Investigation of Optimal Dosing Conditions for NN9924 in Healthy Male Subjects
This study has been completed.
Sponsor:
Novo Nordisk
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01572753
First received: April 4, 2012
Last updated: September 11, 2012
Last verified: September 2012
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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
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