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A Research Study of How Oral Semaglutide Tablets Work in Healthy People Who Are Chinese

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ClinicalTrials.gov Identifier: NCT04016974
Recruitment Status : Not yet recruiting
First Posted : July 12, 2019
Last Update Posted : July 12, 2019
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Diabetes Mellitus, Type 2 Drug: Oral semaglutide Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Sponsor staff involved in the clinical trial is masked according to company standard procedures
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : August 1, 2019
Estimated Primary Completion Date : May 20, 2020
Estimated Study Completion Date : June 25, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Semaglutide

Arm Intervention/treatment
Experimental: Oral semaglutide Drug: Oral semaglutide
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 Comparator: Placebo Drug: Placebo
Placebo tablets once daily throughout the treatment period (day 1 to 84)




Primary Outcome Measures :
  1. AUC0-24h,sema,SS, area under the semaglutide concentration-time curve during a dosing interval (0−24 hours) at steady state [ 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


Secondary Outcome Measures :
  1. Cmax,sema,SS, maximum observed semaglutide plasma concentration during a dosing interval (0−24 hours) at steady state [ 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

  2. tmax,sema,SS, time to maximum observed semaglutide plasma concentration during a dosing interval (0−24 hours) at steady state [ 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

  3. CL/Fsema,SS, total apparent clearance of semaglutide at steady state [ 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

  4. Ctrough,sema,SS, trough semaglutide plasma concentration at steady state [ 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

  5. t½,sema,SS, terminal half-life of semaglutide at steady state [ Time Frame: After the last dose of oral semaglutide 14 mg on day 84 ]
    h

  6. Vss/Fsema, apparent volume of distribution of semaglutide at steady state [ Time Frame: After the last dose of oral semaglutide 14 mg on day 84 ]
    L

  7. MRTsema,SS, mean residence time of semaglutide at steady state [ Time Frame: After the last dose of oral semaglutide 14 mg on day 84 ]
    h

  8. Rtheor,sema,SS, theoretical accumulation index, which is defined as [1/(1-Exp (-λZ,sema,SS*24h))], where λZ,sema,SS=log(2)/t½,sema,SS [ Time Frame: After the last dose of oral semaglutide 14 mg on day 84 ]
    Index value

  9. Change in body weight from baseline [ Time Frame: Day 1, day 85 ]
    kg

  10. Change in fasting plasma glucose from baseline [ Time Frame: Day 1, day 85 ]
    mmol/l

  11. Number of treatment-emergent adverse events [ Time Frame: From the time of first dosing (day 1) until completion of the follow-up visit (day 119-121) ]
    Count

  12. Number of treatment-emergent hypoglycaemic episodes [ Time Frame: From the time of first dosing (day 1) until completion of the follow-up visit (day 119-121) ]
    Count



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Chinese male or female, aged 18-55 years (both inclusive) at the time of signing informed consent.
  • Body weight equal to or above 54.0 kg
  • Body mass index (BMI) between 20.0 and 24.9 kg/m^2 (both inclusive)
  • Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, ECG and clinical laboratory tests performed during the screening visit, as judged by the investigator.

Exclusion Criteria:

  • Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using highly effective contraceptive methods
  • History of pancreatitis (acute or chronic) as declared by the subject.
  • Family or personal history of multiple endocrine neoplasia type 2 (MEN2) or medullary thyroid carcinoma (MTC) as declared by the subject.
  • History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and in-situ carcinomas) as declared by the subject.
  • History of major surgical procedures involving the stomach potentially affecting absorption of trial product (e.g., subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery) as declared by the subject.
  • Smoker (defined as a subject who is smoking equal to or more than 1 cigarette or the equivalent per day).
  • Unable or unwilling to refrain from smoking and use of nicotine substitute products during the inpatient periods, as judged by the investigator.
  • Any blood draw in excess of 25 mL in the past month, or donation of blood or plasma in excess of 400 mL within the 3 months preceding screening.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04016974


Contacts
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Contact: Novo Nordisk (+1) 866-867-7178 clinicaltrials@novonordisk.com

Locations
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China
Novo Nordisk Investigational Site Not yet recruiting
Beijing, China, 100730
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Clinical Reporting Anchor and Disclosure (1452) Novo Nordisk A/S

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT04016974     History of Changes
Other Study ID Numbers: NN9924-4303
U1111-1186-6753 ( Other Identifier: World Health Organization (WHO) )
First Posted: July 12, 2019    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
URL: http://novonordisk-trials.com

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases