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

Phase 1

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 2; Healthy
• Interventions: Drug: placebo; Drug: semaglutide

• Registration Number: NCT02146079
• Lead Sponsor: 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), and the safety and tolerability of semaglutide in healthy male Japanese and Caucasian subjects.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05-21
• Study First Submitted: 2014-05-21
• Study First Submitted QC: 2014-05-21
• Study First Posted: 2014-05-23
• Primary Completion: 2014-10-20
• Study Completion: 2014-10-20
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-16
• Last Update Posted: 2018-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Semaglutide placebo 0.5 mg	placebo	-
Semaglutide placebo 1.0 mg	placebo	-
Semaglutide 1.0 mg	semaglutide	Dose-escalation trial
Semaglutide 0.5 mg	semaglutide	Dose-escalation trial

Primary Outcome Measures

Name	Time	Method
Area under the plasma semaglutide concentration-time curve	During a dosing interval (0-168 hours) at steady state

Secondary Outcome Measures

Name	Time	Method
Change in body weight from baseline to the end of treatment	Day 1 of Visit 2 (2-21 days after Visit 1), Day 92
Maximum observed plasma semaglutide concentration at steady state	0-168 hours after the last dose of semaglutide (0.5 and 1.0 mg)
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)

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇯🇵 Tokyo, Japan