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

Phase 1

Completed

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

• Registration Number: NCT01978613
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-11-01
• Study First Submitted QC: 2013-11-01
• Study First Posted: 2013-11-07
• Status Verified: 2014-06
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Last Update Submitted: 2014-06-27
• Last Update Posted: 2014-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 100

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)

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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
• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral B (DC)	NNC0113-0987	Escalation design. Planned end dose level is 5 mg alternative dosing condition (fasting for 30 minutes post-dosing)
Oral B (DC)	placebo	Escalation design. Planned end dose level is 5 mg alternative dosing condition (fasting for 30 minutes post-dosing)
Oral D	NNC0113-0987	Escalation design. Planned end dose level is 20 mg standard dosing condition (fasting for 120 minutes post-dosing)
Oral D	placebo	Escalation design. Planned end dose level is 20 mg standard dosing condition (fasting for 120 minutes post-dosing)
Oral C	NNC0113-0987	Escalation design. Planned end dose level is 10 mg standard dosing condition (fasting for 120 minutes post-dosing)
Oral C	placebo	Escalation design. Planned end dose level is 10 mg standard dosing condition (fasting for 120 minutes post-dosing)
Oral B	NNC0113-0987	Escalation design. Planned end dose level is 5 mg standard dosing condition (fasting for 120 minutes post-dosing)
Oral A	NNC0113-0987	Escalation design. Planned end dose level is 2.5 mg standard dosing condition (fasting for 120 minutes post-dosing)
Oral A	placebo	Escalation design. Planned end dose level is 2.5 mg standard dosing condition (fasting for 120 minutes post-dosing)
Oral B	placebo	Escalation design. Planned end dose level is 5 mg standard dosing condition (fasting for 120 minutes post-dosing)

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)