Osteoporosis, PostmenopausalPhase 1NCT03475719
A Clinical Trial to Evaluate the Safety and Pharmacokinetic
A Phase 1 study testing HUG186-B and HUG186-D and HUG186 in people with Osteoporosis, Postmenopausal, run by Huons Co., Ltd. at 1 site in South Korea.
Trial summary
A phase 1 clinical trail to evaluate the safety and pharmacokinetic characteristic after administration of fixed-dose combination or loose combination of HUG186 in healthy adult male or menopausal female volunteers Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis, Postmenopausal
- What is being tested?
- HUG186-B and HUG186-D and HUG186
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 Jan 2018to 30 Apr 2018
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men, age≥19 years of age, Postmenopausal women are eligible. Postmenopausal is defined as any of the following:
- Amenorrhea for 12 or more months
- FSH and estradiol in the postmenopausal range per local normal range.
- Body weight of ≥ 55 kg, BMI 18.5 to 30.0
- No morbid symptom or sign, based on physical examination, with no innate or chronic disease.
- Subject that is considered appropriate for participating in the study by an investigator, based on clinical laboratory test (hematology, clinical chemistry, urinalysis) that is performed according to the characteristics of investigational drugs.
- Subject that agree to apply sun cream in case of daylight exposure for more than 1hours
- Subjects must be able to listen to and understand the detailed statement of informed consent, and willing to decide to participate in the study, follow the study directions and provide written informed consent.
Who cannot join
- A clinically significant disease or history in hepatobiliary system, kidney, digestive system, respiratory system, hemato-oncological system, endocrine system, neuro-psychiatric system, musculo-skeletal system, immune system, otorhinolaryngological system or cardiovascular system.
- A history of hypersensitivity to investigational drugs and its additives or clinically significant hypersensitivity to any other drug.
- History of drug abuse, or positive in drug screening test.
- Use of inducer or inhibitor of metabolic enzymes for drugs like barbiturate.
- Use of any prescribed drugs or herbal remedies within 2 weeks, or use of any over-the-counter medication within 1 week prior to the first administration of investigational drug, and this will affect this study or the safety of the subjects at discretion of study investigator.
- Participation in another clinical trial or a bioequivalent study within 3 months prior to the first administration of investigational drug (The finish time of previous study is the day of the last administration of study drug)
Show all 10Show fewer
- Whole blood donation within 2 months or component donation within 1 month, prior to the first administration of investigational drug, or transfusion within 1 month prior to the first administration of investigational drug.
- Prolonged excessive alcohol consumption (>21 units/week, 1 unit=10g of pure alcohol), or subjects who can not abstain from drinking from 24 hours prior to hospitalization until the discharge.
- Smoking more than 10 cigarettes per day, excessive caffeine consumption (example: instant coffee > 5 cups/day)
- Subjects who are judged to be inappropriate for this study by investigators according to other reasons including clinical lab test result
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Clinical Trial to Evaluate the Safety and Pharmacokinetic Characteristic After Administration of Fixed-dose Combination or Loose Combination of HUG186 in Healthy Adult Male or Menopausal Female Volunteers
A phase 1 clinical trail to evaluate the safety and pharmacokinetic characteristic after administration of fixed-dose combination or loose combination of HUG186 in healthy adult male or menopausal female volunteers
- Conditions
- Osteoporosis, Postmenopausal
- Being tested
- HUG186-B and HUG186-D, HUG186
- Medical subject headings
- Osteoporosis, Postmenopausal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HUG186-B and HUG186-DDrug
Bazedoxifene acetate 22.6mg, Cholecalciferol 8.0mg(=800IU)
HUG186Drug
Combination of Bazedoxifene acetate 22.6mg and Cholecalciferol 8.0mg(=800IU)
| Study group | Role | What they receive |
|---|---|---|
| HUG186-B and HUG186-D | Active comparator | Bazedoxifene acetate 22.6mg, Cholecalciferol 8.0mg(=800IU) Receives: Drug: HUG186-B and HUG186-D |
| HUG186 | Experimental | Combination of Bazedoxifene acetate 22.6mg and Cholecalciferol 8.0mg(=800IU) Receives: Drug: HUG186 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-t of Bazedoxifene
Area under the curve(AUCt) of Bazedoxifene
Measured: 0, 0.17, 0.33, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120h(17points)
Cmax of Bazedoxifene
Maximum observed concentration(Cmax) of Bazedoxifene
Measured: 0, 0.17, 0.33, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120h(17points)
AUC0-t of Cholecalciferol
Area under the curve(AUCt) of Cholecalciferol
Measured: -24, -12, -6, 0, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96h(18points)
Cmax of Cholecalciferol
Maximum observed concentration(Cmax) of Cholecalciferol
Measured: -24, -12, -6, 0, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96h(18points)
Secondary outcomes (6)
Tmax of Bazedoxifene
Tmax of Bazedoxifene
Measured: 0, 0.17, 0.33, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120h(17points)
AUCinf of Bazedoxifene
AUCinf of Bazedoxifene
Measured: 0, 0.17, 0.33, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120h(17points)
t1/2 of Bazedoxifene
t1/2 of Bazedoxifene
Measured: 0, 0.17, 0.33, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120h(17points)
Tmax of Cholecalciferol
Tmax of Cholecalciferol
Measured: -24, -12, -6, 0, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96h(18points)
AUCinf of Cholecalciferol
AUCinf of Cholecalciferol
Measured: -24, -12, -6, 0, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96h(18points)
