NCT02053753已完成1 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 146
- 试验地点
- 1
- 主要终点
- Maximum Observed Drug Concentration (Cmax) of Denosumab
研究概览
简要总结
To evaluate the bioequivalence based on pharmacokinetics (PK) of a single 120 mg subcutaneous dose of denosumab administered to healthy volunteers using denosumab CP4 or denosumab CP2 drug products.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •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 -
- •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
研究组 & 干预措施
Drug Product CP4
Experimental
Participants received a single dose of 120 mg denosumab manufactured using the new CP4 process subcutaneously on day 1.
干预措施: Denosumab CP4 (Drug)
Drug Product CP2
Experimental
Participants received a single dose of 120 mg denosumab manufactured using the current CP2 process subcutaneously on day 1.
干预措施: Denosumab CP2 (Drug)
结局指标
主要结局
Maximum Observed Drug Concentration (Cmax) of Denosumab
时间窗: Day 1 predose up to day 127
Serum denosumab concentration-time data were analyzed by non-compartmental methods. Serum concentrations below the LLOQ (20.0 ng/mL) were set to 0 before data analysis.
Area Under the Drug Concentration-time Curve From Time 0 to 18 Weeks Post-dose (AUC0-18 Weeks) of Denosumab
时间窗: Day 1 predose up to day 127
Serum denosumab concentration-time data were analyzed by non-compartmental methods. Serum concentrations below the LLOQ (20.0 ng/mL) were set to 0 before data analysis.
次要结局
- Time to Maximum Observed Concentration (Tmax) of Denosumab(Day 1 predose up to day 127)
- Half-life (T1/2) of Denosumab(Day 1 predose up to day 127)
- Area Under the Serum C-telopeptide (CTX1) Percent Inhibition-Time Curve From Time 0 to 18 Weeks Post-dose (AUEC0-18 Weeks)(Day 1 predose up to day 127)
- Maximum Percent Inhibition (Imax) of Serum CTX1(Day 1 predose up to day 127)
- Time to Reach Maximum Percent Inhibition (Tmax) of Serum CTX1(Day 1 predose up to day 127)
- Number of Participants With Adverse Events(From the first dose of denosumab through day 126)
- Number of Participants Who Developed Anti-denosumab Antibodies(Predose on day 1, and days 29, 67 and 127)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Study of Darunavir in the Presence of Cobicistat When Administered as a Fixed Dose Combination Under Fed ConditionsHealthyNCT04718805Janssen Research & Development, LLC22
已完成
1 期
A Study of Darunavir in the Presence of Cobicistat When Administered as a Fixed Dose Combination Compared to the Co-administration of the Separate Available Formulations of Darunavir and Cobicistat Under Fed Conditions in Healthy ParticipantsHealthyNCT05378906Janssen Research & Development, LLC32
已完成
1 期
A Study of Macitentan and Tadalafil as a Fixed Dose Combination and the Free Combination in Healthy Adult ParticipantsHealthyNCT04235270Janssen Research & Development, LLC62
已完成
1 期
A Study of Fixed Dose Combination of Macitentan/Tadalafil (10 mg/20 mg) Compared to the Reference Free Combination of Macitentan and Tadalafil in Healthy Adult ParticipantsHealthyNCT05236231Actelion40
已完成
1 期
Bioequivalence Study of Torrent Pharmaceuticals Ltd's Bioequivalence Study of Torrent Pharmaceuticals Ltd's Quetiapine Tablets Under Fed ConditionsHealthyNCT01634399Torrent Pharmaceuticals Limited