Investigation of Optimal Dosing Conditions for NN9924 in Healthy Male Subjects

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01572753
First received: April 4, 2012
Last updated: September 11, 2012
Last verified: September 2012
  Purpose

This trial is conducted in Europe. The aim of the trial is to evaluate the optimal dosing conditions for NN9924 in healthy male subjects.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Healthy
Drug: NN9924
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Investigation of Optimal Dosing Conditions for NN9924 in Healthy Male Subjects

Resource links provided by NLM:


Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • AUC0-24hrs, Day10: Area under the NN9924 concentration curve [ Time Frame: From time 0-24hrs after the 10th dosing ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cmax, Day10: The maximum plasma NN9924 concentration [ Time Frame: After 10 days of dosing ] [ Designated as safety issue: No ]
  • tmax, Day10 : Time to maximum plasma NN9924 concentration [ Time Frame: After 10 days of dosing ] [ Designated as safety issue: No ]
  • t½, Day10: The terminal half-life of NN9924 [ Time Frame: After 10 days of dosing ] [ Designated as safety issue: No ]

Enrollment: 157
Study Start Date: April 2012
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Post-dose fasting 120 mins/50 ml water Drug: NN9924
Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing). Dose to be taken with 50 ml of water. During the post-dose fasting period of 120 mins, no food or liquid is allowed.
Experimental: Post-dose fasting 60 mins/50 ml water Drug: NN9924
Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing). Dose to be taken with 50 ml of water. During the post-dose fasting period of 60 mins, no food or liquid is allowed.
Experimental: Post-dose fasting 30 mins/50 ml water Drug: NN9924
Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing). Dose to be taken with 50 ml of water. During the post-dose fasting period of 30 mins, no food or liquid is allowed.
Experimental: Post-dose fasting 15 mins/50 ml water Drug: NN9924
Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing). Dose to be taken with 50 ml of water. During the post-dose fasting period of 15 mins, no food or liquid is allowed.
Experimental: Post-dose fasting 120 mins/120 ml water Drug: NN9924
Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing). Dose to be taken with 120 ml of water. During the post-dose fasting period of 120 mins, no food or liquid is allowed.
Experimental: Post-dose fasting 60 mins/120 ml water Drug: NN9924
Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing). Dose to be taken with 120 ml of water. During the post-dose fasting period of 60 mins, no food or liquid is allowed.
Experimental: Post-dose fasting 30 mins/120 ml water Drug: NN9924
Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing). Dose to be taken with 120 ml of water. During the post-dose fasting period of 30 mins, no food or liquid is allowed.
Experimental: Post-dose fasting 15 mins/120 ml water Drug: NN9924
Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing). Dose to be taken with 120 ml of water. During the post-dose fasting period of 15 mins, no food or liquid is allowed.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Good general health as judged by the trial physician, based on medical history, physical examination, electrocardiogram (ECG), vital signs and clinical laboratory
  • Body mass index (BMI) of 18.5-30.0 kg/m^2 (both inclusive)

Exclusion Criteria:

  • Males who are sexually active and not surgically sterilised, who or whose partner(s): a. are not using adequate contraceptive methods (e.g. condom with spermicidal foam/gel/film/cream or contraceptives with a Pearl Index below 1%, such as implants, injectables, combined oral contraceptives, or hormonal intrauterine devices or diaphragm + spermicide) or b. do not refrain from sexual intercourse during the trial and until 30 days following the last dose of trial medication. In addition, subjects must not donate sperm for the duration of the trial and for 30 days following the last dose of trial medication
  • Suffer from a life threatening disease or has a history of any clinically significant disease or disorder
  • History of acute idiopathic or chronic pancreatitis
  • Calcitonin value equal to or above 50 ng/L
  • Any clinically significant abnormal laboratory test results (haematology, biochemistry and urinalysis), as judged by the trial physician and any of the following laboratory safety results (based on screening results): Amylase, lipase and creatinine, above upper normal range. Aspartate aminotransferase (ASAT), alanine aminotransferase (ALAT) and gamma-glutamyl-transpeptidase (gamma-GT) above 1.5 times upper normal range (UNR). Thrombocytes below 0.75 times lower normal range (LNR) or above 1.25 times UNR. Leucocytes outside 3.0 to 11.0x10^9/L (normal range is 3.91 to 8.77x10^9/L. Sodium outside the range 130.0 to 150.0 mmol/L (normal range is 136-145 mmol/L). Potassium outside the range 3.0 to 5.5 mmol/L (normal range is 3.5 to 5.1 mmol/L)
  • Any clinically significant abnormal electrocardiogram (ECG), as judged by the trial physician
  • Subjects who are smokers
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01572753

Locations
Germany
Berlin, Germany, 14050
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Tine Aggerholm Bækdal Novo Nordisk
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01572753     History of Changes
Other Study ID Numbers: NN9924-3794, 2010-019653-17, U1111-1120-6776
Study First Received: April 4, 2012
Last Updated: September 11, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 23, 2013