Clinical trial NCT02235961: Investigate Safety, Tolerability and Pharmacokinetics for Single Doses of NNC9204-0530 Alone and in Combination With Liraglutide in Overweight to Obese But Otherwise Healthy Male Subjects
Official title: A First Human Dose Trial Investigating Safety, Tolerability and Pharmacokinetics for Single Doses of NNC9204-0530 Alone and in Combination With Liraglutide in Overweight to Obese But Otherwise Healthy Male Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Metabolism and Nutrition Disorder
Obesity
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2014-09-10
Enrollment: 163
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in the United States of America (USA). The aim of the trial is to investigate safety, tolerability and pharmacokinetics (the exposure of the trial drug in the body) for single doses of NNC9204-0530 alone and in combination with liraglutide in overweight to obese but otherwise healthy male subjects.


Eligibility criteria: Inclusion Criteria:

* Male, age between (both inclusive) 18 and 55 years at the time of signing inform consent
* Overweight or obese but otherwise healthy male subjects; BMI of between or equal to 27.0 and 35.0 kg/m\^2

Exclusion Criteria:

* Thyroid stimulating hormone values outside 0.4-6.0 mIU/l
* HbA1c (glycated hemoglobin) above or equal to 6.5%
* Any clinically relevant ECG (electrocardiogram) findings (e.g. 2nd or 3rd degree AV-block), in particular subjects with repeated demonstration of a QTcF (QT interval corrected by Fridericia formula) interval above 430 ms
* A history of additional risk factors for Torsades de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
* The use of concomitant medications that prolong the QT/QTc interval
* Obesity caused by endocrinology disorders (e.g. Cushing's Syndrome)
* Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
* Calcitonin above 50 ng/L
* History of pancreatitis (acute or chronic)

Primary outcomes:
measure: Number of treatment emergent adverse events recorded
timeFrame: From time of dosing of NNC9204-0530 (Day 1) until completion of the follow-up visit (Day 21-27)
Secondary outcomes:
measure: Area under the NNC9204-0530 serum concentration-time curve
timeFrame: From dosing visit to infinity calculated on 0-24 days NNC9204-0530 serum concentration-curve based on 21 sampling points
measure: Maximum concentration of NNC9204-0530 in serum
timeFrame: From dosing visit to infinity calculated on 0-24 days NNC9204-0530 serum concentration-curve based on 21 sampling points
measure: The time to maximum concentration of NNC9204-0530 in serum
timeFrame: From dosing visit to infinity calculated on 0-24 days NNC9204-0530 serum concentration-curve based on 21 sampling points
measure: The terminal half-life of NNC9204-0530
timeFrame: From dosing visit to infinity calculated on 0-24 days NNC9204-0530 serum concentration-curve based on 21 sampling points
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Novo Nordisk Investigational Site
state: Kansas
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References: