Investigation on Safety, Tolerability and Pharmacokinetics of Multiple Doses of NNC0113-0987 in an Oral Formulation in Healthy Subjects

Healthy Clinical Trial

Official title:

Investigation on Safety, Tolerability and Pharmacokinetics of Multiple Doses of NNC0113-0987 in an Oral Formulation in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01978613
• Other study ID #: NN9927-4022
• Secondary ID: 2013-000188-10U1
• Status: Completed
• Phase: Phase 1
• First received: November 1, 2013
• Last updated: June 27, 2014
• Start date: November 2013
• Est. completion date: June 2014

Study information

• Verified date: June 2014
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• 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 multiple doses of NNC0113-0987 in an oral formulation in healthy subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

• Male subject, who is considered to be generally healthy, based on the medical history, physical examination, and the results of vital signs, electrocardiogram and laboratory safety tests performed during the screening visit, as judged by the investigator

• Age 18-64 years (both inclusive) at the time of signing informed consent

• Body mass index (BMI): 20.0-29.9 kg/m^2 (both inclusive)

Exclusion Criteria:

• 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, as judged by the investigator

• Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2

• History of chronic pancreatitis or idiopathic acute pancreatitis

• Subject with previous gastrointestinal surgery, except subjects that underwent uncomplicated surgical procedures such as appendectomy, hernia surgery, biopsies, as well as colonic and gastric endoscopy

• Use of prescription or non-prescription medicinal products and herbal products (except routine vitamins) within three weeks preceding the dosing period. Occasional use of paracetamol or acetylsalicylic acid is permitted

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Healthy

Intervention

Drug:
• NNC0113-0987
Tablets for once-daily oral administration. Multiple doses with sequential dose increments over 10 weeks. The end-dose levels and the dose levels during the escalation regime may be adapted during trial conduct based on safety evaluations.
• placebo
Tablets for one-daily oral administration.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of treatment emergent adverse events recorded		From the time of first dosing (day 0) and until completion of the post-treatment follow-up visit (day 83-97)	No
Secondary	Number of hypoglycaemic episodes		From the time of first dosing (day 0) and until completion of the post-treatment follow-up visit (day 83-97)	No
Secondary	Area under the NNC0113-0987 plasma concentration time curve		During a dosing interval (0-24 hours) at steady state (day 67, day 68 and day 69)	No
Secondary	Maximum observed NNC0113-0987 plasma concentration		During a dosing interval (0-24 hours) at steady state (day 67, day 68 and day 69)	No

External Links

•   Clinical Trials at Novo Nordisk