Clinical trial NCT01967589: Investigation on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of a Long Acting GLP-1 Analogue (NNC0113-0987) in Healthy Male Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Healthy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2013-10-23
Enrollment: 82
Sex: MALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of treatment emergent adverse events (TEAEs) recorded
timeFrame: From the time of first dosing (Day 0) and until completion of the post-treatment follow-up visit (Day 83-97)
Secondary outcomes:
measure: Area under the NNC0113-0987 plasma concentration curve
timeFrame: During a dosing interval (0-24 hours) at steady state (Day 67; Day 68 and Day 69)
measure: Maximum observed NNC0113-0987 plasma concentration
timeFrame: During a dosing interval (0-24 hours) at steady state (Day 67; Day 68 and Day 69)
measure: Time to maximum observed NNC0113-0987 plasma concentration
timeFrame: During a dosing interval (0-24 hours) at steady state (Day 67; Day 68 and Day 69)
measure: Change in fasting plasma glucose (FPG)
timeFrame: From baseline (Day 0, pre-dose) to after 10 weeks of treatment (Day 70)
measure: Change in HbA1C (glycosylated haemoglobin)
timeFrame: From baseline (Day 0, pre-dose) to after 10 weeks of treatment (Day 70)
measure: Change in body weight
timeFrame: From baseline (Day -1) to after 10 weeks of treatment (Day 70)
Other outcomes:
Locations:
city: Harrow
country: United Kingdom
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References: