OsteoporosisPhase 1NCT03764462
Evaluating the Pharmacokinetic Characteristics of AD-101 in Healthy Volunteers
A Phase 1 study testing AD-101 45mg and Raloxifene 60mg in people with Osteoporosis, run by Addpharma Inc. at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the pharmacokinetic characteristics of AD-101 in healthy 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
- What is being tested?
- AD-101 45mg and Raloxifene 60mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteSouth Korea
- Study dates
- 14 Dec 2018to 8 Feb 2019
- 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
- Healthy Adult aged 19 and more at the time of screening visit
- Body mass index (BMI) between 17.5 kg/m2 and 30.5 kg/m2 at the time of screening visit
- No evidence of medical symptoms or signs of congenital or no chronic disease within the last 3 years as a result of medical examination
Who cannot join
- Evidence of clinically significant blood, kidney, endocrine, respiratory, gastrointestinal, urinary, cardiovascular, liver, nerve or allergic disease (except for asymptomatic seasonal allergy untreated at the time of administration)
- History of gastrointestinal disorders (esophageal ataxia or esophageal strictures, Crohn's disease, etc.) or surgery (excluding simple cecal surgery or hernia surgery) that may affect the absorption of drugs
- As a result of laboratory tests, the following figures: ALT or AST> 2 times upper limit of normal range
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-label, Single Dose, Crossover Study to Evaluate the Pharmacokinetic Characteristics of AD-101 in Healthy Volunteers
The purpose of this study is to evaluate the pharmacokinetic characteristics of AD-101 in healthy volunteers
Read the detailed description
This study is to evaluate the pharmacokinetic characteristics and safety of AD-101 compared with administration of raloxifen 60 mg in healthy adults
- Conditions
- Osteoporosis
- Being tested
- AD-101 45mg, Raloxifene 60mg
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AD-101 45mgDrug
Also called AD-101
Raloxifene 45mg tablet
Raloxifene 60mgDrug
Raloxifene 60mg tablet
| Study group | Role | What they receive |
|---|---|---|
| Raloxifene 60mg to AD-101 45mg | Experimental | Period 1: Raloxifene 60mg, 1 tab, QD, Per oral / Period 2: AD-101 45mg, 1 tab, QD, Per oral Receives: Drug: AD-101 45mg; Drug: Raloxifene 60mg |
| AD-101 45mg to Raloxifene 60mg | Experimental | Period 1: AD-101 45mg, 1 tab, QD, Per oral / Period 2: Raloxifene 60mg, 1 tab, QD, Per oral Receives: Drug: AD-101 45mg; Drug: Raloxifene 60mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Plasma Concentration (Cmax)
Cmax of the total ingredient of AD-101
Measured: pre-dose to 96 hours
Area under the curve in time plot (AUCt)
AUCt of the total ingredient of AD-101
Measured: pre-dose to 96 hours
Secondary outcomes (5)
Area under the curve in time plot (AUCinf)
AUCinf of the total ingredient of AD-101
Measured: pre-dose to 96 hours
Time to reach Cmax
Tmax of the total ingredient of AD-101
Measured: pre-dose to 96 hours
Effective half-life
t1/2 of the total ingredient of AD-101
Measured: pre-dose to 96 hours
Clearance
CL/F of the total ingredient of AD-101
Measured: pre-dose to 96 hours
Volume of distribution
Vd/F of the total ingredient of AD-101
Measured: pre-dose to 96 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2018
- Study start14 Dec 2018
- Primary completion2 Jan 2019
- Study completion8 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by Addpharma Inc.The sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Addpharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Young-Ran Yoon, M.D., Ph.D, Principal investigator, Kyungpook National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03764462
- Sponsor's protocol ID
- AD-101BE
- Status last verified
- Aug 2019
- First submitted
- 3 Dec 2018
- Last updated
- 30 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Single Dose, Crossover Study to Evaluate the Pharmacokinetic Characteristics of AD-101 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03764462
- Acronym / sponsor ID
- AD-101BE
- Conditions
- Osteoporosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Addpharma Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Dec 2018 (actual)
- Primary completion
- 2 Jan 2019 (actual)
- Study completion
- 8 Feb 2019 (actual)
- First posted
- 5 Dec 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.
The purpose of this study is to evaluate the pharmacokinetic characteristics of AD-101 in healthy volunteers
Detailed description
This study is to evaluate the pharmacokinetic characteristics and safety of AD-101 compared with administration of raloxifen 60 mg in healthy adults
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Raloxifene 60mg to AD-101 45mg | Experimental | Drug: AD-101 45mg, Drug: Raloxifene 60mgPeriod 1: Raloxifene 60mg, 1 tab, QD, Per oral / Period 2: AD-101 45mg, 1 tab, QD, Per oral |
| AD-101 45mg to Raloxifene 60mg | Experimental | Drug: AD-101 45mg, Drug: Raloxifene 60mgPeriod 1: AD-101 45mg, 1 tab, QD, Per oral / Period 2: Raloxifene 60mg, 1 tab, QD, Per oral |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy Adult aged 19 and more at the time of screening visit
- Body mass index (BMI) between 17.5 kg/m2 and 30.5 kg/m2 at the time of screening visit
- No evidence of medical symptoms or signs of congenital or no chronic disease within the last 3 years as a result of medical examination
Key exclusion criteria (3 listed)
- Evidence of clinically significant blood, kidney, endocrine, respiratory, gastrointestinal, urinary, cardiovascular, liver, nerve or allergic disease (except for asymptomatic seasonal allergy untreated at the time of administration)
- History of gastrointestinal disorders (esophageal ataxia or esophageal strictures, Crohn's disease, etc.) or surgery (excluding simple cecal surgery or hernia surgery) that may affect the absorption of drugs
- As a result of laboratory tests, the following figures: ALT or AST> 2 times upper limit of normal range
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 |
|---|---|---|
| AD-101 45mgAlso: AD-101Raloxifene 45mg tablet | Drug | AD-101 45mg to Raloxifene 60mg, Raloxifene 60mg to AD-101 45mg |
| Raloxifene 60mgRaloxifene 60mg tablet | Drug | AD-101 45mg to Raloxifene 60mg, Raloxifene 60mg to AD-101 45mg |
Primary outcome
Peak Plasma Concentration (Cmax)
Time frame: pre-dose to 96 hours
Cmax of the total ingredient of AD-101
Area under the curve in time plot (AUCt)
Time frame: pre-dose to 96 hours
AUCt of the total ingredient of AD-101
5 secondary outcomes
Area under the curve in time plot (AUCinf)
Time frame: pre-dose to 96 hours
Time to reach Cmax
Time frame: pre-dose to 96 hours
Effective half-life
Time frame: pre-dose to 96 hours
Clearance
Time frame: pre-dose to 96 hours
Volume of distribution
Time frame: pre-dose to 96 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2019.
- Individual participant dataSharing planned: No
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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.
Young-Ran Yoon, M.D., Ph.D principal investigator
Kyungpook National University Hospital
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 AD-101 45mg and Raloxifene 60mg in people with Osteoporosis, run by Addpharma Inc. 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 3 inclusion and 3 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 30 Aug 2019. 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?
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?
Peak Plasma Concentration (Cmax) (time frame: pre-dose to 96 hours). The study lists 2 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 30 Aug 2019.