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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01690169
• Other study ID #: NN9927-3909
• Secondary ID: 2012-000047-27U1
• Status: Completed
• Phase: Phase 1
• First received: September 7, 2012
• Last updated: February 24, 2017
• Start date: September 14, 2012
• Est. completion date: December 11, 2012

Study information

• Verified date: February 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: December 11, 2012
• Est. primary completion date: December 11, 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Healthy

Intervention

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
A single dose of oral placebo administered.

Locations

Country	Name	City	State
United Kingdom	Novo Nordisk Investigational Site	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of treatment emergent adverse events (TEAEs)		From the dosing visit and until completion of the post-treatment follow-up visit (i.e. day 12-25)
Secondary	Number and severity of hypoglycaemic episodes		From dosing visit and until completion of the post-treatment follow-up visit (i.e. day 12-25)
Secondary	AUC, the area under the NNC0113-0987 plasma concentration-time curve		From dosing visit to infinity
Secondary	Cmax, the maximum plasma concentration of NNC0113-0987		From dosing visit until last PK sampling visit (e.g. day 11)
Secondary	tmax, the time to maximum plasma concentration of NNC0113-0987		From dosing visit until last PK sampling visit (e.g. day 11)

External Links

•   Clinical Trials at Novo Nordisk