Healthy Adult VolunteersPhase 1NCT05017987

Clinical Trial to Compare Pharmacokinetics After Administration of ATB-101 or Co-administration of ATB-1011 and ATB-1012

A Phase 1 study testing ATB-101, ATB-1011, ATB-1012 in people with Healthy Adult Volunteers, run by Autotelicbio at 1 site in South Korea.

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

To compare and evaluate safety and pharmacokinetic Characteristics after administration of ATB-101 or co-administration of ATB-1011 and ATB-1012 in fasted 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?: ATB-101, ATB-1011, ATB-1012
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: 1 siteSouth Korea
Study dates: 19 Jun 2021to 12 Jul 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 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
A person who signs the consent form at will, after hearing and understanding a sufficient explanation of the purpose, contents, characteristics of the investigational product, and expected adverse reactions of this clinical trial

Who cannot join

Those who have a clinically significant disease or have a history of such disease
Those who have a history of gastrointestinal surgery
Those who have taken drugs that induce and inhibit metabolism enzymes such as barbital drugs
Those who participated in other clinical trials or bioequivalence studies and administered the investigational products within 6 months of the first administration date.
Those who donated whole blood within 2 months or donated components within 2 weeks, or received a blood transfusion within 1 month of the first administration date

Trial locations and contacts

1 site in 1 country.

South Korea1 site

H Plus Yangji Hospital
Seoul, Gwanak-gu, 08779

Other trials in South Korea

About this study

Official title: A Phase I Clinical Trial to Compare and Evaluate Safety and Pharmacokinetic Characteristics After Administration of ATB-101 or Co-administration of ATB-1011 and ATB-1012 in Healthy Adult Volunteers

To compare and evaluate safety and pharmacokinetic Characteristics after administration of ATB-101 or co-administration of ATB-1011 and ATB-1012 in fasted Healthy Adult Volunteers

Read the detailed description

Pharmacokinetic endpoints

Primary endpoint : AUCt, Cmax of Dapagliflozin, Olmesartan
Secondary endpoint : AUC∞, Tmax, t1/2, CL/F, Vd/F of Dapagliflozin, Olmesartan

Safety evaluation

Adverse reactions (but only in case of TEAE)
Concomitant drugs
Vital signs
Laboratory test

Conditions: Healthy Adult Volunteers
Being tested: ATB-101, ATB-1011, ATB-1012

What participants receive

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

ATB-101, ATB-1011, ATB-1012Drug
Also called ATB-1011 brand name: Olmetec, ATB-1012 brand name: Forxiga
1. Test drug
- Code name: ATB-101
1. Control drug1
- Code name: ATB-1011
- Active ingredient: Olmesartan
1. Control drug2
- Code name: ATB-1012
- Active ingredient: Dapagliflozin

Study groups in NCT05017987
Study group	Role	What they receive
Sequence A=Reference-Test	Active comparator	T(Test drug): ATB-101 R1(Reference drug1): ATB-1011 R2(Reference drug2): ATB-1012 First stage: co-administration of R1 and R2, single dose and then Washout: 7days and then Second stage: administration of T, single dose Receives: Drug: ATB-101, ATB-1011, ATB-1012
Sequence B=Test-Reference	Active comparator	First stage: administration of T, single dose and then Washout: 7days and then Second stage: co-administration of R1 and R2, single dose Receives: Drug: ATB-101, ATB-1011, ATB-1012

What is being measured

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

AUCt of Olmesartan
Area under the concentration-time curve
Measured: Day1(first stage), Day8(scond stage)
Cmax of Olmesartan
Maximum concentration of drug in plasma
Measured: Day1(first stage), Day8(scond stage)
AUCt of Dapagliflozin
Area under the concentration-time curve
Measured: Day1(first stage), Day8(scond stage)
Cmax of Dapagliflozin
Maximum concentration of drug in plasma
Measured: Day1(first stage), Day8(scond stage)

Secondary outcomes (10)

AUC∞ of Olmesartan
Area under the plasma drug concentration-time curve from time 0 to infinity
Measured: Day1(first stage), Day8(scond stage)
Tmax of Olmesartan
Time to maximum plasma concentration
Measured: Day1(first stage), Day8(scond stage)
T1/2 of Olmesartan
Terminal elimination half-life
Measured: Day1(first stage), Day8(scond stage)
CL/F of Olmesartan
Apparent total clearance of the drug from plasma after oral administration
Measured: Day1(first stage), Day8(scond stage)
Vd/F of Olmesartan
Apparent volume of distribution after non-intravenous administration
Measured: Day1(first stage), Day8(scond stage)
AUC∞ of Dapagliflozin
Area under the plasma drug concentration-time curve from time 0 to infinity
Measured: Day1(first stage), Day8(scond stage)
Tmax of Dapagliflozin
Time to maximum plasma concentration
Measured: Day1(first stage), Day8(scond stage)
T1/2 of Dapagliflozin
Terminal elimination half-life
Measured: Day1(first stage), Day8(scond stage)
CL/F of Dapagliflozin
Apparent total clearance of the drug from plasma after oral administration
Measured: Day1(first stage), Day8(scond stage)
Vd/F of Dapagliflozin
Apparent volume of distribution after non-intravenous administration
Measured: Day1(first stage), Day8(scond stage)

