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

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Healthy; Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: placebo; Drug: semaglutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT02146079

NN9535-3634

U1111-1147-6660 (Other Identifier)

JapicCTI-142550 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 44 patients

Sex: Male

Ages: 20 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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44 participants in 4 patient groups, including a placebo group

Semaglutide 0.5 mg

Experimental group

Description:

Dose-escalation trial

Treatment:

Drug: semaglutide

Semaglutide placebo 0.5 mg

Placebo Comparator group

Treatment:

Drug: placebo

Semaglutide 1.0 mg

Experimental group

Description:

Dose-escalation trial

Treatment:

Drug: semaglutide

Semaglutide placebo 1.0 mg

Placebo Comparator group

Treatment:

Drug: placebo