- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03466567
A Trial Investigating the Effect of Probenecid and Ciclosporin on the Concentrations of SNAC in Healthy Subjects
A Trial Investigating the Effect of Probenecid and Ciclosporin on the Pharmacokinetics of SNAC in Healthy Subjects
The aim of the study is to investigate the effect of the medicines, probenecid and ciclosporin on the concentrations of SNAC. SNAC is an ingredient of the semaglutide tablets. Participants will get 3 different treatments (that is 3 treatment periods): 1) a single dose of 3 mg semaglutide, 2) a single dose of 600 mg ciclosporin with 3 mg semaglutide, 3) 500 mg probenecid twice a day for 3 ½ days with a single dose of 3 mg semaglutide on the last day.
The sequence of treatments participants get is decided by chance. Probenecid and ciclosporin are available medicines. They are given by doctors. Semaglutide contains SNAC. It cannot be prescribed yet.
The study will last for up to 125 days. Participants will have 17 to 18 visits at the study centre. This includes short visits at the centre for blood sampling only. Participants will have several blood draws.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
-
Berlin, Germany, 14050
- Novo Nordisk INvestigational Site
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male or female of non-childbearing potential, aged 18-64 years (both inclusive) at the time of signing informed consent.
- Body mass index between 18.5 and 29.9 kg/sqm (both inclusive).
- Body weight greater than or equal to 50.0 kg.
- 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.
Exclusion Criteria:
- Use of tobacco and nicotine products, defined as: A. Smoking more than 1 cigarette or the equivalent per day B. Not able or willing to refrain from smoking and use of nicotine substitute products during the in-house period(s).
- Presence of clinically significant gastrointestinal disorders or symptoms of gastrointestinal disorders potentially affecting absorption of drugs or nutrients, as judged by the investigator.
- History (as declared by the subject) of major surgical procedures involving the stomach potentially affecting absorption of trial products (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery).
- Known glucose-6-phosphate-dehydrogenase deficiency (as declared by the subject).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Oral semaglutide, ciclosporin, probenecid
Participants will receive oral semaglutide in treatment period 1, ciclosporin in treatment period 2, and probenecid in treatment period 3.
|
A single dose of 3 mg semaglutide tablet alone will be administered orally.
Trial product administration will take place in the morning after overnight fasting for at least 6 hours.
A dose of 500 mg probenecid (2 tablets of 250 mg) will be administered orally twice daily for 3½ days (7 trial product administrations in total).
On the 4th day, the last probenecid administration will take place 2 hours prior to administration of a single dose of 3 mg oral semaglutide tablet.
The last trial product administrations will take place in the morning after overnight fasting for at least 6 hours.
A single dose of 600 mg ciclosporin (6 capsules of 100 mg) will be administered orally 1 hour prior to administration of a single dose of 3 mg oral semaglutide tablet.
Trial product administration will take place in the morning after overnight fasting for at least 6 hours.
|
Experimental: Probenecid, oral semaglutide, ciclosporin
Participants will receive probenecid in treatment period 1, oral semaglutide in treatment period 2, and ciclosporin in treatment period 3.
|
A single dose of 3 mg semaglutide tablet alone will be administered orally.
Trial product administration will take place in the morning after overnight fasting for at least 6 hours.
A dose of 500 mg probenecid (2 tablets of 250 mg) will be administered orally twice daily for 3½ days (7 trial product administrations in total).
On the 4th day, the last probenecid administration will take place 2 hours prior to administration of a single dose of 3 mg oral semaglutide tablet.
The last trial product administrations will take place in the morning after overnight fasting for at least 6 hours.
A single dose of 600 mg ciclosporin (6 capsules of 100 mg) will be administered orally 1 hour prior to administration of a single dose of 3 mg oral semaglutide tablet.
