Clinical pharmacology study of repeated intramuscular injections of G-CSF

Not Applicable

• Conditions: ot applicable

• Registration Number: JPRN-UMIN000020971
• Lead Sponsor: Department of Orthopaedic Surgery, Keio University School of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-02-12
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

1) Those who are physically and mentally sound.
2) 20-39 years of age at the time of consent.
3) Those who can be hospitalized from Day -1 of the study.
4) Those who have agreed on the written informed consent.
5) Those who are capable to comply with all study procedures and restrictions.
6) Body weight; 50-80 kg and Body mass index (BMI); 18.5-25.0 kg/m2 at the screening examination.
7) Systolic blood pressure ; 90 mmHg to 140 mmHg and diastolic blood pressure; <90mmHg (sitting position) at the screening examination.
8) WBC 3,300-8,000/microL before the injection of the agent.

Exclusion Criteria

1) Those who are potentially pregnant.
2) Those who have a history of serious illnesses, or are under treatment for such illnesses.
3) Those who have a history of drug allergies.
4) Those who have a history of allergy to recombinant G-CSF agents.
5) Those who have a history of excessive alcohol abuse.
6) Smokers of cigarettes.
7) Those who had participated in an investigational drug study within the past 4 months.
8) Those who had used medicine within the past week.
9) Those who had a blood donation as follows; >200ml within the past 1 week, >400ml within the past 12 weeks, or >800ml within the past year.
10) Those who are positive for hepatitis B, hepatitis C, syphilis or HIV.
11) Those who are determined by the principle investigator inadequate as participants for the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the linearity and cumulative effects of repeated intramuscular G-CSF injections based on the PK parameters<br><br>Primary PK parameters: Cmax and AUC0-24 (Day1 and Day3)<br><br>Safety: Adverse events and adverse drug reactions (symptoms, objective findings, clinical examinations (hematology, biochemistry), vital signs, electrocardiogram)

Secondary Outcome Measures

Name	Time	Method
Secondary PK parameters: AUC 0 to Infinity, tmax(Day1 and Day3), MRT(Day1), kel(Day1 and Day3) and t1/2(Day1 and Day3)