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A Trial to Assess the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Oral Semaglutide in Healthy Male Japanese and Caucasian Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02161588
Recruitment Status : Completed
First Posted : June 11, 2014
Last Update Posted : December 3, 2014
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
This trial is conducted in Asia. The aim of the trial is to investigate the pharmacokinetics (the exposure of the trial drug in the body), pharmacodynamics (the effect of the investigated drug on the body), safety and tolerability of oral semaglutide in healthy male Japanese and Caucasian subjects.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multiple Dose, Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Assess the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Oral Semaglutide in Healthy Male Japanese and Caucasian Subjects
Study Start Date : June 2014
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Semaglutide

Arm Intervention/treatment
Experimental: Semaglutide Drug: semaglutide
Once-daily oral administration as tablets. The dose level of oral semaglutide used in the 'Dose escalation period', 'Treatment period 1', 'Treatment period 2' and 'Treatment period 3' will be 5, 10, 20 and 40 mg per day, respectively.

Placebo Comparator: Placebo Drug: placebo
Once-daily oral administration as tablets.

Primary Outcome Measures :
  1. Area under the semaglutide plasma concentration-time curve [ Time Frame: During a dosing interval (0-24 hours) at steady state ]

Secondary Outcome Measures :
  1. Maximum observed semaglutide plasma concentration [ Time Frame: During a dosing interval (0-24 hours) at steady state ]
  2. Number of treatment emergent adverse events (TEAEs) recorded [ Time Frame: From the time of first dosing (Day 1) until completion of the follow-up visit (Days 119-126) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy male Japanese and Caucasian subjects
  • Age between 20 and 55 years (both inclusive) at time of signing informed consent
  • Body weight of above or equal to 54.0 kg
  • Body mass index (BMI) between 20.0 and 25.0 kg/m^2 (both inclusive)
  • Glycosylated haemoglobin A1c (HbA1c) below or equal to 6.0%

Exclusion Criteria:

  • Presence or history of diabetes, cancer or any clinically significant cardiac, respiratory, metabolic, renal, hepatic, GI (gastrointestinal), endocrine, dermatological, venereal, haematological, neurological, or psychiatric diseases or disorders, as judged by the investigator. Any disorder which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol
  • Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2)
  • History of chronic pancreatitis or idiopathic acute pancreatitis
  • Smoking of more than 5 cigarettes (including nicotine substitute products), or the equivalent, per day or unwilling to refrain from smoking whenever required for the trial procedure
  • Use of prescription drugs within 3 weeks or 5 times the half-life, whichever is longer, prior to Visit 2 (Day 1), non-prescription drugs within 1 week prior to Visit 2 (Day 1). The use of vitamins and minerals, and the occasional use of paracetamol (acetaminophen) or acetylsalicylic acid are permitted
  • Any blood drawn 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
  • Previous GI surgery such as invasive and corrective procedures involving the oesophagus, stomach, duodenum, gallbladder (e.g., cholecystectomy), pancreas or intestinal resections. Exempt are subjects that underwent uncomplicated surgical and diagnostic procedures such as appendectomy, hernia surgery, polypectomy, biopsies, as wells as colonic and gastric endoscopy

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 identifier (NCT number): NCT02161588

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Tokyo, Japan, 130-0004
Sponsors and Collaborators
Novo Nordisk A/S
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Additional Information:
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Responsible Party: Novo Nordisk A/S Identifier: NCT02161588    
Other Study ID Numbers: NN9924-4140
U1111-1148-4141 ( Other Identifier: WHO )
JapicCTI-142572 ( Other Identifier: JAPIC )
First Posted: June 11, 2014    Key Record Dates
Last Update Posted: December 3, 2014
Last Verified: December 2014
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases