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OsteoporosisPhase 1NCT02135640

China HVT Safety, PK, PD

A Phase 1 study testing denosumab 60mg and denosumab 120 mg in people with Osteoporosis, run by GlaxoSmithKline at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of denosumab administered subcutaneously to healthy adults in China. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Osteoporosis
What is being tested?
denosumab 60mg and denosumab 120 mg
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
64 participants
Where
1 siteChina
Study dates
17 Jul 2014to 17 Feb 2015
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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).
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  • 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 locations and contacts

1 site in 1 country.

China1 site

  • GSK Investigational Site

    Shanghai, 200030

Other trials in China

About this study

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

This study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of denosumab administered subcutaneously to healthy adults in China.

Read the detailed description

Denosumab is a fully human monoclonal IgG2 antibody to RANKL that being investigated as a therapeutic agent in all bone diseases characterized by excessive bone resorption, such as primary and secondary osteoporosis, metastatic bone diseases, and other diseases involving bone loss associated with increases in osteoclast function. This will be a single-blind, placebo-controlled single-dose study. All subjects will be randomized to denosuamb 60 mg, denosumab 120 mg or placebo in a ration of 3:3:2. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of denosumab administered subcutaneously to healthy adults in China. The primary endpoints for safety are: subject incidence of treatment-emergent adverse events, including clinically significant changes in physical examinations, laboratory safety tests, ECG and vital signs. The secondary endpoints are PK and PD (s-CTX1) parameter estimates.

Conditions
Osteoporosis
Being tested
denosumab 60mg, denosumab 120 mg, placebo
Medical subject headings
Osteoporosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • denosumab 60mgDrug

    solution

  • denosumab 120 mgDrug

    solution

  • placeboDrug

    solution

Study groups in NCT02135640
Study groupRoleWhat they receive
denosumab 60 mgExperimentalsolution
Receives: Drug: denosumab 60mg
denosumab 120 mgExperimentalsolution
Receives: Drug: denosumab 120 mg
placeboPlacebo comparatorsolution
Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. adverse events

    subjects incidence of treatment adverse events, including clinically-significant changes in physical examinations, laboratory safety tests, ECG and vital signs

    Measured: up to 26 weeks

Secondary outcomes (2)

  1. PK parameter estimates

    Cmax, Tmax, AUC(0-t),

    Measured: up to 19 weeks

  2. PD parameter estimateds

    serum CTX1

    Measured: up to 19 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2014 (estimated)
  2. Study start17 Jul 2014
  3. Primary completion17 Feb 2015
  4. Study completion17 Feb 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02135640
Sponsor's protocol ID
114197
Status last verified
May 2017
First submitted
8 May 2014
Last updated
10 May 2017
Results posted
No
Data monitoring committee
No

Publications

  • Chen Q, Hu C, Liu Y, Song R, Zhu W, Zhao H, Nino A, Zhang F, Liu Y. Pharmacokinetics, pharmacodynamics, safety, and tolerability of single-dose denosumab in healthy Chinese volunteers: A randomized, single-blind, placebo-controlled study. PLoS One. 2018 Jun 22;13(6):e0197984. doi: 10.1371/journal.pone.0197984. eCollection 2018.

    PubMed 29933364

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing denosumab 60mg and denosumab 120 mg in people with Osteoporosis, run by GlaxoSmithKline at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

adverse events (time frame: up to 26 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02135640, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2017.

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China HVT Safety, PK, PD (NCT02135640) | AzTrials