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)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Vaestra Goetalandsregionen

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Musculoskeletal Diseases [C05], Diseases [C] - Digestive System Diseases [C06]

Trial duration

10 Dec 2024 → ongoing

Decision date (initial)

2024-05-28

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety

The primary objective of this trial is to assess the safety and tolerability of GC and B following administration of multiple dosing.

Secondary objectives 1

1. There is no secondary objective of this trial.

Conditions and MedDRA coding

Postoperative obesity

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Provision of signed and dated, written informed consent prior to any study specific procedures.
2. Healthy female and male subjects ≥20 years of age ≤65 years of age.
3. 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
4. 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
5. Females must have a negative pregnancy test and use anticonceptives.
6. Subjects must be able to understand and willing to comply with study procedures, restrictions and requirements as judged by the investigator.

Exclusion criteria 19

1. Women with a positive pregnancy test on enrolment or lactating women.
2. History of any psychiatric disease that could preclude reliable participation in the study, as judged by the investigator.
3. Clinically significant illness within 2 weeks before the administration of the IMP as judged by the investigator.
4. Donation of plasma from 2 weeks before Visit 1 or donation of blood from 3 months from Visit 1.
5. Abnormal vital signs, laboratory test value or ECG of clinical significance, as judged by the investigator.
6. Immunisation with live vaccine within the previous 3 months, for other vaccines within the past 30 days.
7. 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.
8. History of alcohol or drug abuse within 2 years of entering the study
9. History of positive test of covid-19 and as judged by the investigator.
10. History of hypersensitivity and allergy, as judged by the investigator
11. Subjects not tolerating injections.
12. 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.
13. Subjects not tolerating taste of IMP
14. Have previous (<12 months) treatments that may have had impact on bone metabolism.
15. Have other conditions that make principal investigator insecure on study participation.
16. Involvement in the planning, and/or conduct of the study
17. Previous enrolment or randomization in the present study
18. Participation in another clinical study with an IMP during the last 3 months prior to enrolment.
19. 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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Safety and tolerability

Secondary endpoints 3

1. PTH concentrations
2. Ca urinary excretion during 24 h
3. Bone resorption markers P1NP, CTX and BALP

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Vaestra Goetalandsregionen

Sponsor organisation

Vaestra Goetalandsregionen

Address

Regionens Hus

City

Vänersborg

Postcode

462 80

Country

Sweden

Scientific contact point

Organisation

Vaestra Goetalandsregionen

Contact name

Ville Wallenius

Public contact point

Organisation

Vaestra Goetalandsregionen

Contact name

Ville Wallenius

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 6 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications