Healthy Adult VolunteersPhase 1NCT04856969
Clinical Trial to Evaluate Pharmacokinetic Interaction of ATB-1011 and ATB-1012 in Healthy Adult Volunteers
A Phase 1 study testing Olmesartan and Dapagliflozin in people with Healthy Adult Volunteers, run by Autotelicbio at 1 site in South Korea.
Trial summary
To evaluate the interaction between two investigational products by comparing and analyzing pharmacokinetic interactions and safety in steady state after multiple oral administration of ATB-1011 or ATB-1012 alone or in combination in healthy adult volunteers. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Volunteers
- What is being tested?
- Olmesartan and Dapagliflozin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Mar 2021to 4 May 2021
- 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
- Those who are over 19 years old at the screening visit
- Those with a body mass index (BMI) between 18.0 kg/m2 and 30.0 kg/m2 with a weight of 50 kg or more (45 kg or more for women) at the screening visit
- Those who do not have clinically significant congenital or chronic diseases and have no pathological symptoms or findings upon medical examination at the screening visit
- Those who determined as suitable study subjects by the principal investigator (or a delegated sub-investigator) in result of planned and conducted laboratory tests such as hematology, blood chemistry, serum, and urine tests according to the characteristics of the investigational product.
Who cannot join
- 1) Those who have a clinically significant disease or have a history of such disease in the digestive system, cardiovascular system, endocrine system, respiratory system, blood/tumor, infectious diseases, kidney and genitourinary system, mental and nervous system, musculoskeletal system, immune system, otorhinolaryngology, skin system and ophthalmic system.
- 2) Those who have a history of gastrointestinal surgery (except for simple appendectomy or hernia surgery) that may affect the absorption of drugs or have gastrointestinal diseases 3) Those who have taken drugs that induce and inhibit metabolism enzymes such as barbital drugs within 1 month of the first administration date, or have taken drugs that may interfere with this clinical trial within 10 days of the first administration date. (However, participation is possible depending on the characteristics of pharmacokinetics and pharmacodynamics such as interactions with investigational products or half-life of concomitant drugs) 4) Those who participated in other clinical trials or bioequivalence studies and administered the investigational products within 6 months of the first administration date.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Two-arm, Open-label, Single-sequence, Multiple Oral Dosings, Cross-over Design Clinical Trial to Evaluate the Safety and Pharmacokinetic Interaction of ATB-1011 and ATB-1012 in Healthy Adult Volunteers
To evaluate the interaction between two investigational products by comparing and analyzing pharmacokinetic interactions and safety in steady state after multiple oral administration of ATB-1011 or ATB-1012 alone or in combination in healthy adult volunteers.
Read the detailed description
- Arm A: To evaluate the effect of ATB-1012 on the safety and pharmacokinetic properties of ATB-1011 in steady state.
- Arm B: To evaluate the effect of ATB-1011 on the safety and pharmacokinetic properties of ATB-1012 in steady state.
- Conditions
- Healthy Adult Volunteers
- Being tested
- Olmesartan, Dapagliflozin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlmesartanDrug
Also called brand name: Olmetec
First stage: ATB-1011 for 5days, repeated administration, Second stage: ATB-1012 + ATB-1011 for 5days, repeated administration
DapagliflozinDrug
Also called brand name: Forxiga
First stage: ATB-1012 for 5days, repeated administration, Second stage: ATB-1012 + ATB-1011 for 5days, repeated administration
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Active comparator | ATB-1011: 1tab/d for 5days , ATB-1011+ATB-1012: each 1tab/d for 5days Receives: Drug: Olmesartan; Drug: Dapagliflozin |
| Arm B | Active comparator | ATB-1012: 1tab/d for 5days / ATB-1011+ATB-1012: each 1tab/d for 5days Receives: Drug: Olmesartan; Drug: Dapagliflozin |
What is being measured
The primary outcome is the main question the study is designed to answer.
