Bioequivalence and Safety Study of IN-A012 and Akynzeo Capsules in Male and Female Healthy Korean Subjects

NCT04486157 | Completed Phase 1

• 1 other identifier: IN_FNP_101
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of this study is to demonstrate the bioequivalence between IN-A012 and Akynzeo capsules by pharmacokinetic(PK) evaluation

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• AUC0-t of netupitant

  Area under the plasma concentration versus time curve of netupitant

  pre-dose(0hour), 0.5, 1, 2, 3, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96 , 120, 144, 168, 192, 216, and 240 hours post-dose

Secondary Outcomes (2)

• Cmax of fosnetupitant, netupitant, netupitant metabolites and palonosetron

  pre-dose(0hour), 0.5, 1, 2, 3, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96 , 120, 144, 168, 192, 216, and 240 hours post-dose

• tmax of fosnetupitant, netupitant, netupitant metabolites and palonosetron

  pre-dose(0hour), 0.5, 1, 2, 3, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96 , 120, 144, 168, 192, 216, and 240 hours post-dose

Study Arms (2)

IN-A012

EXPERIMENTAL

Intravenous administration of IN-A012

Drug: IN-A012

Akynzeo capsules

ACTIVE COMPARATOR

Single oral administration of Akynzeo capsules

Drug: Akynzeo 300Mg-0.5Mg Capsule

Interventions

IN-A012 DRUG

The subjects will be given IN-A012 by Intravenous infusion over 30 minutes.

IN-A012

Akynzeo 300Mg-0.5Mg Capsule DRUG

The subjects will be administrated Akynzeo by Orally with water.

Akynzeo capsules

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adults aged between 19-45
• Body weight ≥ 50kg and in the range of ideal body weight ± 20%
• Without congenital, or chronic diseases within recent 5 years
• Subjects who are deemed eligible based on the screening tests
• Subjects who received a full explanation of the study, understood the purpose and details of this study, characteristics of the investigational product, and expected adverse events, and voluntarily signed the informed consent form
• Agree to use acceptable contraceptive methods from signing the informed consent to 3 weeks after the last dose of the investigational product
• Able and willing to comply with study requirements including all scheduled inpatient and outpatient visits, clinical laboratory tests, and instructions.

You may not qualify if:

• A subject with symptoms suspected of acute illness at the screening
• A subject with clinically significant and active cardiovascular, respiratory, kidney, endocrine, hematological, gastrointestinal, central nervous system diseases, psychiatric disorders, or malignant tumors
• A history of gastrointestinal disease
• Known hypersensitivity to the active ingredient or excipients of investigational product or a history of clinically significant hypersensitivity
• A history of drug abuse
• Pregnant women or women who may be pregnant, and breastfeeding women
• Subjects who are deemed inappropriate to participate in the study by the investigator for other reasons

Sponsors & Collaborators

• HK inno.N Corporation: lead

Study Sites (1)

Catholic Univ. of Seoul St. Mary's Hospital

Seoul, South Korea

Location

MeSH Terms

Interventions

netupitant, palosentron drug combination

Study Officials

• Seunghoon Han

  The Catholic University of Korea

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 17, 2020
• First Posted: July 24, 2020
• Study Start: March 18, 2021
• Primary Completion: April 26, 2021
• Study Completion: May 10, 2021
• Last Updated: June 1, 2021

Record last verified: 2021-05

Locations

KR (1)