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Clinical Trials/NCT00851773
NCT00851773
Completed
Phase 1

A Randomised, Double Blind, Placebo-controlled, Parallel-group, Multiple Doses, Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics Profiles of NN9535 in Healthy Male Japanese and Caucasian Subjects After Weekly Subcutaneous Injections.

Novo Nordisk A/S0 sites84 target enrollmentFebruary 2009
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ConditionsDiabetesHealthy
Interventionssemaglutideplacebo
Drugssemaglutideplacebo

Overview

Phase
Phase 1
Intervention
semaglutide
Conditions
Diabetes
Sponsor
Novo Nordisk A/S
Enrollment
84
Primary Endpoint
Adverse events
Status
Completed
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2009
End Date
October 2009
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •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

Exclusion Criteria

  • •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

Arms & Interventions

A

Intervention: semaglutide

B

Intervention: semaglutide

C

Intervention: semaglutide

D

Intervention: semaglutide

E

Intervention: semaglutide

F1

Intervention: placebo

F2

Intervention: placebo

F3

Intervention: placebo

F4

Intervention: placebo

F5

Intervention: placebo

Outcomes

Primary Outcomes

Adverse events

Time Frame: at all scheduled visits (2 - 14) following screening

Secondary Outcomes

  • 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))
  • Urinalysis(at all scheduled visits (2 - 14) including screening (visit 1))
  • Calcitonin(at screening (visit 1) and at visits 2, 9 and 14)
  • Antibody development against N9535(at visits 2 and 14)

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