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Completed

NCT Number: NCT04856969

Clinical Trial to Evaluate 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.

Completed

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Key information

Conditions

Healthy Adult Volunteers

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

H Plus Yangji Hospital

Seoul, Gwanak-gu, 08779, South Korea

About this study

  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

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.
  • 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.

Treatment and study plan

Olmesartan

Drug

First stage: ATB-1011 for 5days, repeated administration, Second stage: ATB-1012 + ATB-1011 for 5days, repeated administration

Other names: brand name: Olmetec

Dapagliflozin

Drug

First stage: ATB-1012 for 5days, repeated administration, Second stage: ATB-1012 + ATB-1011 for 5days, repeated administration

Other names: brand name: Forxiga

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. ATB-1011 Tmax,ss

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 5days, 10days

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

Sponsors and collaborators

Lead sponsor

Autotelicbio

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 23, 2021
Registry last updated
Sep 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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