Timeline

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

19 Jun 202112 Jul 2021

First posted24 Aug 2021
Study start19 Jun 2021
Primary completion12 Jul 2021
Study completion12 Jul 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: Randomised
Intervention model: Crossover
Model description: Open, Randomization, single oral administration, 2 Intervention group, crossover design
Masking: None (open label)
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05017987
Sponsor's protocol ID: ATB-101-002
Status last verified: Jan 2024
First submitted: 18 Aug 2021
Last updated: 31 Jan 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy Adult Volunteers trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I Clinical Trial to Compare and Evaluate Safety and Pharmacokinetic Characteristics After Administration of ATB-101 or Co-administration of ATB-1011 and ATB-1012 in Healthy Adult Volunteers
ClinicalTrials.gov ID: NCT05017987
Acronym / sponsor ID: ATB-101-002
Conditions: Healthy Adult Volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: AutotelicbioIndustry (pharma, biotech, devices)
Study start: 19 Jun 2021 (actual)
Primary completion: 12 Jul 2021 (actual)
Study completion: 12 Jul 2021 (actual)
First posted: 24 Aug 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 compare and evaluate safety and pharmacokinetic Characteristics after administration of ATB-101 or co-administration of ATB-1011 and ATB-1012 in fasted Healthy Adult Volunteers

Detailed description

Pharmacokinetic endpoints

Primary endpoint : AUCt, Cmax of Dapagliflozin, Olmesartan
Secondary endpoint : AUC∞, Tmax, t1/2, CL/F, Vd/F of Dapagliflozin, Olmesartan

Safety evaluation

Adverse reactions (but only in case of TEAE)
Concomitant drugs
Vital signs
Laboratory test

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2
Model description: Open, Randomization, single oral administration, 2 Intervention group, crossover design

Arm	Type	Receives
Sequence A=Reference-Test	Active comparator	Drug: ATB-101, ATB-1011, ATB-1012T(Test drug): ATB-101 R1(Reference drug1): ATB-1011 R2(Reference drug2): ATB-1012 First stage: co-administration of R1 and R2, single dose and then Washout: 7days and then Second stage: administration of T, single dose
Sequence B=Test-Reference	Active comparator	Drug: ATB-101, ATB-1011, ATB-1012First stage: administration of T, single dose and then Washout: 7days and then Second stage: co-administration of R1 and R2, single dose

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 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
A person who signs the consent form at will, after hearing and understanding a sufficient explanation of the purpose, contents, characteristics of the investigational product, and expected adverse reactions of this clinical trial

Key exclusion criteria (5 listed)

Those who have a clinically significant disease or have a history of such disease
Those who have a history of gastrointestinal surgery
Those who have taken drugs that induce and inhibit metabolism enzymes such as barbital drugs
Those who participated in other clinical trials or bioequivalence studies and administered the investigational products within 6 months of the first administration date.
Those who donated whole blood within 2 months or donated components within 2 weeks, or received a blood transfusion within 1 month 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
ATB-101, ATB-1011, ATB-1012Also: ATB-1011 brand name: Olmetec, ATB-1012 brand name: Forxiga1. Test drug - Code name: ATB-101 2. Control drug1 * Code name: ATB-1011 * Active ingredient: Olmesartan 3. Control drug2 * Code name: ATB-1012 * Active ingredient: Dapagliflozin	Drug	Sequence A=Reference-Test, Sequence B=Test-Reference

Primary outcome

AUCt of Olmesartan
Time frame: Day1(first stage), Day8(scond stage)
Area under the concentration-time curve
Cmax of Olmesartan
Time frame: Day1(first stage), Day8(scond stage)
Maximum concentration of drug in plasma
AUCt of Dapagliflozin
Time frame: Day1(first stage), Day8(scond stage)
Area under the concentration-time curve
Cmax of Dapagliflozin
Time frame: Day1(first stage), Day8(scond stage)
Maximum concentration of drug in plasma

10 secondary outcomes

AUC∞ of Olmesartan
Time frame: Day1(first stage), Day8(scond stage)
Tmax of Olmesartan
Time frame: Day1(first stage), Day8(scond stage)
T1/2 of Olmesartan
Time frame: Day1(first stage), Day8(scond stage)
CL/F of Olmesartan
Time frame: Day1(first stage), Day8(scond stage)
Vd/F of Olmesartan
Time frame: Day1(first stage), Day8(scond stage)
AUC∞ of Dapagliflozin
Time frame: Day1(first stage), Day8(scond stage)
Tmax of Dapagliflozin
Time frame: Day1(first stage), Day8(scond stage)
T1/2 of Dapagliflozin
Time frame: Day1(first stage), Day8(scond stage)
CL/F of Dapagliflozin
Time frame: Day1(first stage), Day8(scond stage)
Vd/F of Dapagliflozin
Time frame: Day1(first stage), Day8(scond stage)

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 31 Jan 2024.
Individual participant dataSharing planned: No

Related trials for Healthy Adult Volunteers

RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
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Smartphone Camera Measurement of Breathing-Related Heart Rate Variability Compared With ECG in Healthy Adults
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Recruiting
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A Study of Multiple Doses of Orally Administered RO7795081 in Otherwise Healthy Chinese Adult Participants With Obesity or Overweight
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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.

Jaewoo Kim principal investigator

H + Yangji 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 ATB-101, ATB-1011, ATB-1012 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 5 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 31 Jan 2024. 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?

AUCt of Olmesartan (time frame: Day1(first stage), Day8(scond stage)). 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?

On the ClinicalTrials.gov record for NCT05017987.

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 31 Jan 2024.