Evaluation of Optimal Dosing Conditions for GLP-1 Analogue NNC0113-0987 When Administered Orally in Healthy Male Subjects

Novo Nordisk

Status and phase

Completed

Phase 1

Conditions

Healthy

Diabetes

Treatments

Drug: NNC0113-0987

Study type

Interventional

Funder types

Industry

Identifiers

NCT02094521

NN9926-4047

2012-003855-13 (EudraCT Number)

U1111-1133-7097 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

122 patients

Sex

Male

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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