Trial product administration will take place in the morning after overnight fasting for at least 6 hours.
|
Experimental: Ciclosporin, probenecid, oral semaglutide
Participants will receive ciclosporin in treatment period 1, probenecid in treatment period 2, and oral semaglutide in treatment period 3.
|
A single dose of 3 mg semaglutide tablet alone will be administered orally.
Trial product administration will take place in the morning after overnight fasting for at least 6 hours.
A dose of 500 mg probenecid (2 tablets of 250 mg) will be administered orally twice daily for 3½ days (7 trial product administrations in total).
On the 4th day, the last probenecid administration will take place 2 hours prior to administration of a single dose of 3 mg oral semaglutide tablet.
The last trial product administrations will take place in the morning after overnight fasting for at least 6 hours.
A single dose of 600 mg ciclosporin (6 capsules of 100 mg) will be administered orally 1 hour prior to administration of a single dose of 3 mg oral semaglutide tablet.
Trial product administration will take place in the morning after overnight fasting for at least 6 hours.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
AUC0-tz,SNAC,SD, area under the SNAC plasma concentration-time curve from time 0 to time of the last quantifiable concentration after a single dose of oral semaglutide
Time Frame: 0-48 hours
|
Calculated based on plasma SNAC activity measured in blood.
|
0-48 hours
|
Cmax,SNAC,SD, maximum observed SNAC plasma concentration on the concentration-time curve after a single dose of oral semaglutide
Time Frame: 0-48 hours
|
Calculated based on plasma SNAC activity measured in blood.
|
0-48 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
AUC0-tz,E494,SD, area under the SNAC metabolite E494 plasma concentration-time curve from time 0 to time of the last quantifiable concentration after a single dose of oral semaglutide
Time Frame: 0-48 hours
|
Calculated based on plasma SNAC metabolite E494 activity measured in blood.
|
0-48 hours
|
Cmax,E494,SD, maximum observed SNAC metabolite E494 plasma concentration on the concentration-time curve after a single dose of oral semaglutide
Time Frame: 0-48 hours
|
Calculated based on plasma SNAC metabolite E494 activity measured in blood.
|
0-48 hours
|
AUC0-tz,E506,SD, area under the SNAC metabolite E506 plasma concentration-time curve from time 0 to time of the last quantifiable concentration after a single dose of oral semaglutide
Time Frame: 0-48 hours
|
Calculated based on plasma SNAC metabolite E506 activity measured in blood.
|
0-48 hours
|
Cmax,E506,SD, maximum observed SNAC metabolite E506 plasma concentration on the concentration-time curve after a single dose of oral semaglutide
Time Frame: 0-48 hours
|
Calculated based on plasma SNAC metabolite E506 activity measured in blood.
|
0-48 hours
|
AUC0-∞,E1245,SD, area under the SNAC metabolite E1245 plasma concentration-time curve from time 0 to infinity after a single dose of oral semaglutide
Time Frame: 0-48 hours
|
Calculated based on plasma SNAC metabolite E1245 activity measured in blood.
|
0-48 hours
|
Cmax,E1245,SD, maximum observed SNAC metabolite E1245 plasma concentration on the concentration-time curve after a single dose of oral semaglutide
Time Frame: 0-48 hours
|
Calculated based on plasma SNAC metabolite E1245 activity measured in blood.
|
0-48 hours
|
AUC0-∞,E1246,SD, area under the SNAC metabolite E1246 plasma concentration-time curve from time 0 to infinity after a single dose of oral semaglutide
Time Frame: 0-48 hours
|
Calculated based on plasma SNAC metabolite E1246 activity measured in blood.
|
0-48 hours
|
Cmax,E1246,SD, maximum observed SNAC metabolite E1246 plasma concentration on the concentration-time curve after a single dose of oral semaglutide
Time Frame: 0-48 hours
|
Calculated based on plasma SNAC metabolite E1246 activity measured in blood.
|
0-48 hours
|
AUC0-∞,E1247,SD, area under the SNAC metabolite E1247 plasma concentration-time curve from time 0 to infinity after a single dose of oral semaglutide
Time Frame: 0-48 hours
|
Calculated based on plasma SNAC metabolite E1247 activity measured in blood.
