Clinical trial NCT04221321: Effect of Tegoprazan or RAPA114 on Pharmacokinetic of Atorvastatin in Healthy Adult Volunteers
Official title: An Open-label, Randomized, Multiple-dose, Replicated Crossover Study to Evaluate Drug-drug Interaction Following Co-administration of Tegoprazan or RAPA114 With Atorvastatin in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: HK inno.N Corporation
Sponsor class: INDUSTRY
First posted: 2020-01-09
Enrollment: 32
Sex: MALE
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the influence of tegoprazan or RAPA114 on the Pharmacokinetic characteristics of atorvastatin following co-administration of tegoprazan or RAPA114 in healthy adult volunteers.

Detailed description: \[Pharmacokinetic Assessments\] : Blood concentration of atorvastatin, 2-OH atorvastatin

* Primary outcome: AUCτ, Css,max of atorvastatin
* Secondary outcome: Tss,max of atorvastatin, AUCτ, Css,max of 2-OH atorvastatin, metabolic ratio

\[Sefety Assessments\]

: Safety assessments with adverse event monitoring including subjective/objective symptoms, physical examination, vital signs, electrocardiogram, and laboratory test

Eligibility criteria: Inclusion Criteria:

* Healthy male adults aged 19 to 55 years (inclusive) at the time of his consent.
* Body mass index (BMI) ≥ 19.0 and ≤ 27.0 kg/m2 at screening.
* Decides to participate voluntarily in the trial after being fully informed of and understanding the study completely, and provides the written informed consent to participate in the trial and to comply with the trial-specific requirements.
* Has the ability and willingness to participate in the entire period of clinical trial.

Exclusion Criteria:

* A subject with clinically significant disease or history of hepatobiliary, renal, gastrointestinal, cardiovascular, musculoskeletal, endocrine, respiratory, neuropsychiatry or hemato-oncologic system, etc.
* A subject with a history of hypersensitivity reactions to main constituents of or identical affiliation of the investigational products (ex, HMG-CoA reductase inhibitor, gastric acid suppressants), or have allergic diseases that require treatment.
* A subject with a history of genetic myopathy or family history.
* A subject who has participated in other clinical trials and received the investigational products within 180 days prior to the randomization.
* A subject who received any medications or foods that could significantly affect the absorption, distribution, metabolism, or excretion of an investigational product within 30 days prior to the randomization.
* A subject with history of whole blood donation within 60 days, or with blood components or received transfusion within 30 days prior to the randomization.
* A subject with continued consumption of alcohol more than 140 g per week.
* A subject with AST, ALT, or γ-GT levels exceeding 1.5 times of the upper limit of the reference range in the screening test.
* A subject with a calculated glomerular filtration rate of less than 60 mL / min / 1.73 m2 in the screening test.
* A subject with any positive result on serology tests for hepatitis B, hepatitis C, HIV or syphilis in the screening test.
* A subject with galactose intolerance, Lapp lactose dehydrogenase deficiency or glucose-galactose malabsorption, etc.
* Male subject who don't have willing to accept medically acceptable contraceptive methods during the course of clinical trial, or who plan to provide sperm.
* A subject who is determined to be ineligible to participate in the clinical trial by the investigator for other reasons.

Primary outcomes:
measure: AUCτ of atorvastatin
timeFrame: Pre-dose on Day 1,5,6,7 and post-dose up to 24 hours on Day 7 in each period
measure: Css,max of atorvastatin
timeFrame: Pre-dose on Day 1,5,6,7 and post-dose up to 24 hours on Day 7 in each period
Secondary outcomes:
measure: Tss,max of atorvastatin
timeFrame: Pre-dose on Day 1,5,6,7 and post-dose up to 24 hours on Day 7 in each period
measure: AUCτ of 2-OH atorvastatin
timeFrame: Pre-dose on Day 1,5,6,7 and post-dose up to 24 hours on Day 7 in each period
measure: Css,max of 2-OH atorvastatin
timeFrame: Pre-dose on Day 1,5,6,7 and post-dose up to 24 hours on Day 7 in each period
measure: metabolic ratio
timeFrame: Pre-dose on Day 1,5,6,7 and post-dose up to 24 hours on Day 7 in each period
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Jung-ryul Kim
role: PRINCIPAL_INVESTIGATOR
References: