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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01690169
First Posted: September 21, 2012
Last Update Posted: February 28, 2017
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.
Information provided by (Responsible Party):
Novo Nordisk A/S
  Purpose
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.

Condition Intervention Phase
Diabetes Diabetes Mellitus, Type 2 Healthy Drug: NNC0113-0987 Drug: placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Investigation on Safety, Tolerability, and Pharmacokinetics of Single Doses of NNC0113-0987 in Healthy Male Subjects

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

Primary Outcome Measures:
  • 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) ]

Secondary Outcome Measures:
  • 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) ]
  • AUC, the area under the NNC0113-0987 plasma concentration-time curve [ Time Frame: From dosing visit to infinity ]
  • Cmax, the maximum plasma concentration of NNC0113-0987 [ Time Frame: From dosing visit until last PK sampling visit (e.g. day 11) ]
  • tmax, the time to maximum plasma concentration of NNC0113-0987 [ Time Frame: From dosing visit until last PK sampling visit (e.g. day 11) ]

Enrollment: 45
Actual Study Start Date: September 14, 2012
Study Completion Date: December 11, 2012
Primary Completion Date: December 11, 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NNC0113-0987 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.
Placebo Comparator: Placebo Drug: placebo
A single dose of oral placebo administered.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01690169


Locations
United Kingdom
Novo Nordisk Investigational Site
Nottingham, United Kingdom, NG11 6JS
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR,1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01690169     History of Changes
Other Study ID Numbers: NN9927-3909
2012-000047-27 ( EudraCT Number )
U1111-1126-7584 ( Other Identifier: WHO )
First Submitted: September 7, 2012
First Posted: September 21, 2012
Last Update Posted: February 28, 2017
Last Verified: February 2017

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