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

NCT ID: NCT02161588

Last Updated: 2014-12-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2014-11-30

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.

Conditions

Diabetes; Diabetes Mellitus, Type 2; Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Semaglutide

Group Type: EXPERIMENTAL

semaglutide

Intervention Type: DRUG

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

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

Once-daily oral administration as tablets.

Interventions

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.

Intervention Type: DRUG

placebo

Once-daily oral administration as tablets.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Tokyo, , Japan

Countries

Japan

Related Links

http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

U1111-1148-4141

Identifier Type: OTHER

Identifier Source: secondary_id

JapicCTI-142572

Identifier Type: OTHER

Identifier Source: secondary_id

NN9924-4140

Identifier Type: -

Identifier Source: org_study_id