|
0-48 hours
|
Cmax,E1247,SD, maximum observed SNAC metabolite E1247 plasma concentration on the concentration-time curve after a single dose of oral semaglutide
Time Frame: 0-48 hours
|
Calculated based on plasma SNAC metabolite E1247 activity measured in blood.
|
0-48 hours
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antirheumatic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Dermatologic Agents
- Antifungal Agents
- Gout Suppressants
- Calcineurin Inhibitors
- Renal Agents
- Uricosuric Agents
- Cyclosporine
- Cyclosporins
- Probenecid
Other Study ID Numbers
- NN9924-4394
- U1111-1197-9088 (Other Identifier: World Health Organization (WHO))
- 2017-002498-21 (Registry Identifier: European Medicines Agency (EudraCT))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Diabetes Mellitus, Type 2
-
SanofiCompletedType 1 Diabetes Mellitus-Type 2 Diabetes MellitusHungary, Russian Federation, Germany, Poland, Japan, United States, Finland
-
Mannkind CorporationTerminatedType 2 Diabetes Mellitus | Type 1 Diabetes MellitusUnited States
-
Griffin HospitalCalifornia Walnut CommissionCompletedDIABETES MELLITUS TYPE 2United States
-
Scripps Whittier Diabetes InstituteSan Diego State UniversityCompletedType 2 Diabetes Mellitus (T2DM)United States
-
RWTH Aachen UniversityBoehringer IngelheimCompletedDiabetes Mellitus Type 2 (T2DM)Germany
-
US Department of Veterans AffairsAmerican Diabetes AssociationCompletedType 2 Diabetes MellitusUnited States
-
Dexa Medica GroupCompletedType-2 Diabetes MellitusIndonesia
-
AstraZenecaNot yet recruiting
-
Daewoong Pharmaceutical Co. LTD.Not yet recruitingT2DM (Type 2 Diabetes Mellitus)
-
Zhongda HospitalRecruitingType 2 Diabetes Mellitus (T2DM)China
Clinical Trials on Semaglutide
-
Novo Nordisk A/SCompletedObesity | OverweightUnited States, India, Japan, Russian Federation, United Kingdom, Canada, Spain, South Africa, Germany, Greece, United Arab Emirates, Argentina, Puerto Rico
-
Novo Nordisk A/SCompletedDiabetes Mellitus, Type 2Germany
-
Novo Nordisk A/SCompletedType 2 Diabetes | Healthy VolunteersUnited States, Canada
-
Novo Nordisk A/SActive, not recruitingDiabetes Mellitus, Type 2 | Peripheral Arterial DiseaseSpain, Taiwan, China, India, United States, Canada, Thailand, Austria, Malaysia, Germany, Poland, Japan, Czechia, Greece, Belgium, Denmark, Hungary, Latvia, Norway, Sweden
-
Novo Nordisk A/SCompletedObesityUnited States, Israel, United Kingdom, Denmark, Germany, Netherlands, Canada, Argentina, Czechia, Hungary, Poland, Spain, Australia
-
Novo Nordisk A/SCompletedObesity | Diabetes Mellitus, Type 2 | OverweightKorea, Republic of, Hong Kong, Brazil, China
-
Novo Nordisk A/SCompletedObesity | OverweightUnited States
-
Novo Nordisk A/SCompletedObesity | OverweightUnited States, Italy, Spain, Canada, Hungary
-
Novo Nordisk A/SCompletedObesity | OverweightJapan, Korea, Republic of
-
Novo Nordisk A/SCompletedOverweight or Obesity | Metabolism and Nutrition DisorderUnited States, India, Mexico, Russian Federation, United Kingdom, Canada, Denmark, Finland, Belgium, Japan, Taiwan, France, Poland, Germany, Bulgaria, Argentina, Puerto Rico