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

Sponsor
HK inno.N Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT04486157
Collaborator
(none)
44
1
2
1.7
25.3

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1

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 Design

Study Type:
Interventional
Actual Enrollment :
44 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
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
Actual Study Start Date :
Mar 18, 2021
Actual Primary Completion Date :
Apr 26, 2021
Actual Study Completion Date :
May 10, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. AUC0-t 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]

    Area under the plasma concentration versus time curve of netupitant

Secondary Outcome Measures

  1. 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]

    Peak Plasma Concentration of fosnetupitant, netupitant metabolites and palonosetron

  2. 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]

    Time to reach maximum (peak) plasma concentration of fosnetupitant, netupitant, netupitant metabolites and palonosetron

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Catholic Univ. of Seoul St. Mary's Hospital Seoul Korea, Republic of

Sponsors and Collaborators

  • HK inno.N Corporation

Investigators

  • Principal Investigator: Seunghoon Han, The Catholic University of Korea

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
HK inno.N Corporation
ClinicalTrials.gov Identifier:
NCT04486157
Other Study ID Numbers:
  • IN_FNP_101
First Posted:
Jul 24, 2020
Last Update Posted:
Jun 1, 2021
Last Verified:
May 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jun 1, 2021