2023-503949-65-00CompletedPhase 1
A research study comparing the effect of different dosing conditions on blood levels of semaglutide in a new tablet composition in healthy participants
Investigation of the effect of dosing conditions on the pharmacokinetics of new oral semaglutide formulation in healthy participants
Source: EU CTIS (euclinicaltrials.eu) · Last updated 12 Dec 2023
Brief summary (registry, in English)
To compare the effect of water volume and post-dose fasting period on the pharmacokinetics of semaglutide in healthy participants treated with oral semaglutide D for 10 days
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 120 (actual)
- First submitted
- 29 May 2023
- Start date
- 7 Aug 2023
- Lead sponsor
- Novo Nordisk A/S
- EU CT number
- 2023-503949-65-00
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 120
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of tobacco and nicotine products, defined as any of the below: 1. Smoking more than 5 cigarettes or the equivalent per day 2. Not willing to refrain from smoking and use of nicotine substitute products within 48 hours prior to and during the inpatient periods.
- History (as declared by the participant or reported in the medical records) of major surgical procedures involving the stomach potentially affecting absorption of trial products (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery) or current presence of gastrointestinal implant.
Other illness
- Presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs and/or nutrients, as judged by the investigator.
- Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma (as declared by the participant or reported in the medical records)
Lab values
- HbA1c ≥ 6.5 % (48 mmol/mol) at screening.
Who the study is looking for
- Body mass index (BMI) between 18.5 and 29.9 kg/m2 (both inclusive).
- Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.
Age in the registry: 18 years to 64 years · Sex: Male · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| PROFIL Institut fuer Stoffwechselforschung GmbH | Neuss | Germany | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.