Nottingham, NG11 6JS, United Kingdom
NCT Number: NCT01405261
Trial Investigating the Safety of NNC 0113-0987 in Healthy Male Subjects
This trial is conducted in Europe. The aim of this trial is to investigate safety, tolerability and pharmacokinetics (the exposure of the trial drug in the body) of single doses of NNC 0113-0987 in healthy male subjects.
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Notify MeKey information
Conditions
Age range
18 year–50 year
Sex eligibility
Male
Study type
Interventional
Phase
Phase 1
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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 and urinary laboratory assessments at the screening visit
- Body Mass Index (BMI) of minimum 18.5 and below 30 kg/m^2
Exclusion criteria
- Male subjects who are sexually active and not surgically sterilised, who or whose partner are 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 3 months following the last dose of trial medication
- The receipt of any investigational product within 90 days (or 5 half-lives of investigational drug, whichever is greater) prior to this trial (screening), or is currently enrolled in any other clinical trial
- Subjects with a history of or presence of cancer, diabetes, or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders that might have 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 chronic or idiopathic acute pancreatitis or amylase or lipase values above 3x upper normal range (UNR)
Treatment and study plan
oral NNC 0113-0987
DrugSubjects will be randomised to receive a single dose of NNC 0113-0987 at escalating dose levels. Progression to next dose will be based on safety evaluation.
I.v. NNC 0113-0987
DrugSubjects will be administered a single i.v (into the vein) dose. The treatment with NNC 0113-0987 will be open-label, and will not be randomised.
oral placebo
DrugSubjects will be randomised to receive a single dose of placebo.
Primary outcomes
-
Overview of Treatment Emergent Adverse Events (AEs)
Time frame: Up to 25 days after trial product administration
Secondary outcomes
-
Frequency of hypoglycaemic episodes
Time frame: From screening (day 1-21 before trial product administration) and until completion of the post treatment follow-up visit (day 12-25 after trial product administration)
-
AUC0-240h; area under the NNC 0113-0987 concentration-time curve
Time frame: From time 0 to 240 hours after a single oral or intravenous (i.v.) dose
-
AUC, area under the curve
Time frame: From time 0 to infinity after a single oral or i.v. dose
-
Cmax; maximum concentration of NNC 0113-0987 in plasma
Time frame: After a single oral or i.v. dose
-
The time to maximum concentration (tmax) of NNC 0113-0987 in plasma
Time frame: After a single oral dose
Sponsors and collaborators
Lead sponsor
Novo Nordisk A/S
Industry
Registry information
Official study title
Investigation on Safety, Tolerability, and Pharmacokinetics of Single Doses of a Long-acting GLP-1 Analogue in Healthy Male Subjects
Important dates
- Study start
- 2011
- Primary completion
- 2012
- Study completion
- 2012
- First posted
- Jul 29, 2011
- Registry last updated
- Nov 28, 2013
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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