A PILOT PHASE 1, REPEATED SINGLE DOSE STUDY EVALUATING THE VARIABILITY OF PHARMACOKINETICS AND PHARMACODYNAMICS OF LONG ACTING FILGRASTIM FOLLOWING SUBCUTANEOUS ADMINISTRATION TO HEALTHY VOLUNTEERS

Completed

• Conditions: Neutropenia; 10047954

• Registration Number: NL-OMON37064
• Lead Sponsor: Mylan GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 24

Inclusion Criteria

1. Willingness and able to provide Informed Consent ;2. Gender : male or female;3. Age : 18 - 65 years, inclusive;4. Weight : minimal 60 kg;5. BMI : 19.0 - 30.0 kg/m2, inclusive [Body Mass Index (BMI) (kg/m2) <= Body weight (kg) / Height2 (m2)] ;6. Vital signs showing no clinically relevant deviations ;7. Computerised (12-lead) electrocardiogram (ECG) recording without signs of clinically relevant pathology;8. Nonsmoker or light smoker, i.e. smokes maximal 5 cigarettes per day; and ability and willingness to refrain from smoking from 24 hours prior to dosing and on Day 1 of each period, and to limit smoking from Day 2 onwards up to 5 cigarettes per day. ;9. Ability and willingness to abstain from alcohol from 48h prior to study drug administration and prior to ambulatory visits, and during the stays in the clinic until discharge;10. Willingness to use adequate (e.g. double barrier) contraception from screening until 90 days after the follow-up visit, or being surgically sterile for at least 6 months, or (for females) at least 1 year postmenopausal (amenorrhoea duration of at least 12 months);11. Females must not lactate and have a negative pregnancy test at screening and each admission;12. Differentiation of leukocytes, platelet count, haematocrit and haemoglobin results within the reference ranges ;13. All other values for haematology and for clinical chemistry tests of blood and urine within the normal range or showing no clinically relevant deviations as judged by the Medical Investigator

Exclusion Criteria

1. Mental handicap;2. Any past or concurrent medical conditions potentially increasing the subject*s risks. Examples of these include medical history with evidence of clinically relevant pathology (e.g. sickle cell disease, spleen pathologies, hematologic malignancies, and pulmonary illnesses such as Acute Respiratory Distress Syndrome (ARDS), interstitial pneumonia, pulmonary oedema, pulmonary infiltrates and pulmonary fibrosis) History of relevant drug and/or food allergies;3. Hypersensitivity to Neulasta® or its constituents (sorbitol E420 and sodium acetate) and/or hypersensitivity to E. coli derived proteins and/or history of previous exposure to PEG-GCSF;4. Subjects with any infections, cough or fever within 1 week prior to study drug administration ;5. Fructose intolerance;6. First grade relatives with haematological malignancy;7. Treatment with non-topical medications (including over the counter medication, and herbal remedies such as St. John*s Wort extract) within 7 days prior to study drug administration, with the exception of hormonal contraceptives, multivitamins, vitamin C, food supplements and a limited amount of acetaminophen, which may be used throughout the study. ;8. Participation in a drug study within 12 weeks prior to study drug administration. ;9. Donation of more than 50 mL of blood within 12 weeks prior to study drug administration. Donation of more than 1.5 litres of blood (for men) / more than 1.0 litres of blood (for women) in the 10 months preceding the start of this study.;10. History of alcohol abuse or drug addiction (including soft drugs like cannabis products);11. Regular intake of more than 24 units of alcohol per week (one unit of alcohol equals approximately 250 mL of beer, 100 mL of wine or 35 mL of spirits);12. Positive drug screen (opiates, methadone, cocaine, amphetamines, cannabinoids, barbiturates, benzodiazepines, tricyclic antidepressants and alcohol);13. Positive screen on Hepatitis B surface antigen (HBsAg), anti-Hepatitis C virus antibodies (HCV), or anti-human immunodeficiency virus 1/2 antibodies (HIV)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Pharmacokinetics / Pharmacodynamiek and safety, adverse events, laboratory<br /><br>data, vital signs, ECG and physical examination</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>PK: AUC0-inf, Cmax, Tmax, kel and half waardetijd.<br /><br><br /><br>PD: (AUC), (Tmax), (CD34+ Cmax). </p><br>