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

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Healthy; Diabetes

Treatments: Drug: placebo; Drug: NNC0113-0987

Study type: Interventional

Funder types: Industry

Identifiers

NCT01967589

U1111-1131-8724 (Other Identifier)

NN9926-3950

2012-002893-30 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 82 patients

Sex: Male

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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82 participants in 4 patient groups

DC (dosing condition)

Experimental group

Description:

Escalation design.

Treatment:

Drug: placebo

Drug: NNC0113-0987

Oral A

Experimental group

Description:

Escalation design. Planned end-dose is 5 mg.

Treatment:

Drug: placebo

Drug: NNC0113-0987

Oral B

Experimental group

Description:

Escalation design. Planned end-dose is 10 mg.

Treatment:

Drug: placebo

Drug: NNC0113-0987

Oral C

Experimental group

Description:

Escalation design. Planned end-dose is 20 mg.

Treatment:

Drug: placebo

Drug: NNC0113-0987