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

Phase 1

Completed

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

• Registration Number: NCT01967589
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-10-18
• Study First Submitted QC: 2013-10-18
• Study First Posted: 2013-10-23
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-19
• Last Update Posted: 2014-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 82

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral A	placebo	Escalation design. Planned end-dose is 5 mg.
DC (dosing condition)	NNC0113-0987	Escalation design.
DC (dosing condition)	placebo	Escalation design.
Oral A	NNC0113-0987	Escalation design. Planned end-dose is 5 mg.
Oral B	NNC0113-0987	Escalation design. Planned end-dose is 10 mg.
Oral B	placebo	Escalation design. Planned end-dose is 10 mg.
Oral C	NNC0113-0987	Escalation design. Planned end-dose is 20 mg.
Oral C	placebo	Escalation design. Planned end-dose is 20 mg.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)
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)
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)
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)