Dose Study in Healthy Japanese Males Investigating Safety, Pharmacokinetics and Pharmacodynamics of NNC126-0083

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Healthy; Growth Hormone Disorder

Treatments: Drug: NNC126-0083; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00722540

NN8630-1958

2008-001578-33 (EudraCT Number)

Details and patient eligibility

About

This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of a NNC126-0083 in healthy male Japanese subjects.

Enrollment: 40 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male subjects with Japanese passport and Japanese born parents
• Body Mass Index (BMI, kg/m2) between 18.0 and 27.0, both inclusive
• Subjects must be in good health according to age

Exclusion criteria

• A history 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 diseases
• History of any illnesses or disease that, in the opinion of the Investigator might confound the results of the trial or pose additional risk in administering the trial product to the subject
• Any clinically significant abnormal haematology, biochemistry or urinalysis screening tests, as judged by the Investigator

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 5 patient groups

A

Experimental group

Treatment:

Drug: placebo

Drug: NNC126-0083

Drug: NNC126-0083

Drug: NNC126-0083

Drug: placebo

Drug: placebo

Drug: NNC126-0083

Drug: placebo

Drug: NNC126-0083

Drug: placebo

B

Experimental group

Treatment:

Drug: placebo

Drug: NNC126-0083

Drug: NNC126-0083

Drug: NNC126-0083

Drug: placebo

Drug: placebo

Drug: NNC126-0083

Drug: placebo

Drug: NNC126-0083

Drug: placebo

C

Experimental group

Treatment:

Drug: placebo

Drug: NNC126-0083

Drug: NNC126-0083

Drug: NNC126-0083

Drug: placebo

Drug: placebo

Drug: NNC126-0083

Drug: placebo

Drug: NNC126-0083

Drug: placebo

D

Experimental group

Treatment:

Drug: placebo

Drug: NNC126-0083

Drug: NNC126-0083

Drug: NNC126-0083

Drug: placebo

Drug: placebo

Drug: NNC126-0083

Drug: placebo

Drug: NNC126-0083

Drug: placebo

E

Experimental group

Treatment:

Drug: placebo

Drug: NNC126-0083

Drug: NNC126-0083

Drug: NNC126-0083

Drug: placebo

Drug: placebo

Drug: NNC126-0083

Drug: placebo

Drug: NNC126-0083

Drug: placebo