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

Phase 1

Completed

• Conditions: Diabetes; Healthy
• Interventions: Drug: NNC0113-0987

• Registration Number: NCT02094521
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-03-20
• Study First Submitted QC: 2014-03-20
• Study First Posted: 2014-03-24
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-28
• Last Update Posted: 2015-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 122

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NNC0113-0987	NNC0113-0987	-

Primary Outcome Measures

Name	Time	Method
Area under the NNC0113-0987 plasma concentration time curve	From time 0 to 24 hours after the 10th dosing

Secondary Outcome Measures

Name	Time	Method
Maximum observed NNC0113-0987 plasma concentration	0 to 24 hours after the 10th dosing