Last updated: 11/03/2018 16:20:58
China HVT safety, PK, PD
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Randomized, Single-blind, Parallel-group, Placebo-controlled, Single-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Denosumab Administered Subcutaneously to Healthy Adults in China
Trial description: This study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of denosumab administered subcutaneously to healthy adults in China.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Single (Participant)
Allocation:
Randomized
Primary outcomes:
adverse events
Timeframe: up to 26 weeks
Secondary outcomes:
PK parameter estimates
Timeframe: up to 19 weeks
PD parameter estimateds
Timeframe: up to 19 weeks
Interventions:
Drug: denosumab 60mg
Drug: denosumab 120 mg
Drug: placebo
Enrollment:
64
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Osteoporosis
Product
denosumab
Collaborators
Not applicable
Study date(s)
July 2014 to February 2015
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 65 years
Accepts healthy volunteers
Yes
- Resident in China and of Chinese ancestry.
- AST, ALT, alkaline phosphatase and bilirubin ≤ 1.5xULN (isolated bilirubin > 1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin < 35%).
- A prior history or current evidence of osteomyelitis or ONJ.
- An active dental or jaw condition that requires oral surgery.
Inclusion and exclusion criteria
Inclusion criteria:
- Resident in China and of Chinese ancestry.
- AST, ALT, alkaline phosphatase and bilirubin ≤ 1.5xULN (isolated bilirubin > 1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin < 35%).
- Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
- Male or female between 18 and 65 years of age, inclusive, from date of birth, at the time of signing the informed consent.
- A female subject is eligible to participate if she is of: Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea. In questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 MlU/ml and estradiol < 40 pg/ml (< 140 pmol/L) is confirmatory. OR Child-bearing potential and agrees to use one of the contraception methods listed in Section 8.1 for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception for the duration of the study and for a minimum of 6 months after the last dose of study medication.
- Body weight of at least 50 kg and body mass index (BMI) from 19 to 24 kg/m2 at time of screening.
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- Average QTcB or QTcF < 450 msec; or QTc < 480 msec in subjects with Bundle Branch Block.
Exclusion criteria:
- A prior history or current evidence of osteomyelitis or ONJ.
- An active dental or jaw condition that requires oral surgery.
- A planned invasive dental procedure during the course of the study.
- A non-healed dental or oral surgery.
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- A positive pre-study drug/alcohol screen.
- A positive test for HIV antibody.
- A positive test for syphilis at Screening.
- Abnormal serum calcium: current hypocalcemia or hypercalcemia. Albumin-adjusted serum calcium levels must be within the normal range of the central laboratory.
- History of regular alcohol consumption within 6 months of the study defined as an average weekly intake of > 14 drinks/week for men or > 7 drinks/week for women. One drink is equivalent to (12 g alcohol) = 150 ml (5 ounces) of table wine or 360 ml (12 ounces) of beer or 45 ml (1.5 ounces) of 80 proof distilled spirits.
- The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
- Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
- History of sensitivity to any of the study medications, especially known sensitivity to mammalian-derived drug preparations, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
- Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
- Pregnant females as determined by positive serum human chorionic gonadotropin (hCG) test at screening or urine hCG test prior to dosing (day -1).
- A chest X-ray or computed tomography (CT) scan that reveals evidence of clinical significant abnormalities e.g., tuberculosis. A chest X-ray must be taken at Day-1 if a chest X-ray or CT scan is not available within 6 months prior to that day.
- Lactating females.
- Unwillingness or inability to follow the procedures outlined in the protocol.
- Subject is mentally or legally incapacitated.
- History of sensitivity to heparin or heparin-induced thrombocytopenia.
- Significant changes in physical activity during the 6 months before study drug administration or constant levels of intense physical exercise.
- Prior use of medications within 4 weeks or 5 half-lives (whichever period is greater) before and during the study. This includes medications such as, but not limited to: Estrogen-containing contraceptives Bisphosphonates Fluoride Hormone replacement therapy (i.e., tibolone, estrogen, estrogen-like compounds such as raloxifene) Calcitonin Strontium Parathyroid hormone or derivatives Supplemental vitamin D (>1000 IU/day) Glucocorticosteroids (inhaled or topical corticosteroids administered more than 2 weeks prior to enrolment are allowed) Anabolic steroids Calcitriol Diuretics
Trial location(s)
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2015-17-02
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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Additional information
Results for study 114197 can be found on the GSK Clinical Study Register.
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