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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02094521
• Other study ID #: NN9926-4047
• Secondary ID: 2012-003855-13U1
• Status: Completed
• Phase: Phase 1
• First received: March 20, 2014
• Last updated: January 28, 2015
• Start date: March 2014
• Est. completion date: July 2014

Study information

• Verified date: January 2015
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Healthy

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the NNC0113-0987 plasma concentration time curve		From time 0 to 24 hours after the 10th dosing	No
Secondary	Maximum observed NNC0113-0987 plasma concentration		0 to 24 hours after the 10th dosing	No

External Links

•   Clinical Trials at Novo Nordisk