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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Harrow, United Kingdom, HA1 3UJ

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DC (dosing condition); Escalation design.	Drug: 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; Drug: placebo; Once-daily doses for oral administration
Experimental: Oral A; Escalation design. Planned end-dose is 5 mg.	Drug: 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; Drug: placebo; Once-daily doses for oral administration
Experimental: Oral B; Escalation design. Planned end-dose is 10 mg.	Drug: 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; Drug: placebo; Once-daily doses for oral administration
Experimental: Oral C; Escalation design. Planned end-dose is 20 mg.	Drug: 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; Drug: placebo; Once-daily doses for oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of treatment emergent adverse events (TEAEs) 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
Area under the NNC0113-0987 plasma concentration 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)
Time to maximum observed NNC0113-0987 plasma concentration	During a dosing interval (0-24 hours) at steady state (Day 67; Day 68 and Day 69)
Change in fasting plasma glucose (FPG)	From baseline (Day 0, pre-dose) to after 10 weeks of treatment (Day 70)
Change in HbA1C (glycosylated haemoglobin)	From baseline (Day 0, pre-dose) to after 10 weeks of treatment (Day 70)
Change in body weight	From baseline (Day -1) to after 10 weeks of treatment (Day 70)

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: October 1, 2013
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: October 18, 2013
• First Submitted That Met QC Criteria: October 18, 2013
• First Posted (Estimate): October 23, 2013

Study Record Updates

• Last Update Posted (Estimate): June 20, 2014
• Last Update Submitted That Met QC Criteria: June 19, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: NN9926-3950; 2012-002893-30 (EudraCT Number); U1111-1131-8724 (Other Identifier: WHO)