Investigation on Safety, Tolerability and Pharmacokinetics of Multiple Doses of NNC0113-0987 in an Oral Formulation in Healthy Subjects

NCT ID: NCT01978613

Last Updated: 2014-06-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2014-06-30

Brief Summary

This trial is conducted in Europe. The aim of the trial is to investigate safety, tolerability and pharmacokinetics (the exposure of the trial drug in the body) of multiple doses of NNC0113-0987 in an oral formulation in healthy subjects.

Conditions

Diabetes; Healthy

Study Design

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

Study Groups

Oral B (DC)

Escalation design. Planned end dose level is 5 mg alternative dosing condition (fasting for 30 minutes post-dosing)

Group Type: EXPERIMENTAL

NNC0113-0987

Intervention Type: DRUG

Tablets for once-daily oral administration. Multiple doses with sequential dose increments over 10 weeks. The end-dose levels and the dose levels during the escalation regime may be adapted during trial conduct based on safety evaluations.

placebo

Intervention Type: DRUG

Tablets for one-daily oral administration.

Oral D

Escalation design. Planned end dose level is 20 mg standard dosing condition (fasting for 120 minutes post-dosing)

Group Type: EXPERIMENTAL

NNC0113-0987

Intervention Type: DRUG

Tablets for once-daily oral administration. Multiple doses with sequential dose increments over 10 weeks. The end-dose levels and the dose levels during the escalation regime may be adapted during trial conduct based on safety evaluations.

placebo

Intervention Type: DRUG

Tablets for one-daily oral administration.

Oral C

Escalation design. Planned end dose level is 10 mg standard dosing condition (fasting for 120 minutes post-dosing)

Group Type: EXPERIMENTAL

NNC0113-0987

Intervention Type: DRUG

Tablets for once-daily oral administration. Multiple doses with sequential dose increments over 10 weeks. The end-dose levels and the dose levels during the escalation regime may be adapted during trial conduct based on safety evaluations.

placebo

Intervention Type: DRUG

Tablets for one-daily oral administration.

Oral B

Escalation design. Planned end dose level is 5 mg standard dosing condition (fasting for 120 minutes post-dosing)

Group Type: EXPERIMENTAL

NNC0113-0987

Intervention Type: DRUG

Tablets for once-daily oral administration. Multiple doses with sequential dose increments over 10 weeks. The end-dose levels and the dose levels during the escalation regime may be adapted during trial conduct based on safety evaluations.

placebo

Intervention Type: DRUG

Tablets for one-daily oral administration.

Oral A

Escalation design. Planned end dose level is 2.5 mg standard dosing condition (fasting for 120 minutes post-dosing)

Group Type: EXPERIMENTAL

NNC0113-0987

Intervention Type: DRUG

Tablets for once-daily oral administration. Multiple doses with sequential dose increments over 10 weeks. The end-dose levels and the dose levels during the escalation regime may be adapted during trial conduct based on safety evaluations.

placebo

Intervention Type: DRUG

Tablets for one-daily oral administration.

Interventions

NNC0113-0987

Tablets for once-daily oral administration. Multiple doses with sequential dose increments over 10 weeks. The end-dose levels and the dose levels during the escalation regime may be adapted during trial conduct based on safety evaluations.

Intervention Type: DRUG

placebo

Tablets for one-daily oral administration.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male subject, who is considered to be generally healthy, based on the medical history, physical examination, and the results of vital signs, electrocardiogram 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
• Body mass index (BMI): 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, 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 syndrome type 2
• History of chronic pancreatitis or idiopathic acute pancreatitis
• Subject with previous gastrointestinal surgery, except subjects that underwent uncomplicated surgical procedures such as appendectomy, hernia surgery, biopsies, as well as colonic and gastric endoscopy
• Use of prescription or non-prescription medicinal products and herbal products (except routine vitamins) within three weeks preceding the dosing period. Occasional use of paracetamol or acetylsalicylic acid is permitted

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

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

Berlin, , Germany

Countries

Germany

Related Links

http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

2013-000188-10

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1138-4595

Identifier Type: OTHER

Identifier Source: secondary_id

NN9927-4022

Identifier Type: -

Identifier Source: org_study_id