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

NCT04856969 | Completed Phase 1

• 1 other identifier: ATB-101-001
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Adult Volunteers

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  5days, 10days

Secondary Outcomes (4)

• ATB-1011 Tmax,ss

  5days, 10days

• ATB-1011 Cmin,ss

  5days, 10days

• ATB-1012 Tmax,ss

  5days, 10days

• ATB-1012 Cmin,ss

  5days, 10days

Study Arms (2)

Arm A

ACTIVE COMPARATOR

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

Drug: Olmesartan; Drug: Dapagliflozin

Arm B

ACTIVE COMPARATOR

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

Drug: Olmesartan; Drug: Dapagliflozin

Interventions

Olmesartan DRUG

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

Also known as: brand name: Olmetec

Arm A; Arm B

Dapagliflozin DRUG

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

Also known as: brand name: Forxiga

Arm A; Arm B

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Autotelicbio: lead

Study Sites (1)

H Plus Yangji Hospital

Seoul, Gwanak-gu, 08779, South Korea

Location

MeSH Terms

Interventions

olmesartan; dapagliflozin

Study Officials

• KyungWan Nam, Pharm. D.

  Autotelic.bio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 2 Intervention group, open, single-sequence, multiple oral administration crossover design

Study Record Dates

• First Submitted: April 20, 2021
• First Posted: April 23, 2021
• Study Start: March 30, 2021
• Primary Completion: May 4, 2021
• Study Completion: May 4, 2021
• Last Updated: September 5, 2021

Record last verified: 2021-08

Locations

KR (1)