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

A Phase 1, Open Label, Randomized, Single Dose, Two Treatment, Two Sequence, Two Period, Crossover Bioequivalence and Safety Study of IN-A012 and Akynzeo Capsules in Male and Female Healthy Korean Subjects

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: IN-A012; Drug: Akynzeo 300Mg-0.5Mg Capsule

Detailed Description

[Pharmacokinetics Assessment]

• Primary Parameter

  - AUC0-t

• Secondary Parameters - Cmax, tmax

[Safety Assessment]

- Adverse events, vital signs, physical examination, 12-lead ECGs, and clinical laboratory tests

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Catholic Univ. of Seoul St. Mary's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Healthy adults aged between 19-45
2. Body weight ≥ 50kg and in the range of ideal body weight ± 20%
3. Without congenital, or chronic diseases within recent 5 years
4. Subjects who are deemed eligible based on the screening tests
5. 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
6. Agree to use acceptable contraceptive methods from signing the informed consent to 3 weeks after the last dose of the investigational product
7. Able and willing to comply with study requirements including all scheduled inpatient and outpatient visits, clinical laboratory tests, and instructions.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IN-A012; Intravenous administration of IN-A012	Drug: IN-A012; The subjects will be given IN-A012 by Intravenous infusion over 30 minutes.
Active Comparator: Akynzeo capsules; Single oral administration of Akynzeo capsules	Drug: Akynzeo 300Mg-0.5Mg Capsule; The subjects will be administrated Akynzeo by Orally with water.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax of fosnetupitant, netupitant, netupitant metabolites and palonosetron	Peak Plasma Concentration of fosnetupitant, 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	Time to reach maximum (peak) plasma concentration 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

Collaborators and Investigators

• Sponsor: HK inno.N Corporation
• Investigators: Principal Investigator: SeungHoon Han, The Catholic University of Korea

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2021
• Primary Completion (Actual): April 26, 2021
• Study Completion (Actual): May 10, 2021

Study Registration Dates

• First Submitted: July 17, 2020
• First Submitted That Met QC Criteria: July 22, 2020
• First Posted (Actual): July 24, 2020

Study Record Updates

• Last Update Posted (Actual): June 1, 2021
• Last Update Submitted That Met QC Criteria: May 28, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: IN_FNP_101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No