Clinical trial NCT04856969: Clinical Trial to Evaluate Pharmacokinetic Interaction of ATB-1011 and ATB-1012 in Healthy Adult Volunteers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Adult Volunteers
Lead sponsor: Autotelicbio
Sponsor class: INDUSTRY
First posted: 2021-04-23
Enrollment: 38
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 2 Intervention group, open, single-sequence, multiple oral administration crossover design
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

2) 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.

Primary outcomes:
measure: ATB-1011 AUCτ,ss
timeFrame: 5days, 10days
measure: ATB-1012 AUCτ,ss,
timeFrame: 5days, 10days
measure: ATB-1011 Cmax,ss
timeFrame: 5days, 10days
measure: ATB-1012 Cmax,ss
timeFrame: 5days, 10days
Secondary outcomes:
measure: ATB-1011 Tmax,ss
timeFrame: 5days, 10days
measure: ATB-1011 Cmin,ss
timeFrame: 5days, 10days
measure: ATB-1012 Tmax,ss
timeFrame: 5days, 10days
measure: ATB-1012 Cmin,ss
timeFrame: 5days, 10days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: H Plus Yangji Hospital
state: Gwanak-gu
Study officials:
affiliation: Autotelic.bio
name: KyungWan Nam, Pharm. D.
role: PRINCIPAL_INVESTIGATOR
References: