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

Healthy Clinical Trial

Official title:

A Single-centre, Parallel-group, Randomised, Double-blind, Placebocontrolled, Multiple-dose Trial to Assess the Pharmacokinetics, Pharmacodynamics, and the Safety and Tolerability of Semaglutide in Healthy Male Japanese and Caucasian Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02146079
• Other study ID #: NN9535-3634
• Secondary ID: U1111-1147-6660J
• Status: Completed
• Phase: Phase 1
• First received: May 21, 2014
• Last updated: April 16, 2018
• Start date: May 21, 2014
• Est. completion date: October 20, 2014

Study information

• Verified date: April 2018
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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), and the safety and tolerability of semaglutide in healthy male Japanese and Caucasian subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: October 20, 2014
• Est. primary completion date: October 20, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 55 Years

Eligibility

Inclusion Criteria:

• Healthy male Japanese and Caucasian subjects

• Age between 20 and 55 years (both inclusive) at the time of signing informed consent

• Body weight of equal to or above 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%

• For Japanese subjects only: both parents Japanese

• For Caucasian subjects only: both parents Caucasian

Exclusion Criteria:

• Any clinically significant disease history, in the opinion of the investigator, or systemic or organ disease including: cardiological, pulmonary, gastrointestinal, hepatic, neurologic, renal, genitourinary and endocrine, dermatologic or hematologic diseases

• Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 (MEN2)

• History of chronic pancreatitis or idiopathic acute pancreatitis

• Calcitonin above or equal to 50 ng/L

• History of alcohol abuse within 1 year from screening, or a positive result in the alcohol breath test, or consumption of more than 21 units of alcohol weekly: 1 unit of alcohol equals approximately 250 mL of beer or lager, or approximately120 mL (one glass) of wine or Japanese sake, or approximately 20 mL of spirits

• 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 (randomisation), non-prescription drugs within 1 week prior to Visit 2 (randomisation). The use of vitamins, minerals and nutritional supplements, and the occasional use of paracetamol (acetaminophen) or acetylsalicylic acid are permitted

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Healthy

Intervention

Drug:
• semaglutide
Subjects will be randomised to receive either semaglutide 0.5 mg, semaglutide 0.5 mg placebo, semaglutide 1.0 mg or semaglutide 1.0 mg placebo within each group. Treatment with active drug or placebo blinded within each dose level. After randomisation, the subjects will follow a fixed dose escalation. The maintenance dose of 0.5 mg will be reached after 4 weeks of 0.25 mg. The maintenance dose of 1.0 mg will be reached after 8 weeks (4 weeks) of 0.25 mg and 4 weeks of 0.5 mg). Once-weekly subcutaneous (s.c., under the skin) administration. Trial duration per subject is 18 to 21 weeks depending on the individual subject's schedule
• placebo
Subjects will be randomised to receive either semaglutide 0.5 mg, semaglutide 0.5 mg placebo, semaglutide 1.0 mg or semaglutide 1.0 mg placebo within each group. Treatment with active drug or placebo blinded within each dose level. After randomisation, the subjects will follow a fixed dose escalation. The maintenance dose of 0.5 mg will be reached after 4 weeks of 0.25 mg. The maintenance dose of 1.0 mg will be reached after 8 weeks (4 weeks) of 0.25 mg and 4 weeks of 0.5 mg). Once-weekly subcutaneous (s.c., under the skin) administration. Trial duration per subject is 18 to 21 weeks depending on the individual subject's schedule.

Locations

Country	Name	City	State
Japan	Novo Nordisk Investigational Site	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Japan, 

References & Publications (1)

Ikushima I, Jensen L, Flint A, Nishida T, Zacho J, Irie S. A Randomized Trial Investigating the Pharmacokinetics, Pharmacodynamics, and Safety of Subcutaneous Semaglutide Once-Weekly in Healthy Male Japanese and Caucasian Subjects. Adv Ther. 2018 Mar 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the plasma semaglutide concentration-time curve		During a dosing interval (0-168 hours) at steady state
Secondary	Maximum observed plasma semaglutide concentration at steady state		0-168 hours after the last dose of semaglutide (0.5 and 1.0 mg)
Secondary	Change in body weight from baseline to the end of treatment		Day 1 of Visit 2 (2-21 days after Visit 1), Day 92
Secondary	Number of treatment emergent adverse events (TEAEs) from baseline to follow-up		From Day 1 of Visit 2 (2-21 days after Visit 1) to Day 120-127 (Visit 23)

External Links

•   Clinical Trials at Novo Nordisk