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

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.

Study Overview

• Status: Completed
• Conditions: Healthy; Diabetes
• Intervention / Treatment: Drug: NNC0113-0987; Drug: placebo

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 14050

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oral B (DC); Escalation design. Planned end dose level is 5 mg alternative dosing condition (fasting for 30 minutes post-dosing)	Drug: 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.; Drug: placebo; Tablets for one-daily oral administration.
Experimental: Oral D; Escalation design. Planned end dose level is 20 mg standard dosing condition (fasting for 120 minutes post-dosing)	Drug: 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.; Drug: placebo; Tablets for one-daily oral administration.
Experimental: Oral C; Escalation design. Planned end dose level is 10 mg standard dosing condition (fasting for 120 minutes post-dosing)	Drug: 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.; Drug: placebo; Tablets for one-daily oral administration.
Experimental: Oral B; Escalation design. Planned end dose level is 5 mg standard dosing condition (fasting for 120 minutes post-dosing)	Drug: 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.; Drug: placebo; Tablets for one-daily oral administration.
Experimental: Oral A; Escalation design. Planned end dose level is 2.5 mg standard dosing condition (fasting for 120 minutes post-dosing)	Drug: 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.; Drug: placebo; Tablets for one-daily oral administration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of treatment emergent adverse events recorded	From the time of first dosing (day 0) and until completion of the post-treatment follow-up visit (day 83-97)

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of hypoglycaemic episodes	From the time of first dosing (day 0) and until completion of the post-treatment follow-up visit (day 83-97)
Area under the NNC0113-0987 plasma concentration time curve	During a dosing interval (0-24 hours) at steady state (day 67, day 68 and day 69)
Maximum observed NNC0113-0987 plasma concentration	During a dosing interval (0-24 hours) at steady state (day 67, day 68 and day 69)

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S

Publications and helpful links

Helpful Links

• Clinical Trials at Novo Nordisk

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: November 1, 2013
• First Submitted That Met QC Criteria: November 1, 2013
• First Posted (Estimate): November 7, 2013

Study Record Updates

• Last Update Posted (Estimate): June 30, 2014
• Last Update Submitted That Met QC Criteria: June 27, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: NN9927-4022; 2013-000188-10 (EudraCT Number); U1111-1138-4595 (Other Identifier: WHO)