Effect of Tegoprazan or RAPA114 on Pharmacokinetic of Atorvastatin in Healthy Adult Volunteers

NCT04221321 | Completed Phase 1

• 1 other identifier: IN_APA_114
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• AUCτ of atorvastatin

  Area under the plasma drug concentration-time curve at steady state

  Pre-dose on Day 1,5,6,7 and post-dose up to 24 hours on Day 7 in each period

• Css,max of atorvastatin

  Maximum concentration of drug in plasma of atorvastatin at steady state

  Pre-dose on Day 1,5,6,7 and post-dose up to 24 hours on Day 7 in each period

Secondary Outcomes (4)

• Tss,max of atorvastatin

  Pre-dose on Day 1,5,6,7 and post-dose up to 24 hours on Day 7 in each period

• AUCτ of 2-OH atorvastatin

  Pre-dose on Day 1,5,6,7 and post-dose up to 24 hours on Day 7 in each period

• Css,max of 2-OH atorvastatin

  Pre-dose on Day 1,5,6,7 and post-dose up to 24 hours on Day 7 in each period

• metabolic ratio

  Pre-dose on Day 1,5,6,7 and post-dose up to 24 hours on Day 7 in each period

Study Arms (3)

Atorvastatin 40 mg

PLACEBO COMPARATOR

Oral administration of Atorvastatin 40 mg tablet once daily for 7 days

Drug: Atorvastatin 40 mg

Atorvastatin 40 mg + Tegoprazan 50 mg

EXPERIMENTAL

Oral administration of Atorvastatin 40 mg tablet and Tegoprazan 50 mg tablet once daily for 7 days

Drug: Atorvastatin 40 mg; Drug: Tegoprazan 50 mg

Atorvastatin 40 mg + RAPA114

ACTIVE COMPARATOR

Oral administration of Atorvastatin 40 mg tablet and RAPA114 tablet once daily for 7 days

Drug: Atorvastatin 40 mg; Drug: RAPA114

Interventions

Atorvastatin 40 mg DRUG

Atorvastatin 40 mg

Also known as: Lipitor

Atorvastatin 40 mg; Atorvastatin 40 mg + RAPA114; Atorvastatin 40 mg + Tegoprazan 50 mg

Tegoprazan 50 mg DRUG

Tegoprazan 50 mg tablet

Also known as: K-CAB

Atorvastatin 40 mg + Tegoprazan 50 mg

RAPA114 DRUG

RAPA114 tablet

Atorvastatin 40 mg + RAPA114

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• HK inno.N Corporation: lead

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

MeSH Terms

Interventions

Atorvastatin; tegoprazan

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Jung-ryul Kim

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 6, 2020
• First Posted: January 9, 2020
• Study Start: January 7, 2020
• Primary Completion: March 12, 2020
• Study Completion: April 20, 2020
• Last Updated: December 1, 2020

Record last verified: 2020-06

Locations

KR (1)