Investigation on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NN9924 in Healthy Male Subjects

Healthy Clinical Trial

Official title:

Investigation on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of a Long-acting GLP-1 Analogue in Healthy Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01272973
• Other study ID #: NN9924-3692
• Secondary ID: U1111-1118-02572
• Status: Completed
• Phase: Phase 1
• First received: January 7, 2011
• Last updated: February 20, 2015
• Start date: January 2011
• Est. completion date: July 2011

Study information

• Verified date: February 2015
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medicinal Devices (BfarM)
• Study type: Interventional

Clinical Trial Summary

This trial is conducted in Europe. The aim of the trial is to investigate safety, tolerability, pharmacokinetics (the rate at which the body eliminates the trial drug) and pharmacodynamics (the effect of the investigated drug on the body) of NN9924 in healthy male subjects

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Healthy male subjects, based on an assessment of medical history, physical examination and

• BMI between 21 and 30 kg/m2 (21 inclusive)

Exclusion Criteria:

• Male subjects who are sexually active and unwilling to use a highly effective method of contraception for both them and their nonpregnant partner

• Any clinically significant, abnormal disease history of the following systems:

cardio-pulmonary, gastrointestinal, hepatic, neurological, renal,genitourinary, endocrine or haematological

• The receipt of any investigational product within 90 days before screening, or is currently enrolled in any other clinical trial

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Healthy

Intervention

Drug:
• semaglutide
Semaglutide (oral) administered once daily for 10 weeks.Individually adjusted dose investigated up to maximum level.
• placebo
Placebo (oral) administered once daily for 10 weeks.
• semaglutide
Administered s.c. (under the skin) once weekly for 10 weeks. Individually adjusted dose investigated up to maximum level.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of adverse events (AEs)		from the first trial related activity (screening visit) and until completion of the post treatment follow-up visit 91-105 days after first dose	No
Secondary	Hypoglycaemic episodes		from the first trial related activity (screening visit) and until completion of the post treatment follow-up visit 91-105 days after first dose	No
Secondary	Laboratory safety variables (haematology, biochemistry, and urinalysis)		from the first trial related activity (screening visit) and until completion of the post treatment follow-up visit 91-105 days after first dose	No
Secondary	Maximum plasma concentration of NN9924		after dosing on the 68th, 69th and 70th Day	No
Secondary	Area under the plasma concentration curve over the dosing interval (0-24 hours)		after dosing on the 68th, 69th and 70th day	No
Secondary	Terminal phase elimination half-life		from last dose (day 70) to follow-up visit 91-105 days after first dose	No

External Links

•   Clinical Trials at Novo Nordisk