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

January 29, 2024 updated by: Autotelicbio

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Pharmacokinetic endpoints

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

Safety evaluation

  1. Adverse reactions (but only in case of TEAE)
  2. Concomitant drugs
  3. Vital signs
  4. Laboratory test

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gwanak-gu
      • Seoul, Gwanak-gu, Korea, Republic of, 08779
        • H Plus Yangji Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Sequence A=Reference-Test

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
Drug: ATB-101, ATB-1011, ATB-1012

  1. 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
Other Names:
  • ATB-1011 brand name: Olmetec
  • ATB-1012 brand name: Forxiga
Active Comparator: Sequence B=Test-Reference
First stage: administration of T, single dose and then Washout: 7days and then Second stage: co-administration of R1 and R2, single dose
Drug: ATB-101, ATB-1011, ATB-1012

  1. 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
Other Names:
  • ATB-1011 brand name: Olmetec
  • ATB-1012 brand name: Forxiga

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
AUCt of Olmesartan
Time Frame: Day1(first stage), Day8(scond stage)
Area under the concentration-time curve
Day1(first stage), Day8(scond stage)
Cmax of Olmesartan
Time Frame: Day1(first stage), Day8(scond stage)
Maximum concentration of drug in plasma
Day1(first stage), Day8(scond stage)
AUCt of Dapagliflozin
Time Frame: Day1(first stage), Day8(scond stage)
Area under the concentration-time curve
Day1(first stage), Day8(scond stage)
Cmax of Dapagliflozin
Time Frame: Day1(first stage), Day8(scond stage)
Maximum concentration of drug in plasma
Day1(first stage), Day8(scond stage)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
AUC∞ of Olmesartan
Time Frame: Day1(first stage), Day8(scond stage)
Area under the plasma drug concentration-time curve from time 0 to infinity
Day1(first stage), Day8(scond stage)
Tmax of Olmesartan
Time Frame: Day1(first stage), Day8(scond stage)
Time to maximum plasma concentration
Day1(first stage), Day8(scond stage)
T1/2 of Olmesartan
Time Frame: Day1(first stage), Day8(scond stage)
Terminal elimination half-life
Day1(first stage), Day8(scond stage)
CL/F of Olmesartan
Time Frame: Day1(first stage), Day8(scond stage)
Apparent total clearance of the drug from plasma after oral administration
Day1(first stage), Day8(scond stage)
Vd/F of Olmesartan
Time Frame: Day1(first stage), Day8(scond stage)
Apparent volume of distribution after non-intravenous administration
Day1(first stage), Day8(scond stage)
AUC∞ of Dapagliflozin
Time Frame: Day1(first stage), Day8(scond stage)
Area under the plasma drug concentration-time curve from time 0 to infinity
Day1(first stage), Day8(scond stage)
Tmax of Dapagliflozin
Time Frame: Day1(first stage), Day8(scond stage)
Time to maximum plasma concentration
Day1(first stage), Day8(scond stage)
T1/2 of Dapagliflozin
Time Frame: Day1(first stage), Day8(scond stage)
Terminal elimination half-life
Day1(first stage), Day8(scond stage)
CL/F of Dapagliflozin
Time Frame: Day1(first stage), Day8(scond stage)
Apparent total clearance of the drug from plasma after oral administration
Day1(first stage), Day8(scond stage)
Vd/F of Dapagliflozin
Time Frame: Day1(first stage), Day8(scond stage)
Apparent volume of distribution after non-intravenous administration
Day1(first stage), Day8(scond stage)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Autotelicbio

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jaewoo Kim, H + Yangji Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 19, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 12, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 12, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 18, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 24, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 31, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ATB-101-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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