Investigation on Safety, Tolerability, and Pharmacokinetics of Single Doses of NNC0113-0987 in Healthy Male Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01690169
First received: September 7, 2012
Last updated: July 23, 2013
Last verified: July 2013

September 7, 2012
July 23, 2013
September 2012
December 2012   (final data collection date for primary outcome measure)
Number of treatment emergent adverse events (TEAEs) [ Time Frame: From the dosing visit and until completion of the post-treatment follow-up visit (i.e. day 12-25) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01690169 on ClinicalTrials.gov Archive Site
  • Number and severity of hypoglycaemic episodes [ Time Frame: From dosing visit and until completion of the post-treatment follow-up visit (i.e. day 12-25) ] [ Designated as safety issue: No ]
  • AUC, the area under the NNC0113-0987 plasma concentration-time curve [ Time Frame: From dosing visit to infinity ] [ Designated as safety issue: No ]
  • Cmax, the maximum plasma concentration of NNC0113-0987 [ Time Frame: From dosing visit until last PK sampling visit (e.g. day 11) ] [ Designated as safety issue: No ]
  • tmax, the time to maximum plasma concentration of NNC0113-0987 [ Time Frame: From dosing visit until last PK sampling visit (e.g. day 11) ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Investigation on Safety, Tolerability, and Pharmacokinetics of Single Doses of NNC0113-0987 in Healthy Male Subjects
Investigation on Safety, Tolerability, and Pharmacokinetics of Single Doses of NNC0113-0987 in Healthy Male Subjects

This trial is conducted in Europe. The aim of the trial is to investigate safety, tolerability and pharmacokinetics (the exposure of the trial drug in the body) of single doses of NNC0113-0987 in healthy male subjects.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 2
  • Healthy
  • Drug: NNC0113-0987
    A single dose for oral administration, up to 7 dose levels will be investigated. If a non-tolerated dose level has been reached, the dose level will not be increased further.
  • Drug: placebo
    A single dose of oral placebo administered.
  • Experimental: NNC0113-0987
    Intervention: Drug: NNC0113-0987
  • Placebo Comparator: Placebo
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
December 2012
December 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male subjects with good general health as judged by the investigator, based on medical history, physical examination including 12-lead electrocardiogram (ECG), vital signs, and blood assessments at the screening visit
  • Body mass index (BMI) above or equal to 18.5 and below 30 kg/m^ 2

Exclusion Criteria:

  • Male subjects who are sexually active and not surgically sterilised, who or whose partner is unwilling to use two different forms of effective contraception, one of which has to be a barrier method (e.g., condom with spermicidal foam/gel/film/cream) for the duration of the trial and for 12 weeks following the last dose of trial medication
  • Participation in another trial within 90 days prior to screening
  • Subjects with a history of or presence of cancer, diabetes, or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal (including gastroesophageal reflux disease and irritable bowel syndrome), endocrinological, haematological, dermatological, venereal, neurological, or psychiatric disease or other major disorders that might have an impact on the current trial, as judged by the investigator
  • Subjects who are known to have hepatitis or who are carriers of the Hepatitis B surface antigen (HBsAg) or Hepatitis C antibodies, or have a positive result to the test for Human Immunodeficiency Virus (HIV) antibodies
  • History of acute idiopathic or chronic pancreatitis
Male
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01690169
NN9927-3909, 2012-000047-27, U1111-1126-7584
No
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Stine Just Maarbjerg Novo Nordisk A/S
Novo Nordisk A/S
July 2013

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