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A Double-Blind, Randomized, Single-Dose, Parallel-Group Study in Healthy Volunteers to Assess the Bioequivalence of a 120 mg Denosumab Subcutaneous Dose When Administered as Denosumab CP4 Drug Product or as Commercially Available Denosumab CP2 Drug Product

Information source: Amgen
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy Volunteer

Intervention: Drug Product CP4 (Drug); Drug Product CP2 (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Amgen

Official(s) and/or principal investigator(s):
MD, Study Director, Affiliation: Amgen

Summary

Approximately 140 male and female healthy subjects will be randomized (1: 1 ratio) to receive a 120 mg single dose of denosumab either as a 1. 7 mL single injection of 70 mg/mL denosumab CP4 (Treatment A) or as a 1. 7 mL single injection of 70 mg/mL denosumab CP2 (Treatment B).

Subjects will be admitted to the research facility on day - 1 and remain in the research

facility through day 2. The subjects will return to the research facility on an outpatient basis. The PK, PD, and safety assessments will be conducted during the inpatient stay and at regular intervals during the 18-week treatment period.

Clinical Details

Official title: A Double-Blind, Randomized, Single-Dose, Parallel-Group Study in Healthy Volunteers to Assess the Bioequivalence of a 120 mg Denosumab Subcutaneous Dose When Administered as Denosumab CP4 Drug Product or as Commercially Available Denosumab CP2 Drug Product

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Primary outcome: PK parameters AUC0-18 weeks and Cmax

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Key Inclusion:

- Healthy male and female, ages ≥ 18 to ≤ 65 years (inclusive)

- Body weight > 60 to < 100 kg at time of screening

- Clinically acceptable physical exams and laboratory tests (blood hematology, blood

chemistry, urinalysis) and no history or evidence of any clinically significant medical disorder that would pose a risk to subject safety or interfere with study evaluations or procedures

- Normal or clinically acceptable electrocardiogram (ECG) (12-lead reporting heart rate

and PR, QRS, QT, and QTc intervals) at screening

- Willing to be confined to the research facility for 2 consecutive nights

- Subject will be available for follow-up assessments

Exclusion Criteria: Prior diagnosis of bone disease, or any condition that will affect bone metabolism such as, but not limited to: osteoporosis, osteogenesis imperfecta, hyperparathyroidism, hyperthyroidism, hypothyroidism, osteomalacia, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, current flare-up of osteoarthritis and/or gout, active malignancy, renal disease (defined as glomerular filtration rate [GFR] < 45 mL/min), Paget's disease of the bone, recent bone fracture (within 6 months), malabsorption syndrome

- Presents with any psychiatric disorder, which may prevent the subject from completing

the study or interfere with the interpretation of the study results

- Significant changes in physical activity during the 6 months before study drug

administration or constant levels of intense physical exercise

- Prior use of any non-Amgen approved medications within 4 weeks or 5-half lives

(whichever time period is longer) of study drug administration and for the duration of the study. This includes medications such as, but not limited to: bisphosphonates, fluoride, hormone replacement therapy (ie, estrogen) or selective estrogen receptor modulator, such as ralaxofene, calcitonin, strontium, parathyroid hormone or derivatives, supplemental vitamin D [>1000 IU/day], glucocorticosteroids, anabolic steroids, calcitriol, diuretics, over the counter medications, herbal supplements

- Positive for human immunodeficiency virus (HIV) at screening or known diagnosis of

acquired immune deficiency syndrome (AIDS)

- Positive hepatitis B surface antigen (HepBsAg) (indicative of chronic hepatitis B) or

detectable hepatitis C virus ribonucleic acid (RNA) by polymerase chain reaction

(PCR) at screening (indicative of active hepatitis C - screening is generally done by

hepatitis C antibody [HepCAb], followed by hepatitis C virus RNA by PCR if HepCAb is positive)

- Known sensitivity to any of the products to be administered during the study

- Prior denosumab administration

- Receiving or has received any investigational drug (or is currently using an

investigational device) within 30 days before receiving study drug, or at least 10 times the respective elimination half-life (whichever period is longer) and for the duration of the study

- Women with a positive pregnancy test at screening or day-1

- Men and women of reproductive potential who are unwilling to practice a highly

effective method of birth control while on study through 5 months after receiving the last dose of study drug. Highly effective methods of birth control include sexual abstinence (men, women); vasectomy; or a condom with spermicide (men) in combination with either barrier methods, hormonal birth control or intrauterine device (women)

- Women who are lactating/breastfeeding or who plan to breastfeed while on study

through 5 half-lives after receiving the dose of study drug

- Women planning to become pregnant while on study through 5 months after receiving the

dose of study drug

- Men with partners who are pregnant or planning to become pregnant while the subject

is on study through 5 months after receiving the last dose of study drug

- Unwilling or unable to limit alcohol consumption throughout the course of the study.

Alcohol is prohibited 24 hours prior to screening, 24 hours prior to check-in on day

- 1, and throughout confinement. Alcohol is also limited to no more than 2 drinks per

day during the outpatient period of the study through completion of day 127 (EOS). A standard drink is equivalent to 12 ounces of regular beer, 8 to 9 ounces of malt liquor, 5 ounces of wine, or 1. 5 ounces of 80 proof distilled spirits

- Positive urine screen for alcohol and/or drugs with a high potential for abuse at

screening or day - 1. Rescreening of the subject within 48 hours of a positive result

is permitted

- Any other condition that might reduce the chance of obtaining data required by

protocol or that might compromise the ability to give truly informed consent and/or comply with study procedures

- Osteonecrosis of the jaw (ONJ) or risk factors for ONJ such as invasive dental

procedures (eg, tooth extraction, dental implants, oral surgery in the past 6 months), poor oral hygiene, periodontal, and/or pre-existing dental disease

- Recent tooth extraction (within 6 months of screening visit)

- Evidence of hypocalcemia at screening

- Known vitamin D deficiency

- Known intolerance to calcium or vitamin D supplements

Locations and Contacts

Research Site, Cypress, California 90630, United States

Research Site, San Antonio, Texas 78209, United States

Additional Information

AmgenTrials clinical trials website

Starting date: February 2014
Last updated: April 8, 2015

Page last updated: August 23, 2015

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