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

NCT01272973 | Completed Phase 1

• 3 other identifiers: NN9924-3692U1111-1118-02572010-019951-23
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Diabetes; Diabetes Mellitus, Type 2; Healthy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• 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

• 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

• Maximum plasma concentration of NN9924

  after dosing on the 68th, 69th and 70th Day

• Area under the plasma concentration curve over the dosing interval (0-24 hours)

  after dosing on the 68th, 69th and 70th day

• Terminal phase elimination half-life

  from last dose (day 70) to follow-up visit 91-105 days after first dose

Study Arms (4)

Oral 1

EXPERIMENTAL

Drug: semaglutide; Drug: placebo

Oral 2

EXPERIMENTAL

Drug: semaglutide; Drug: placebo

Oral 3

EXPERIMENTAL

Drug: semaglutide; Drug: placebo

S.c.

ACTIVE COMPARATOR

Drug: semaglutide

Interventions

semaglutide DRUG

Semaglutide (oral) administered once daily for 10 weeks.Individually adjusted dose investigated up to maximum level.

Oral 1; Oral 2; Oral 3

placebo DRUG

Placebo (oral) administered once daily for 10 weeks.

Oral 1; Oral 2; Oral 3

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male subjects, based on an assessment of medical history, physical examination and
• BMI between 21 and 30 kg/m2 (21 inclusive)

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Unknown Facility

Berlin, 14050, Germany

Location

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2011
• First Posted: January 10, 2011
• Study Start: January 1, 2011
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: February 23, 2015

Record last verified: 2015-02

Locations

DE (1)