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Clinical Trial to Evaluate Pharmacokinetic Interaction of ATB-1011 and ATB-1012 in Healthy Adult Volunteers

Sponsor
Autotelicbio (Industry)
Overall Status
Completed
CT.gov ID
NCT04856969
Collaborator
(none)
38
Enrollment
1
Location
2
Arms
1.1
Actual Duration (Months)
33
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 1

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

Study Type:
Interventional
Actual Enrollment :
38 participants
Allocation:
Non-Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
2 Intervention group, open, single-sequence, multiple oral administration crossover design2 Intervention group, open, single-sequence, multiple oral administration crossover design
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Mar 30, 2021
Actual Primary Completion Date :
May 4, 2021
Actual Study Completion Date :
May 4, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Arm A

ATB-1011: 1tab/d for 5days , ATB-1011+ATB-1012: each 1tab/d for 5days

Drug: Olmesartan
First stage: ATB-1011 for 5days, repeated administration, Second stage: ATB-1012 + ATB-1011 for 5days, repeated administration
Other Names:
  • brand name: Olmetec

    • Drug: Dapagliflozin
    First stage: ATB-1012 for 5days, repeated administration, Second stage: ATB-1012 + ATB-1011 for 5days, repeated administration
    Other Names:
  • brand name: Forxiga

    		•
    Active Comparator: Arm B

    ATB-1012: 1tab/d for 5days / ATB-1011+ATB-1012: each 1tab/d for 5days

    Drug: Olmesartan
    First stage: ATB-1011 for 5days, repeated administration, Second stage: ATB-1012 + ATB-1011 for 5days, repeated administration
    Other Names:
  • brand name: Olmetec

    • Drug: Dapagliflozin
    First stage: ATB-1012 for 5days, repeated administration, Second stage: ATB-1012 + ATB-1011 for 5days, repeated administration
    Other Names:
  • brand name: Forxiga

    		•

    Outcome Measures

    Primary Outcome Measures

    1. ATB-1011 AUCτ,ss [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.

    2. ATB-1012 AUCτ,ss, [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.

    3. ATB-1011 Cmax,ss [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. ATB-1012 Cmax,ss [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.

    Secondary Outcome Measures

    1. ATB-1011 Tmax,ss [5days, 10days]

      Pharmacokinetic parameters are calculated using a noncompartmental method and descriptive statistics of pharmacokinetic endpoints are presented for each investigational product administration group.

    2. ATB-1011 Cmin,ss [5days, 10days]

      Pharmacokinetic parameters are calculated using a noncompartmental method and descriptive statistics of pharmacokinetic endpoints are presented for each investigational product administration group.

    3. ATB-1012 Tmax,ss [5days, 10days]

      Pharmacokinetic parameters are calculated using a noncompartmental method and descriptive statistics of pharmacokinetic endpoints are presented for each investigational product administration group.

    4. ATB-1012 Cmin,ss [5days, 10days]

      Pharmacokinetic parameters are calculated using a noncompartmental method and descriptive statistics of pharmacokinetic endpoints are presented for each investigational product administration group.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. Those who are over 19 years old at the screening visit

    2. 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

    3. 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

    4. 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.

    Exclusion Criteria:
      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.
    1. 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
    2. 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 H Plus Yangji Hospital Seoul Gwanak-gu Korea, Republic of 08779

    Sponsors and Collaborators

    • Autotelicbio

    Investigators

    • Principal Investigator: KyungWan Nam, Pharm. D., Autotelic.bio

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Autotelicbio
    ClinicalTrials.gov Identifier:
    NCT04856969
    Other Study ID Numbers:
    • ATB-101-001
    First Posted:
    Apr 23, 2021
    Last Update Posted:
    Sep 5, 2021
    Last Verified:
    Aug 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Dapagliflozin
    Olmesartan

    Study Results

    No Results Posted as of Sep 5, 2021