Investigation on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of a Long Acting GLP-1 Analogue (NNC0113-0987) in Healthy Male Subjects

Healthy Clinical Trial

Official title:

Investigation on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of a Long Acting GLP-1 Analogue (NNC0113-0987) in Healthy Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01967589
• Other study ID #: NN9926-3950
• Secondary ID: 2012-002893-30U1
• Status: Completed
• Phase: Phase 1
• First received: October 18, 2013
• Last updated: June 19, 2014
• Start date: October 2013
• Est. completion date: May 2014

Study information

• Verified date: June 2014
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

This trial is conducted in Europe. The aim of the trial is to investigate safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of multiple doses of a long acting GLP-1 analogue (NNC0113-0987) in healthy male subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

• Male, who is considered to be generally healthy, based on the medical history, physical examination and the results of vital signs, electrocardiogram (ECG) 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

• BMI (body mass index) 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 (GI), 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 type 2

• History of chronic pancreatitis or idiopathic acute pancreatitis

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

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

Study Design

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

Related Conditions & MeSH terms

• Diabetes
• Healthy

Intervention

Drug:
• NNC0113-0987
Once-daily doses for oral administration. Multiple doses with sequential dose increments over 10 weeks. Progression to next dose increment is based on a safety evaluation
• placebo
Once-daily doses for oral administration

Locations

Country	Name	City	State
n/a

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) recorded		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 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
Secondary	Time to maximum observed NNC0113-0987 plasma concentration		During a dosing interval (0-24 hours) at steady state (Day 67; Day 68 and Day 69)	No
Secondary	Change in fasting plasma glucose (FPG)		From baseline (Day 0, pre-dose) to after 10 weeks of treatment (Day 70)	No
Secondary	Change in HbA1C (glycosylated haemoglobin)		From baseline (Day 0, pre-dose) to after 10 weeks of treatment (Day 70)	No
Secondary	Change in body weight		From baseline (Day -1) to after 10 weeks of treatment (Day 70)	No

External Links

•   Clinical Trials at Novo Nordisk