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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00851773
First received: February 25, 2009
Last updated: May 23, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Diabetes
Healthy
Drug: NN9535
Drug: placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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.

Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Adverse events [ Time Frame: at all scheduled visits (2 - 14) following screening ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Frequency of hypoglycaemic episodes [ Time Frame: at all scheduled visits (2 - 14) following screening ] [ Designated as safety issue: Yes ]
  • Vital signs (blood pressure and pulse) [ Time Frame: at all scheduled visits (2 - 14) including screening (visit 1) ] [ Designated as safety issue: No ]
  • 12-lead ECG (electrocardiogram) [ Time Frame: at all scheduled visits (2 - 14) including screening (visit 1) ] [ Designated as safety issue: No ]
  • Haematology [ Time Frame: at all scheduled visits (2 - 14) including screening (visit 1) ] [ Designated as safety issue: No ]
  • Biochemistry [ Time Frame: at all scheduled visits (2 - 14) including screening (visit 1) ] [ Designated as safety issue: No ]
  • Urinalysis [ Time Frame: at all scheduled visits (2 - 14) including screening (visit 1) ] [ Designated as safety issue: No ]
  • Calcitonin [ Time Frame: at screening (visit 1) and at visits 2, 9 and 14 ] [ Designated as safety issue: No ]
  • Antibody development against N9535 [ Time Frame: at visits 2 and 14 ] [ Designated as safety issue: No ]

Enrollment: 84
Study Start Date: February 2009
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: NN9535
0.1 mg once weekly, s.c. injection
Experimental: B Drug: NN9535
0.2 mg once weekly, s.c. injection
Experimental: C Drug: NN9535
0.4 mg once weekly, s.c. injection
Experimental: D Drug: NN9535
0.4 mg once weekly for 1 week, 0.8 mg once weekly for 7 weeks, s.c. injection
Experimental: E Drug: NN9535
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
Placebo Comparator: F1 Drug: placebo
0.1 mg once weekly, s.c. injection
Placebo Comparator: F2 Drug: placebo
0.2 mg once weekly, s.c. injection
Placebo Comparator: F3 Drug: placebo
0.4 mg once weekly, s.c. injection
Placebo Comparator: F4 Drug: placebo
0.4 mg once weekly for 1 week, 0.8 mg once weekly for 7 weeks, s.c. injection
Placebo Comparator: F5 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

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00851773

Locations
United Kingdom
London SW, United Kingdom, 17 0RE
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Jan Lynge, MSc, PhD Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00851773     History of Changes
Other Study ID Numbers: NN9535-3633, 2008-006325-13
Study First Received: February 25, 2009
Last Updated: May 23, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

ClinicalTrials.gov processed this record on July 24, 2014