t1/2 of Cholecalciferol
t1/2 of Cholecalciferol
Measured: -24, -12, -6, 0, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96h(18points)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2018
- Study start11 Jan 2018
- Primary completion11 Feb 2018
- Study completion30 Apr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoporosis, PostmenopausalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Crossover
- Model description
- A randomized, open-label, single-dose, two-treatment, two-sequence, two-way crossover study
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huons Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03475719
- Sponsor's protocol ID
- HUG186_P1
- Status last verified
- Mar 2018
- First submitted
- 11 Jan 2018
- Last updated
- 23 Mar 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Clinical Trial to Evaluate the Safety and Pharmacokinetic Characteristic After Administration of Fixed-dose Combination or Loose Combination of HUG186 in Healthy Adult Male or Menopausal Female Volunteers
- ClinicalTrials.gov ID
- NCT03475719
- Acronym / sponsor ID
- HUG186_P1
- Conditions
- Osteoporosis, Postmenopausal
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Huons Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 Jan 2018 (actual)
- Primary completion
- 11 Feb 2018 (actual)
- Study completion
- 30 Apr 2018 (estimated)
- First posted
- 23 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A phase 1 clinical trail to evaluate the safety and pharmacokinetic characteristic after administration of fixed-dose combination or loose combination of HUG186 in healthy adult male or menopausal female volunteers
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A randomized, open-label, single-dose, two-treatment, two-sequence, two-way crossover study
| Arm | Type | Receives |
|---|---|---|
| HUG186-B and HUG186-D | Active comparator | Drug: HUG186-B and HUG186-DBazedoxifene acetate 22.6mg, Cholecalciferol 8.0mg(=800IU) |
| HUG186 | Experimental | Drug: HUG186Combination of Bazedoxifene acetate 22.6mg and Cholecalciferol 8.0mg(=800IU) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Men, age≥19 years of age, Postmenopausal women are eligible. Postmenopausal is defined as any of the following:
- Body weight of ≥ 55 kg, BMI 18.5 to 30.0
- No morbid symptom or sign, based on physical examination, with no innate or chronic disease.
- Subject that is considered appropriate for participating in the study by an investigator, based on clinical laboratory test (hematology, clinical chemistry, urinalysis) that is performed according to the characteristics of investigational drugs.
- Subject that agree to apply sun cream in case of daylight exposure for more than 1hours
Key exclusion criteria (10 listed)
- A clinically significant disease or history in hepatobiliary system, kidney, digestive system, respiratory system, hemato-oncological system, endocrine system, neuro-psychiatric system, musculo-skeletal system, immune system, otorhinolaryngological system or cardiovascular system.
- A history of hypersensitivity to investigational drugs and its additives or clinically significant hypersensitivity to any other drug.
- History of drug abuse, or positive in drug screening test.
- Use of inducer or inhibitor of metabolic enzymes for drugs like barbiturate.
- Use of any prescribed drugs or herbal remedies within 2 weeks, or use of any over-the-counter medication within 1 week prior to the first administration of investigational drug, and this will affect this study or the safety of the subjects at discretion of study investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HUG186-B and HUG186-DBazedoxifene acetate 22.6mg, Cholecalciferol 8.0mg(=800IU) | Drug | HUG186-B and HUG186-D |
| HUG186Combination of Bazedoxifene acetate 22.6mg and Cholecalciferol 8.0mg(=800IU) | Drug | HUG186 |
Primary outcome
AUC0-t of Bazedoxifene
Time frame: 0, 0.17, 0.33, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120h(17points)
Area under the curve(AUCt) of Bazedoxifene
Cmax of Bazedoxifene
Time frame: 0, 0.17, 0.33, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120h(17points)
Maximum observed concentration(Cmax) of Bazedoxifene
AUC0-t of Cholecalciferol
Time frame: -24, -12, -6, 0, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96h(18points)
Area under the curve(AUCt) of Cholecalciferol
Cmax of Cholecalciferol
Time frame: -24, -12, -6, 0, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96h(18points)
Maximum observed concentration(Cmax) of Cholecalciferol
6 secondary outcomes
Tmax of Bazedoxifene
Time frame: 0, 0.17, 0.33, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120h(17points)
AUCinf of Bazedoxifene
Time frame: 0, 0.17, 0.33, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120h(17points)
t1/2 of Bazedoxifene
Time frame: 0, 0.17, 0.33, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120h(17points)
Tmax of Cholecalciferol
Time frame: -24, -12, -6, 0, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96h(18points)
AUCinf of Cholecalciferol
Time frame: -24, -12, -6, 0, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96h(18points)
t1/2 of Cholecalciferol
Time frame: -24, -12, -6, 0, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96h(18points)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HUG186-B and HUG186-D and HUG186 in people with Osteoporosis, Postmenopausal, run by Huons Co., Ltd. at 1 site in South Korea.
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 8 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 23 Mar 2018. 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 South Korea. 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. 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?
Results are not available in the source record.
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?
AUC0-t of Bazedoxifene (time frame: 0, 0.17, 0.33, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120h(17points)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Mar 2018.