Beijing Hospital-phase I
Beijing, Beijing Municipality, 100730, China
NCT Number: NCT04016974
This study looks at the way a new medicine tablet called semaglutide moves in and throughout the body over time. It will also look at if the medicine is safe and the body can accept it. The new medicine is planned to treat diabetes. The aim of the study is to see how semaglutide tablets work in healthy people who are Chinese. Participants will either get oral semaglutide tablets or placebo (dummy) tablets - which treatment is decided by chance. The tablet form of semaglutide is a new medicine that cannot be prescribed. Doctors can prescribe semaglutide as an injection only. It is for the treatment of diabetes in some countries. Participants will get 1 tablet per day for 12 weeks (84 days). Participants will get 1 tablet a day to take with up to half a glass of water (maximum 120 mL). Participants must take the tablet first thing in the morning on an empty stomach (water is allowed until 2 hours before taking the tablet). After taking the tablet, participants must not eat or drink anything for at least 30 minutes. After 30 minutes, they can have their first meal of the day and take any other medicines they may need, such as birth control tablets, routine vitamins and use of paracetamol at times.
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Beijing, Beijing Municipality, 100730, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Semaglutide tablets once daily as follows: 3 mg for the first treatment period (day 1-28), followed by 7 mg in the second treatment period (day 29-56), followed by 14 mg in the third treatment period (day 57-84)
Placebo tablets once daily throughout the treatment period (day 1 to 84)
Time frame: After the last dose of oral semaglutide at dose levels of 3 mg on day 28 and 7 mg on day 56, and after the last 3 daily doses of oral semaglutide at dose level 14 mg on day 82, 83 and 84
h*nmol/L
Time frame: After the last dose of oral semaglutide at dose levels of 3 mg on day 28 and 7 mg on day 56, and after the last 3 daily doses of oral semaglutide at dose level 14 mg on day 82, 83 and 84
nmol/L
Time frame: After the last dose of oral semaglutide at dose levels of 3 mg on day 28 and 7 mg on day 56, and after the last 3 daily doses of oral semaglutide at dose level 14 mg on day 82, 83 and 84
h
Time frame: After the last dose of oral semaglutide at dose levels of 3 mg on day 28 and 7 mg on day 56, and after the last 3 daily doses of oral semaglutide at dose level 14 mg on day 82, 83 and 84
L/h
Time frame: After the last 3 daily doses of oral semaglutide administration at 3, 7 and 14 mg dose levels on day 27-29, 55-57 and 83-85
nmol/L
Time frame: After the last dose of oral semaglutide 14 mg on day 84
h
Time frame: After the last dose of oral semaglutide 14 mg on day 84
L
Time frame: After the last dose of oral semaglutide 14 mg on day 84
h
Time frame: After the last dose of oral semaglutide 14 mg on day 84
Index value
Time frame: Day 1, day 85
kg
Time frame: Day 1, day 85
mmol/l
Time frame: From the time of first dosing (day 1) until completion of the follow-up visit (day 119-121)
Count
Time frame: From the time of first dosing (day 1) until completion of the follow-up visit (day 119-121)
Count
Novo Nordisk A/S
Industry
A Multiple-dose, Single-centre, Randomised, Double-blind, Placebo-controlled Trial to Investigate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Oral Semaglutide in Healthy Chinese Subjects
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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