ATB-1011 AUCτ,ss
the primary endpoints, are converted into natural logarithms, and a point estimate of the difference between the mean values of single and co-administration and 90% confidence intervals thereof is evaluated to evaluate the pharmacokinetic properties.
Measured: 5days, 10days
ATB-1012 AUCτ,ss,
the primary endpoints, are converted into natural logarithms, and a point estimate of the difference between the mean values of single and co-administration and 90% confidence intervals thereof is evaluated to evaluate the pharmacokinetic properties.
Measured: 5days, 10days
ATB-1011 Cmax,ss
the primary endpoints, are converted into natural logarithms, and a point estimate of the difference between the mean values of single and co-administration and 90% confidence intervals thereof is evaluated to evaluate the pharmacokinetic properties.
Measured: 5days, 10days
ATB-1012 Cmax,ss
the primary endpoints, are converted into natural logarithms, and a point estimate of the difference between the mean values of single and co-administration and 90% confidence intervals thereof is evaluated to evaluate the pharmacokinetic properties.
Measured: 5days, 10days
Secondary outcomes (4)
ATB-1011 Tmax,ss
Pharmacokinetic parameters are calculated using a noncompartmental method and descriptive statistics of pharmacokinetic endpoints are presented for each investigational product administration group.
Measured: 5days, 10days
ATB-1011 Cmin,ss
Pharmacokinetic parameters are calculated using a noncompartmental method and descriptive statistics of pharmacokinetic endpoints are presented for each investigational product administration group.
Measured: 5days, 10days
ATB-1012 Tmax,ss
Pharmacokinetic parameters are calculated using a noncompartmental method and descriptive statistics of pharmacokinetic endpoints are presented for each investigational product administration group.
Measured: 5days, 10days
ATB-1012 Cmin,ss
Pharmacokinetic parameters are calculated using a noncompartmental method and descriptive statistics of pharmacokinetic endpoints are presented for each investigational product administration group.
Measured: 5days, 10days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2021
- Study start30 Mar 2021
- Primary completion4 May 2021
- Study completion4 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult VolunteersStudies 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
- Non-randomised
- Intervention model
- Crossover
- Model description
- 2 Intervention group, open, single-sequence, multiple oral administration crossover design
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Autotelicbio
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- KyungWan Nam, Pharm. D., Principal investigator, Autotelic.bio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04856969
- Sponsor's protocol ID
- ATB-101-001
- Status last verified
- Aug 2021
- First submitted
- 20 Apr 2021
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-arm, Open-label, Single-sequence, Multiple Oral Dosings, Cross-over Design Clinical Trial to Evaluate the Safety and Pharmacokinetic Interaction of ATB-1011 and ATB-1012 in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT04856969
- Acronym / sponsor ID
- ATB-101-001
- Conditions
- Healthy Adult Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- AutotelicbioIndustry (pharma, biotech, devices)
- Study start
- 30 Mar 2021 (actual)
- Primary completion
- 4 May 2021 (actual)
- Study completion
- 4 May 2021 (actual)
- First posted
- 23 Apr 2021 (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.
To evaluate the interaction between two investigational products by comparing and analyzing pharmacokinetic interactions and safety in steady state after multiple oral administration of ATB-1011 or ATB-1012 alone or in combination in healthy adult volunteers.
Detailed description
- Arm A: To evaluate the effect of ATB-1012 on the safety and pharmacokinetic properties of ATB-1011 in steady state.
