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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00851773
Recruitment Status : Completed
First Posted : February 26, 2009
Last Update Posted : February 23, 2015
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Tracking Information
First Submitted Date  ICMJE February 25, 2009
First Posted Date  ICMJE February 26, 2009
Last Update Posted Date February 23, 2015
Study Start Date  ICMJE February 2009
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 25, 2009)
Adverse events [ Time Frame: at all scheduled visits (2 - 14) following screening ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 25, 2009)
  • Frequency of hypoglycaemic episodes [ Time Frame: at all scheduled visits (2 - 14) following screening ]
  • Vital signs (blood pressure and pulse) [ Time Frame: at all scheduled visits (2 - 14) including screening (visit 1) ]
  • 12-lead ECG (electrocardiogram) [ Time Frame: at all scheduled visits (2 - 14) including screening (visit 1) ]
  • Haematology [ Time Frame: at all scheduled visits (2 - 14) including screening (visit 1) ]
  • Biochemistry [ Time Frame: at all scheduled visits (2 - 14) including screening (visit 1) ]
  • Urinalysis [ Time Frame: at all scheduled visits (2 - 14) including screening (visit 1) ]
  • Calcitonin [ Time Frame: at screening (visit 1) and at visits 2, 9 and 14 ]
  • Antibody development against N9535 [ Time Frame: at visits 2 and 14 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety, Tolerability, and Profile of Action of Drug in the Body of NN9535 in Healthy Male Japanese and Caucasian Subjects
Official Title  ICMJE 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.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetes
  • Healthy
Intervention  ICMJE
  • Drug: semaglutide
    0.1 mg once weekly, s.c. injection
  • Drug: semaglutide
    0.2 mg once weekly, s.c. injection
  • Drug: semaglutide
    0.4 mg once weekly, s.c. injection
  • Drug: semaglutide
    0.4 mg once weekly for 1 week, 0.8 mg once weekly for 7 weeks, s.c. injection
  • Drug: semaglutide
    0.4 mg once weekly for 1 week, 0.8 mg once weekly for 1 week, 1.2 mg once weekly for 6 weeks, s.c. injection
    Other Name: NN9535
  • Drug: placebo
    0.1 mg once weekly, s.c. injection
  • Drug: placebo
    0.2 mg once weekly, s.c. injection
  • Drug: placebo
    0.4 mg once weekly, s.c. injection
  • Drug: placebo
    0.4 mg once weekly for 1 week, 0.8 mg once weekly for 7 weeks, s.c. injection
  • Drug: placebo
    0.4 mg once weekly for 1 week, 0.8 mg once weekly for 1 week, followed by 1.2 mg once weekly injections for 6 weeks, s.c. injection
Study Arms  ICMJE
  • Experimental: A
    Intervention: Drug: semaglutide
  • Experimental: B
    Intervention: Drug: semaglutide
  • Experimental: C
    Intervention: Drug: semaglutide
  • Experimental: D
    Intervention: Drug: semaglutide
  • Experimental: E
    Intervention: Drug: semaglutide
  • Placebo Comparator: F1
    Intervention: Drug: placebo
  • Placebo Comparator: F2
    Intervention: Drug: placebo
  • Placebo Comparator: F3
    Intervention: Drug: placebo
  • Placebo Comparator: F4
    Intervention: Drug: placebo
  • Placebo Comparator: F5
    Intervention: Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 26, 2009)
84
Original Estimated Enrollment  ICMJE
 (submitted: February 25, 2009)
112
Actual Study Completion Date  ICMJE October 2009
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
  • 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
  • Loss of more than 400 mL blood in total within the last 12 weeks or more than 200 mL blood in total within the last 4 weeks prior to first dosing
  • Subjects with a first-degree relative with diabetes mellitus
  • Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
  • Possibility that the subject will not comply with the protocol
  • Subjects who in the opinion of the Investigator or Sub-Investigator should not participate in the trial
  • Subjects with known history of either Type 1 or Type 2 diabetes mellitus are excluded
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 20 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00851773
Other Study ID Numbers  ICMJE NN9535-3633
2008-006325-13 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novo Nordisk A/S
Study Sponsor  ICMJE Novo Nordisk A/S
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
PRS Account Novo Nordisk A/S
Verification Date February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP