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

NCT ID: NCT02094521

Last Updated: 2015-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 122 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2014-07-31

Brief Summary

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.

Conditions

Diabetes; Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

NNC0113-0987

Group Type: EXPERIMENTAL

NNC0113-0987

Intervention Type: DRUG

For 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.

Interventions

NNC0113-0987

For 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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Harrow, , United Kingdom

Countries

United Kingdom

Related Links

http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

2012-003855-13

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1133-7097

Identifier Type: OTHER

Identifier Source: secondary_id

NN9926-4047

Identifier Type: -

Identifier Source: org_study_id