previous (<12 months) treatments that may have had impact on bone metabolism; Previous enrolment or randomization in the present study; Participation in another clinical study with an IMP during the last 3 months prior to enrolment; 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; Immunisation with live vaccine within the previous 3 months, for other vaccines within the past 30 days; History of hypersensitivity and allergy, as judged by the investigator; Have other conditions that make principal investigator insecure on study participation; 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; 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; Abnormal vital signs, laboratory test value or ECG of clinical significance, as judged by the investigator; Women with a positive pregnancy test on enrolment or lactating women; Subjects not tolerating injections; Subjects not tolerating taste of IMP; Involvement in the planning, and/or conduct of the study.