Safety, Tolerability, and Profile of Action of Drug in the Body of NN9535 in Healthy Male Japanese and Caucasian Subjects

NCT00851773 | Completed Phase 1

• 2 other identifiers: NN9535-36332008-006325-13
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

This trial is conducted in Europe. The aim of this clinical trial is to assess and compare the safety and tolerability, as assessed by adverse events after multiple subcutaneous doses of NN9535 in healthy male Japanese and Caucasian subjects.

Conditions

Diabetes; Healthy

Outcome Measures

Primary Outcomes (1)

• Adverse events

  at all scheduled visits (2 - 14) following screening

Secondary Outcomes (8)

• Frequency of hypoglycaemic episodes

  at all scheduled visits (2 - 14) following screening

• Vital signs (blood pressure and pulse)

  at all scheduled visits (2 - 14) including screening (visit 1)

• 12-lead ECG (electrocardiogram)

  at all scheduled visits (2 - 14) including screening (visit 1)

• Haematology

  at all scheduled visits (2 - 14) including screening (visit 1)

• Biochemistry

  at all scheduled visits (2 - 14) including screening (visit 1)

Study Arms (10)

A

EXPERIMENTAL

Drug: semaglutide

B

EXPERIMENTAL

Drug: semaglutide

C

EXPERIMENTAL

Drug: semaglutide

D

EXPERIMENTAL

Drug: semaglutide

E

EXPERIMENTAL

Drug: semaglutide

F1

PLACEBO COMPARATOR

Drug: placebo

F2

PLACEBO COMPARATOR

Drug: placebo

F3

PLACEBO COMPARATOR

Drug: placebo

F4

PLACEBO COMPARATOR

Drug: placebo

F5

PLACEBO COMPARATOR

Drug: placebo

Interventions

semaglutide DRUG

0.1 mg once weekly, s.c. injection

A

placebo DRUG

0.1 mg once weekly, s.c. injection

F1

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• For Caucasian or Japanese volunteers the following applies:
• Informed consent obtained before any trial-related activities
• Body weight between 54 and 90 kg (both inclusive)
• Body mass index (BMI) between 18.5 and 24.9 kg/m2 (both inclusive)
• HbA1c below 6.0 %
• Subjects who are considered to be generally healthy based on assessment of medical history, physical examination and clinical laboratory data at screening, as judged by the Investigator
• Subjects who are sexually active and have partners who are or could be pregnant are willing and required to use a barrier method of contraception (e.g. condom) for the duration of the study and for 90 days following the last dose of study medication
• Japanese passport holder, Japanese-born parents, lived outside Japan for 5 years or less

You may not qualify if:

• Any clinical laboratory values deviating from or outside the laboratory reference range unless considered not to be clinically significant by the investigator
• Any abnormal ECG findings at the screening, considered to be clinically significant by the Investigator
• Presence or history of diabetes, cancer or any clinically significant cardiac, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, dermatological, venereal, haematological, neurological, or psychiatric diseases or disorders, considered to be clinically significant by the Investigator
• Previous randomised in this trial (not applicable for stand-by volunteers)
• Blood pressure in supine position at the screening, after resting for 5 min, and in the standing position after standing for 1 min, consistently outside the ranges 90 - 140 mmHg systolic or 40 - 90 mmHg diastolic
• Heart rate in supine position at the screening, after resting for 5 min, consistently above 100 beats/min
• Alcohol intake within 48 hours prior to the screening and admission (examined by alcohol breath test)
• Hepatitis B surface antigen, Hepatitis C antibodies or Human Immunodeficiency Virus (HIV) antibodies positive
• History of significant allergy or hypersensitivity
• Known or suspected allergy to trial product or related products
• History of drug or alcohol abuse (alcohol abuse is defined as intake of more than 21 units (U) weekly: One unit of alcohol equals 1/2 pint (approximately 250 mL) of beer or lager, or one glass of wine or Japanese sake, or 1/6 gill (approximately 20 mL) of spirits)
• Subjects who smoke more than 10 cigarettes, or the equivalent, per day or is unwilling to refrain from smoking whenever required for the trial procedure
• Use of prescription drugs within 3 weeks prior to dosing, non-prescription drugs within 1 week prior to dosing except for vitamins, minerals and nutritional supplements
• Received any investigational drug within 12 weeks prior to the planned first dosing
• Subjects who have taken part in strenuous exercise within 48 hours prior to first dosing, due to interference with the hepatic microsomal monooxygenase system. The Investigator or Sub-Investigator will evaluate whether strenuous exercise has been undertaken

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Unknown Facility

London Southwest, 17 0RE, United Kingdom

Location

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2009
• First Posted: February 26, 2009
• Study Start: February 1, 2009
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: February 23, 2015

Record last verified: 2015-02

Locations

GB (1)