Comparing the Extent to Which Romosozumab (AMG 785) is Made Available in the Body When Administered as a Single SC Injection or as 2 SC Injections
A Phase 1, Open-label, Randomized, Parallel Group Study to Evaluate the Relative Bioavailability of Romosozumab (AMG 785) 210 mg Administered as a Single SC Injection or 2 SC Injections in Healthy Participants
The primary objective of this trial is to evaluate the relative bioavailability of romosozumab administered as a single 2.34 mL subcutaneous (SC) injection from a prefilled syringe (PFS) or 2 x 1.17 mL SC injections from PFS in healthy participants.
調査の概要
研究の種類
入学 (推定)
段階
- フェーズ 1
連絡先と場所
研究連絡先
- 名前:Amgen Call Center
- 電話番号:866-572-6436
- メール:medinfo@amgen.com
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Healthy adults, male or female, 18 to 60 years of age.
- Able and willing to provide written informed consent before any study procedures.
- Body weight between 45.0 kg and 95.0 kg (inclusive).
- Women must not be able to become pregnant (for example, postmenopausal or permanently sterile, as defined by the protocol).
- Men who can father a child must agree to use the required contraception during the study and for 3 months after the study drug dose.
- Willing and able to take daily calcium (500 to 2,000 mg elemental calcium) and vitamin D (at least 400 IU) supplements from Day 1 through the end of the study.
Exclusion Criteria:
- Any clinically significant medical condition or abnormal finding that, in the opinion of the study doctor, could make participation unsafe or interfere with the study or its results.
- Clinically significant abnormalities on medical history, physical examination, vital signs, electrocardiogram (ECG), or laboratory tests, including suspected Gilbert syndrome.
- History or current signs or symptoms of significant cardiovascular disease, including heart attack, heart failure, congenital heart disease, cardiomyopathy, valve disease, angina, coronary revascularization, stroke, transient ischemic attack, or peripheral revascularization.
- Clinically significant abnormal heart rhythm or conduction disorder, including clinically significant ECG abnormalities.
- QT interval corrected for heart rate (QTcF) greater than 450 milliseconds for men or greater than 470 milliseconds for women, or a history of long QT syndrome.
- Second- or third-degree atrioventricular (AV) block.
- Systolic blood pressure greater than 140 millimeters of mercury (mmHg) or less than 90 mmHg, diastolic blood pressure greater than 90 mmHg or less than 50 mmHg, or pulse rate greater than 100 beats per minute or less than 40 beats per minute at screening or check-in.
- Deep vein thrombosis or pulmonary embolism within 3 months before screening.
- History of osteoporosis, vertebral fracture, or a fragility fracture of the wrist, upper arm, hip, or pelvis after 50 years of age.
- History of metabolic bone disease, including conditions such as Paget disease, osteomalacia, osteogenesis imperfecta, osteopetrosis, sclerosteosis, ankylosing spondylitis, rheumatoid arthritis, Cushing disease, hyperprolactinemia, or malabsorption syndrome.
- History of osteonecrosis of the jaw.
- Bone fracture within 6 months before screening.
- Vitamin D level below 20 nanograms per milliliter (ng/mL) at screening (participants may be treated and retested before enrollment).
- Current hyperparathyroidism or hypoparathyroidism.
- Kidney function below study requirements (estimated glomerular filtration rate less than 60 mL/min/1.73 m^2).
- Low or high blood calcium levels that do not meet study requirements.
- Liver blood test results (alanine aminotransferase [ALT] or aspartate aminotransferase [AST]) above the normal range.
- History of hyperthyroidism or hypothyroidism unless on stable treatment for at least 6 months with normal thyroid function tests.
- History of hearing loss caused by excessive bone growth compressing the eighth cranial nerve.
- Positive test for human immunodeficiency virus (HIV).
- Active hepatitis B or hepatitis C infection.
- Cancer within the past 5 years, except non-melanoma skin cancer or cervical or breast ductal carcinoma in situ.
- History of solid organ or bone marrow transplantation.
- History of allergy or hypersensitivity to romosozumab, its ingredients, other biologic medicines, or medicines derived from mammalian cells.
- Previous use of medications affecting bone metabolism that are not allowed by the protocol, including:
- Any intravenous or oral bisphosphonate.
- Fluoride for osteoporosis within 24 months before screening.
- Denosumab or cathepsin K inhibitors within 18 months before screening.
- Parathyroid hormone or strontium within 12 months before screening.
- Calcitonin, selective estrogen receptor modulators, or tibolone within 3 months before screening.
- Systemic corticosteroids (5 mg or more prednisone equivalent daily for more than 10 days) within 3 months before screening.
- Use of prescription or over-the-counter medications within 30 days or 5 half-lives (whichever is longer) before check-in, unless approved by the study doctor. Acetaminophen up to 2 g/day is permitted. Stable hormone replacement therapy is allowed if unchanged for at least 3 months before dosing and throughout the study.
- Use of herbal medicines, vitamins (other than study-required calcium and vitamin D), or dietary supplements within 30 days before enrollment unless approved by the study doctor.
- Currently participating in another clinical study, receiving another investigational treatment, or participation in another investigational drug or device study within the previous 90 days or 5 half-lives (whichever is longer).
- Previous participation in this study or previous exposure to a sclerostin antibody.
- History of alcohol abuse or regular alcohol intake greater than 14 units per week within the year before check-in.
- Alcohol use within 48 hours before check-in or unwillingness to comply with study alcohol restrictions.
- Positive alcohol test at check-in.
- Positive drug screen for illicit drugs, including cannabis, at screening or check-in.
- History of illicit drug use within 6 months before screening.
- Unwilling to avoid illicit drug use, including cannabis, throughout the study.
- Smoking more than 10 cigarettes per day or equivalent nicotine use within 1 month before check-in, or unwillingness to comply with study tobacco restrictions.
- Consumption of foods or drinks containing poppy seeds within 7 days before check-in.
- Positive pregnancy test at screening or check-in.
- Pregnant, breastfeeding, or planning to breastfeed during the study or within 3 months after receiving the study drug.
- Receipt of blood products within 2 months before check-in.
- Blood donation within 3 months before screening, plasma donation within 2 weeks before screening, or platelet donation within 6 weeks before screening.
- Poor veins that would make repeated blood sampling difficult.
- Any other reason that, in the opinion of the study doctor, would make participation unsafe or inappropriate.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:基礎科学
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的:Romosozumab Test Arm
Participants will receive a single SC injection of romosozumab (test) administered using a PFS. |
Romosozumab will be administered via SC injection using a PFS.
他の名前:
|
|
アクティブコンパレータ:Romosozumab Reference Arm
Participants will receive two SC injections of romosozumab (reference) administered using a PFS. |
Romosozumab will be administered via SC injection using a PFS.
他の名前:
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUCinf) of romosozumab
時間枠:Up to Day 85
|
Up to Day 85
|
|
Area Under the Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUClast) of romosozumab
時間枠:Up to Day 85
|
Up to Day 85
|
|
Maximum Observed Serum Concentration (Cmax) of romosozumab
時間枠:Up to Day 85
|
Up to Day 85
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Number of Participants Who Experienced Treatment-Emergent Adverse Events and Serious Adverse Events
時間枠:Up to Day 85
|
Up to Day 85
|
|
Number of Participants Who Developed Anti-romosozumab Antibodies
時間枠:Up to Day 85
|
Up to Day 85
|
協力者と研究者
スポンサー
捜査官
- スタディディレクター:MD、Amgen
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
IPD 共有時間枠
Data sharing requests relating to this trial will be considered beginning 18 months after the trial has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this trial.
IPD 共有アクセス基準
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen trial/trials in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。