Harrow, HA1 3UJ, United Kingdom
NCT Number: NCT02094521
Evaluation of Optimal Dosing Conditions for GLP-1 Analogue NNC0113-0987 When Administered Orally in Healthy Male Subjects
This trial is conducted in Europe. The aim of the trial is to evaluate the optimal dosing conditions for GLP-1 analogue NNC0113-0987 when administered orally in healthy male subjects.
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Notify MeKey information
Conditions
Age range
18 year–55 year
Sex eligibility
Male
Study type
Interventional
Phase
Phase 1
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Male aged 18 between 55 years (both inclusive) at the time of signing informed consent
- Good general health based on medical history, physical examination, and results of vital signs, electrocardiogram and laboratory safety tests performed during the screening visit, as judged by the investigator
- Body mass index (BMI) between 18.5 and 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
- Blood pressure above 140 mmHg systolic and/or above 90 mmHg diastolic or pulse above 90 beats per minute at the screening visit
- Smoking more than 5 cigarettes or the equivalent per day (including use of nicotine substitute products)
- History of significant drug abuse, or a positive drug test at the screening visit
- Any blood draw in excess of 25 mL in the past month, or donation of blood or plasma in excess of 400 mL within the 3 months preceding the screening visit
Treatment and study plan
NNC0113-0987
DrugFor oral administration. All subjects will be treated for 10 consecutive days with five days on 5 mg NNC0113-0987 followed by five days on 10 mg NNC0113-0987. Dose escalation is chosen to increase gastrointestinal tolerability.
Primary outcomes
-
Area under the NNC0113-0987 plasma concentration time curve
Time frame: From time 0 to 24 hours after the 10th dosing
Secondary outcomes
-
Maximum observed NNC0113-0987 plasma concentration
Time frame: 0 to 24 hours after the 10th dosing
Sponsors and collaborators
Lead sponsor
Novo Nordisk A/S
Industry
Registry information
Important dates
- Study start
- 2014
- Primary completion
- 2014
- Study completion
- 2014
- First posted
- Mar 24, 2014
- Registry last updated
- Jan 29, 2015
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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