Investigation on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of a Long Acting GLP-1 Analogue (NNC0113-0987) in Healthy Male Subjects

NCT ID: NCT01967589

Last Updated: 2014-06-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2014-05-31

Brief Summary

This trial is conducted in Europe. The aim of the trial is to investigate safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of multiple doses of a long acting GLP-1 analogue (NNC0113-0987) in healthy male subjects.

Conditions

Diabetes; Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

DC (dosing condition)

Escalation design.

Group Type: EXPERIMENTAL

NNC0113-0987

Intervention Type: DRUG

Once-daily doses for oral administration. Multiple doses with sequential dose increments over 10 weeks. Progression to next dose increment is based on a safety evaluation

placebo

Intervention Type: DRUG

Once-daily doses for oral administration

Oral A

Escalation design. Planned end-dose is 5 mg.

Group Type: EXPERIMENTAL

NNC0113-0987

Intervention Type: DRUG

Once-daily doses for oral administration. Multiple doses with sequential dose increments over 10 weeks. Progression to next dose increment is based on a safety evaluation

placebo

Intervention Type: DRUG

Once-daily doses for oral administration

Oral B

Escalation design. Planned end-dose is 10 mg.

Group Type: EXPERIMENTAL

NNC0113-0987

Intervention Type: DRUG

Once-daily doses for oral administration. Multiple doses with sequential dose increments over 10 weeks. Progression to next dose increment is based on a safety evaluation

placebo

Intervention Type: DRUG

Once-daily doses for oral administration

Oral C

Escalation design. Planned end-dose is 20 mg.

Group Type: EXPERIMENTAL

NNC0113-0987

Intervention Type: DRUG

Once-daily doses for oral administration. Multiple doses with sequential dose increments over 10 weeks. Progression to next dose increment is based on a safety evaluation

placebo

Intervention Type: DRUG

Once-daily doses for oral administration

Interventions

NNC0113-0987

Once-daily doses for oral administration. Multiple doses with sequential dose increments over 10 weeks. Progression to next dose increment is based on a safety evaluation

Intervention Type: DRUG

placebo

Once-daily doses for oral administration

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male, who is considered to be generally healthy, based on the medical history, physical examination and the results of vital signs, electrocardiogram (ECG) and laboratory safety tests performed during the screening visit, as judged by the investigator
• Age 18-64 years (both inclusive) at the time of signing informed consent
• BMI (body mass index) 20.0-29.9 kg/m^2 (both inclusive)

Exclusion Criteria

• History of, or presence of, cancer, diabetes or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal (GI), endocrinological, haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders, as judged by the investigator
• Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2
• History of chronic pancreatitis or idiopathic acute pancreatitis
• Use of prescription or non-prescription medicinal and herbal products (except routine vitamins) within three weeks preceding the dosing period. Occasional use of paracetamol or acetylsalicylic acid is permitted
• Subject with previous GI surgery, except subjects that underwent uncomplicated surgical procedures such as appendectomy, hernia surgery, biopsies, as well as colonic and gastric endoscopy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 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

2012-002893-30

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1131-8724

Identifier Type: OTHER

Identifier Source: secondary_id

NN9926-3950

Identifier Type: -

Identifier Source: org_study_id