- Arm B: To evaluate the effect of ATB-1011 on the safety and pharmacokinetic properties of ATB-1012 in steady state.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2 Intervention group, open, single-sequence, multiple oral administration crossover design
| Arm | Type | Receives |
|---|---|---|
| Arm A | Active comparator | Drug: Olmesartan, Drug: DapagliflozinATB-1011: 1tab/d for 5days , ATB-1011+ATB-1012: each 1tab/d for 5days |
| Arm B | Active comparator | Drug: Olmesartan, Drug: DapagliflozinATB-1012: 1tab/d for 5days / ATB-1011+ATB-1012: each 1tab/d for 5days |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Those who are over 19 years old at the screening visit
- Those with a body mass index (BMI) between 18.0 kg/m2 and 30.0 kg/m2 with a weight of 50 kg or more (45 kg or more for women) at the screening visit
- Those who do not have clinically significant congenital or chronic diseases and have no pathological symptoms or findings upon medical examination at the screening visit
- Those who determined as suitable study subjects by the principal investigator (or a delegated sub-investigator) in result of planned and conducted laboratory tests such as hematology, blood chemistry, serum, and urine tests according to the characteristics of the investigational product.
Key exclusion criteria (2 listed)
- 1) Those who have a clinically significant disease or have a history of such disease in the digestive system, cardiovascular system, endocrine system, respiratory system, blood/tumor, infectious diseases, kidney and genitourinary system, mental and nervous system, musculoskeletal system, immune system, otorhinolaryngology, skin system and ophthalmic system.
- 2) Those who have a history of gastrointestinal surgery (except for simple appendectomy or hernia surgery) that may affect the absorption of drugs or have gastrointestinal diseases 3) Those who have taken drugs that induce and inhibit metabolism enzymes such as barbital drugs within 1 month of the first administration date, or have taken drugs that may interfere with this clinical trial within 10 days of the first administration date. (However, participation is possible depending on the characteristics of pharmacokinetics and pharmacodynamics such as interactions with investigational products or half-life of concomitant drugs) 4) Those who participated in other clinical trials or bioequivalence studies and administered the investigational products within 6 months of the first administration date.
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 |
|---|---|---|
| OlmesartanAlso: brand name: OlmetecFirst stage: ATB-1011 for 5days, repeated administration, Second stage: ATB-1012 + ATB-1011 for 5days, repeated administration | Drug | Arm A, Arm B |
| DapagliflozinAlso: brand name: ForxigaFirst stage: ATB-1012 for 5days, repeated administration, Second stage: ATB-1012 + ATB-1011 for 5days, repeated administration | Drug | Arm A, Arm B |
Primary outcome
ATB-1011 AUCτ,ss
Time frame: 5days, 10days
the primary endpoints, are converted into natural logarithms, and a point estimate of the difference between the mean values of single and co-administration and 90% confidence intervals thereof is evaluated to evaluate the pharmacokinetic properties.
ATB-1012 AUCτ,ss,
Time frame: 5days, 10days
the primary endpoints, are converted into natural logarithms, and a point estimate of the difference between the mean values of single and co-administration and 90% confidence intervals thereof is evaluated to evaluate the pharmacokinetic properties.
ATB-1011 Cmax,ss
Time frame: 5days, 10days
the primary endpoints, are converted into natural logarithms, and a point estimate of the difference between the mean values of single and co-administration and 90% confidence intervals thereof is evaluated to evaluate the pharmacokinetic properties.
ATB-1012 Cmax,ss
Time frame: 5days, 10days
the primary endpoints, are converted into natural logarithms, and a point estimate of the difference between the mean values of single and co-administration and 90% confidence intervals thereof is evaluated to evaluate the pharmacokinetic properties.
4 secondary outcomes
ATB-1011 Tmax,ss
Time frame: 5days, 10days
ATB-1011 Cmin,ss
Time frame: 5days, 10days
ATB-1012 Tmax,ss
Time frame: 5days, 10days
ATB-1012 Cmin,ss
Time frame: 5days, 10days
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 5 Sep 2021.
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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.
KyungWan Nam, Pharm. D. principal investigator
Autotelic.bio
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 Olmesartan and Dapagliflozin in people with Healthy Adult Volunteers, run by Autotelicbio 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 4 inclusion and 2 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 5 Sep 2021. 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?
ATB-1011 AUCτ,ss (time frame: 5days, 10days). 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 5 Sep 2021.