None listed
Conditions
Interventions
Intervention1: Dr.Reddy’s darbepoetin alfa (DRL_DA): 60 mcg formulated for
Intravenous (IV) administration in a single-dose vial
Control Intervention1: Aranesp®: 60 mcg formulated for Intravenous (IV)
Sponsors
Dr Reddys Laboratories Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy Male volunteers, 18 to 50 years of age (both age inclusive) at the time of signing informed consent. 2. Body mass index between 18.5 - 30.0 kg/ m2 (both inclusive) and body weight of 55.0 – 95.0 kg (both inclusive). 3. In general good health as determined by a qualified physician based on a comprehensive medical history, physical examination including vital signs, laboratory hematology, clinical chemistry, urinalysis, and 12-lead electrocardiogram (ECG) before randomization. 4. Screening parameters (vital signs, physical examination, clinical laboratory tests, 12-lead ECG, thyroid function and coagulation parameters) within the normal range or outside the normal range but assessed as clinically non-significant by the Investigator (unless the value constitutes an explicit exclusion criterion). 5. Subjects or their female partner (if they are WOCBP) must be willing to use at least one highly effective method of contraception as described below from the time of first Investigational Medicinal Product (IMP) administration until 3 months after last dosing (Second period dosing). Highly effective birth control measures per CTFG (Clinical Trials Facilitation and Coordination Group) guidelines 2014 include the following: For Subject: 5.1 Permanently sterile by bilateral orchidectomy 5.2 Sexual abstinence For female partner of male Subject 5.3 Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation - oral, intravaginal, and transdermal; 5.4 Progestogen-only hormonal contraception associated with inhibition of ovulation - oral, injectable, implantable; 5.5 Intrauterine device; 5.6 Intrauterine hormone-releasing system; 5.7 Bilateral tubal occlusion; 5.8 Vasectomized partner; 5.9 Sexual abstinence 6. Capable, and amenable to providing written informed consent to the study requirements. 7. Willing to stay on study restrictions for 16 weeks and abide by the study processes during the follow up period if and as applicable.
Exclusion criteria
Exclusion criteria: 1. Positive test result for syphilis, hepatitis B, hepatitis C, or HIV-1 or -2. 2. Any prior exposure to darbepoetin or to any other erythropoiesis stimulating agent including investigational products [example: Epogen® (epoetin alfa) and its biosimilar/s]. 3. Allergy or hypersensitivity to any recombinant human or humanized antibodies, other therapeutic proteins, or any excipients in the study formulations as well as latex allergy. 4. Hemoglobin concentration higher than “ULN - 0.5 gm/dl ?; reticulocyte percent >3% serum ferritin Note: “ULN – 0.5 gm/dl ?: Upper Limit of Normal reference range of the study site for haemoglobin subtracted with 0.5 gm/dl 5. Known history or presence of hemoglobinopathies including but not limited to sickle cell disease or trait and thalassemias. If suspecting any, to be ruled out by appropriate tests. 6. History and/ or current presence of clinically significant (in the opinion of the Investigator) atopic allergy (e.g., asthma including childhood asthma, urticaria, angioedema, eczematous dermatitis), hypersensitivity or allergic reactions or any history or presence of vasculitis or psoriasis. 7. Blood donation, participation in any study requiring repeated blood sampling or hemorrhage requiring treatment or any transfusion in the past 3 months. 8. Screening or baseline blood pressure higher than 140 mm Hg (systolic) or higher than 90 mm Hg (diastolic) or volunteers currently on anti-hypertensive drugs. Note: Up to two repeats in different days are allowed (repeats on the same visit can be done if white coat hypertension is suspected) and, in this case, the mean of the measurements will be used to decide on eligibility. Blood pressure is to be measured in the sitting position after 5 minutes rest on the same position. 9. History of relevant (in the Opinion of the Investigator) orthostatic hypotension, fainting spells, or blackouts as well as history of difficulties with blood sampling which potentially may interfere with the study objectives, as per the opinion of the Investigator. 10. QTc (Fridericia correction) longer than 450 milliseconds or other ECG abnormalities such as atrial fibrillation, atrial flutter, Wolf-Parkinson-White syndrome, or presence of a cardiac pacemaker or any other ECG abnormality considered clinically relevant by the Investigator. 11. History or presence of any clinically relevant nervous system disease including, but not restricted to any stroke/TIA or of seizures other than febrile seizures before the age of 5 years. 12. History of and/or current gastrointestinal, neurological, renal, endocrine, pulmonary, hepatic, cardiovascular (including history of or presence of angina, exertional dyspnea, orthopnea, congestive heart failure or myocardial infarction and thrombotic or embolic episode requiring treatment), hematological [including pancytopenia, aplastic anemia, or blood dyscrasia and coagulopathies or an International Normalized Ratio (INR) higher than 1.5] or metabolic (including known diabetes mellitus) disease. This criterion also includes any disorder or condition that, in the Investigator’s opinion, may interfere with the safety of the subject, the study evaluations o
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters (calculated by standard non-compartmental methods on actual sampling times): AUC0-t and AUC0-8Timepoint: period 2 day 42 of study | — |
Secondary
| Measure | Time frame |
|---|---|
| •Pharmacokinetic parameters: Cmax, tmax, apparent terminal decline rate constant ?z (also known as apparent terminal elimination rate constant kel), t1/2, CL and Vss; %AUCext will be reported to evaluate the coverage of AUC by the sampling schedule but is not considered a pharmacokinetic endpoint. •Pharmacodynamic parameters: Emax and AUEC of reticulocyte count and percentage •Safety and tolerability of the treatments •Comparative incidence of anti-Darbepoetin antibodiesTimepoint: period 2 day 42 of study | — |
Countries
India
Contacts
Public ContactDr Anand Eswaraiah
Dr. Reddy’s Laboratories Ltd
Outcome results
None listed